Trial Outcomes & Findings for Teen Brain Training (TBT) (NCT NCT06183580)
NCT ID: NCT06183580
Last Updated: 2026-03-03
Results Overview
The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
157 participants
Primary outcome timeframe
Day 0
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
dACC Arm
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
80
|
|
Overall Study
COMPLETED
|
61
|
66
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
dACC Arm
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
16
|
11
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Teen Brain Training (TBT)
Baseline characteristics by cohort
| Measure |
dACC Arm
n=77 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=80 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
77 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
157 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
121 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
36 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
7 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
10 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=41 Participants
|
54 Participants
n=35 Participants
|
99 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
31 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Day 0The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Outcome measures
| Measure |
dACC Arm
n=63 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=65 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1
|
2.08 points
Standard Deviation 1.71
|
2.37 points
Standard Deviation 1.65
|
PRIMARY outcome
Timeframe: Week 11The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Outcome measures
| Measure |
dACC Arm
n=63 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=64 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 4
|
1.75 points
Standard Deviation 1.76
|
1.77 points
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Week 16The CSSRS has a scale 0-5 with 0 indicating no suicide ideation and 5 indicating suicide ideation with intent and plan. Higher values are considered the worst outcome The units are ordinal units scored by a clinician following the descriptions in the instrument. Suicidal Ideation Severity Subscale: This core scale has a range of 0 to 5. 0 = No suicidal ideation 1. = Wish to be dead 2. = Non-specific active suicidal thoughts 3. = Active suicidal ideation with method (not plan) 4. = Active suicidal ideation with some intent (no specific plan) 5. = Active suicidal ideation with specific plan and intent
Outcome measures
| Measure |
dACC Arm
n=60 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=61 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 5
|
1.17 points
Standard Deviation 1.28
|
1.03 points
Standard Deviation 1.21
|
PRIMARY outcome
Timeframe: Day 0Total Suicide Ideation. The suicide ideation questionnaire is a self report measure, higher values indicatemore severe suicide ideation. The total score can range between a minimum of 0 to a maximum 180 (for the 30-item version). A sum of 41 or higher is a common cut-off score indicating the need for further evaluation. Higher scores mean a worse outcome
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Suicide Ideation Questionnaire (SIQ) - Visit 1
|
61.45 units on a scale
Standard Deviation 38.2
|
64.27 units on a scale
Standard Deviation 36.28
|
PRIMARY outcome
Timeframe: Week 11Total Suicide Ideation. The suicide ideation questionnaire is a self report measure, higher values indicatemore severe suicide ideation. The total score can range between a minimum of 0 to a maximum 180 (for the 30-item version). A sum of 41 or higher is a common cut-off score indicating the need for further evaluation. Higher scores mean a worse outcome
Outcome measures
| Measure |
dACC Arm
n=63 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=66 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Suicide Ideation Questionnaire (SIQ) - Visit 4
|
52.05 units on a scale
Standard Deviation 34.8
|
50.09 units on a scale
Standard Deviation 34.66
|
PRIMARY outcome
Timeframe: Week 16Total Suicide Ideation. The suicide ideation questionnaire is a self report measure, higher values indicatemore severe suicide ideation. The total score can range between a minimum of 0 to a maximum 180 (for the 30-item version). A sum of 41 or higher is a common cut-off score indicating the need for further evaluation. Higher scores mean a worse outcome
Outcome measures
| Measure |
dACC Arm
n=60 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=61 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Suicide Ideation Questionnaire (SIQ) - Visit 5
|
50.13 units on a scale
Standard Deviation 36.62
|
47.12 units on a scale
Standard Deviation 33.98
|
PRIMARY outcome
Timeframe: Week 5Activity for the Neural Target indicates level of blood oxigen level dependent activity as obtained via functional magnetic resonance imaging. Higher levels indicate more activity in the area of interest compared to baseline states of the brain.
Outcome measures
| Measure |
dACC Arm
n=53 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=54 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Neural Target Engagement - Visit 2
|
0.13 percentage of BOLD signal change
Standard Deviation 0.16
|
-0.04 percentage of BOLD signal change
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Week 8Activity for the Neural Target indicates level of blood oxigen level dependent activity as obtained via functional magnetic resonance imaging. Higher levels indicate more activity in the area of interest compared to baseline states of the brain.
Outcome measures
| Measure |
dACC Arm
n=53 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=54 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Neural Target Engagement - Visit 3
|
0.03 percentage of BOLD signal change
Standard Deviation 0.18
|
0.079 percentage of BOLD signal change
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Day 0The Difficulties in Emotion Regulation scale is a self-report questionnaire that measures difficulties with emotion regulation. To score the DERS in this study we scored each of the emotion dysregulation scales separately by addidng the items that comprised each scale and dividing the total by the number of items. The total DERS score was calculated by the following formula: COMPUTE ders\_average=MEAN(ders\_difficultygoal\_score,ders\_impulsecontrol\_score, ders\_lackemoclarity\_score,ders\_limaccesstoer\_score,ders\_lowemoaware\_score, ders\_nonacceptance\_score). Higher values indicate more difficulties with emotion regulation. It has a total score range of 9 to 25.33 for the full 36-item version, where higher scores indicate greater difficulty with emotion regulation.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Difficulties in Emotion Regulation (DERS) - Visit 1
|
18.5 points
Standard Deviation 4.05
|
17.71 points
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Week 5The Difficulties in Emotion Regulation scale is a self-report questionnaire that measures difficulties with emotion regulation. To score the DERS in this study we scored each of the emotion dysregulation scales separately by addidng the items that comprised each scale and dividing the total by the number of items. The total DERS score was calculated by the following formula: COMPUTE ders\_average=MEAN(ders\_difficultygoal\_score,ders\_impulsecontrol\_score, ders\_lackemoclarity\_score,ders\_limaccesstoer\_score,ders\_lowemoaware\_score, ders\_nonacceptance\_score). Higher values indicate more difficulties with emotion regulation. It has a total score range of 9 to 25.33 for the full 36-item version, where higher scores indicate greater difficulty with emotion regulation.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Difficulties in Emotion Regulation (DERS) - Visit 2
|
17.54 points
Standard Deviation 4.32
|
16.89 points
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: Week 8The Difficulties in Emotion Regulation scale is a self-report questionnaire that measures difficulties with emotion regulation. To score the DERS in this study we scored each of the emotion dysregulation scales separately by addidng the items that comprised each scale and dividing the total by the number of items. The total DERS score was calculated by the following formula: COMPUTE ders\_average=MEAN(ders\_difficultygoal\_score,ders\_impulsecontrol\_score, ders\_lackemoclarity\_score,ders\_limaccesstoer\_score,ders\_lowemoaware\_score, ders\_nonacceptance\_score). Higher values indicate more difficulties with emotion regulation. It has a total score range of 9 to 25.33 for the full 36-item version, where higher scores indicate greater difficulty with emotion regulation.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Difficulties in Emotion Regulation (DERS) - Visit 3
|
17.42 points
Standard Deviation 4.15
|
16.47 points
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Week 11The Difficulties in Emotion Regulation scale is a self-report questionnaire that measures difficulties with emotion regulation. To score the DERS in this study we scored each of the emotion dysregulation scales separately by addidng the items that comprised each scale and dividing the total by the number of items. The total DERS score was calculated by the following formula: COMPUTE ders\_average=MEAN(ders\_difficultygoal\_score,ders\_impulsecontrol\_score, ders\_lackemoclarity\_score,ders\_limaccesstoer\_score,ders\_lowemoaware\_score, ders\_nonacceptance\_score). Higher values indicate more difficulties with emotion regulation. It has a total score range of 9 to 25.33 for the full 36-item version, where higher scores indicate greater difficulty with emotion regulation.
Outcome measures
| Measure |
dACC Arm
n=63 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Difficulties in Emotion Regulation (DERS) - Visit 4
|
17.01 points
Standard Deviation 4.15
|
16.3 points
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: Week 16The Difficulties in Emotion Regulation scale is a self-report questionnaire that measures difficulties with emotion regulation. To score the DERS in this study we scored each of the emotion dysregulation scales separately by addidng the items that comprised each scale and dividing the total by the number of items. The total DERS score was calculated by the following formula: COMPUTE ders\_average=MEAN(ders\_difficultygoal\_score,ders\_impulsecontrol\_score, ders\_lackemoclarity\_score,ders\_limaccesstoer\_score,ders\_lowemoaware\_score, ders\_nonacceptance\_score). Higher values indicate more difficulties with emotion regulation. It has a total score range of 9 to 25.33 for the full 36-item version, where higher scores indicate greater difficulty with emotion regulation.
Outcome measures
| Measure |
dACC Arm
n=59 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=61 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Difficulties in Emotion Regulation (DERS) - Visit 5
|
17.08 points
Standard Deviation 3.99
|
15.73 points
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: Day 0This questionnaire measures the tendencies to dwell or ruminate about one's symptoms and depression. Higher scores indicate more difficulties with rumination. The score range is 22 to 88, with a total score calculated by summing the responses to its 22 items. Higher scores indicate a greater tendency to respond to sadness with rumination, which can include self-analysis, dwelling on one's anger, or brooding.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Responses to Depression (RD) - Visit 1
|
54.92 points
Standard Deviation 12.58
|
55.13 points
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: Week 5This questionnaire measures the tendencies to dwell or ruminate about one's symptoms and depression. Higher scores indicate more difficulties with rumination. The score range is 22 to 88, with a total score calculated by summing the responses to its 22 items. Higher scores indicate a greater tendency to respond to sadness with rumination, which can include self-analysis, dwelling on one's anger, or brooding.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Responses to Depression (RD) - Visit 2
|
51.35 points
Standard Deviation 14.04
|
49.72 points
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Week 8This questionnaire measures the tendencies to dwell or ruminate about one's symptoms and depression. Higher scores indicate more difficulties with rumination. The score range is 22 to 88, with a total score calculated by summing the responses to its 22 items. Higher scores indicate a greater tendency to respond to sadness with rumination, which can include self-analysis, dwelling on one's anger, or brooding.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Responses to Depression (RD) - Visit 3
|
49.2 points
Standard Deviation 13.89
|
48.37 points
Standard Deviation 14.42
|
SECONDARY outcome
Timeframe: Week 11This questionnaire measures the tendencies to dwell or ruminate about one's symptoms and depression. Higher scores indicate more difficulties with rumination. The score range is 22 to 88, with a total score calculated by summing the responses to its 22 items. Higher scores indicate a greater tendency to respond to sadness with rumination, which can include self-analysis, dwelling on one's anger, or brooding.
Outcome measures
| Measure |
dACC Arm
n=63 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Responses to Depression (RD) - Visit 4
|
50.21 points
Standard Deviation 13.32
|
47.46 points
Standard Deviation 15.06
|
SECONDARY outcome
Timeframe: Week 16This questionnaire measures the tendencies to dwell or ruminate about one's symptoms and depression. Higher scores indicate more difficulties with rumination. The score range is 22 to 88, with a total score calculated by summing the responses to its 22 items. Higher scores indicate a greater tendency to respond to sadness with rumination, which can include self-analysis, dwelling on one's anger, or brooding.
Outcome measures
| Measure |
dACC Arm
n=60 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=61 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Responses to Depression (RD) - Visit 5
|
49.32 points
Standard Deviation 14.2
|
43.64 points
Standard Deviation 15.16
|
SECONDARY outcome
Timeframe: Day 0For the Children's Depression Rating Scale-Revised (CDRS-R), which is clinician-rated, the total score ranges from 17 to 113. Higher values indicate a higher severity of child depression. Remission (minimal/no symptoms): \<=28. Moderate to Severe Depression\>=40.
Outcome measures
| Measure |
dACC Arm
n=64 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=68 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Children's Depression Rating Scale - Visit 1
|
46.42 points
Standard Deviation 16.59
|
47.91 points
Standard Deviation 16.65
|
SECONDARY outcome
Timeframe: Week 11For the Children's Depression Rating Scale-Revised (CDRS-R), which is clinician-rated, the total score ranges from 17 to 113. Higher values indicate a higher severity of child depression. Remission (minimal/no symptoms): \<=28. Moderate to Severe Depression\>=40.
Outcome measures
| Measure |
dACC Arm
n=60 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=62 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Children's Depression Rating Scale - Visit 4
|
43.58 points
Standard Deviation 16.47
|
43.36 points
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Week 16For the Children's Depression Rating Scale-Revised (CDRS-R), which is clinician-rated, the total score ranges from 17 to 113. Higher values indicate a higher severity of child depression. Remission (minimal/no symptoms): \<=28. Moderate to Severe Depression\>=40.
Outcome measures
| Measure |
dACC Arm
n=60 Participants
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=62 Participants
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Children's Depression Rating Scale - Visit 5
|
40.57 points
Standard Deviation 15.21
|
38.89 points
Standard Deviation 17.22
|
Adverse Events
dACC Arm
Serious events: 7 serious events
Other events: 1 other events
Deaths: 8 deaths
rAMY Arm
Serious events: 2 serious events
Other events: 1 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
dACC Arm
n=77 participants at risk
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=80 participants at risk
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
5.2%
4/77 • Number of events 4 • 16 Weeks
|
0.00%
0/80 • 16 Weeks
|
|
Psychiatric disorders
Interrupted/Aborted Suicide Attempt
|
3.9%
3/77 • Number of events 5 • 16 Weeks
|
2.5%
2/80 • Number of events 2 • 16 Weeks
|
Other adverse events
| Measure |
dACC Arm
n=77 participants at risk
Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex
neurofeedback training involving dACC: Participants are pseudorandomized to the dACC group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the dACC. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase dACC neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
rAMY Arm
n=80 participants at risk
Participants assigned to the Neurofeedback from the amygdala
neurofeedback training involving amygdala: Participants are pseudorandomized to the rAMY group to undergo neurofeedback (NF). NF training consists of four \~7.33 min NF training runs preceded by a 5 min baseline (no NF) and followed by a 5 min transfer run (no NF). Training entails NF blocks paired to a self-happy face along a bar that indicates changing levels of the rAMY. During the control condition, participants will count backward (CB) from 100 cued by an unfamiliar happy face with no NF. During rest conditions, participants see the cue "Rest" and are asked to relax with their eyes open. During NF, participants will try to increase rAMY neural activity by recalling happy memories. The colored bar indicating the neural activity will shift up or down depending on values provided by Turbo-BrainVoyager software. Green = Activity \> baseline and red = Activity \< baseline. Before and after NF training, suicide ideation severity, depression severity, and performance on self-processing behavioral tasks will be assessed.
|
|---|---|---|
|
Psychiatric disorders
Self-Harm
|
0.00%
0/77 • 16 Weeks
|
1.2%
1/80 • Number of events 1 • 16 Weeks
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/77 • Number of events 1 • 16 Weeks
|
0.00%
0/80 • 16 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place