Trial Outcomes & Findings for Effects of Amygdala Neurofeedback on Depressive Symptoms (NCT NCT02709161)
NCT ID: NCT02709161
Last Updated: 2024-12-27
Results Overview
The Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
10 weeks
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Real-time fMRI Neurofeedback: Amygdala
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
Real-time fMRI Neurofeedback: HIPS
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Real-time fMRI Neurofeedback: Amygdala
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
Real-time fMRI Neurofeedback: HIPS
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effects of Amygdala Neurofeedback on Depressive Symptoms
Baseline characteristics by cohort
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=19 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
Real-time fMRI Neurofeedback: HIPS
n=17 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 12 • n=99 Participants
|
31 years
STANDARD_DEVIATION 9 • n=107 Participants
|
32 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
17 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Beck Depression Inventory Baseline
|
27.2 units on a scale
STANDARD_DEVIATION 10.7 • n=99 Participants
|
26.6 units on a scale
STANDARD_DEVIATION 13.4 • n=107 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
PROMIS Baseline
|
68 t-score
STANDARD_DEVIATION 8 • n=99 Participants
|
66 t-score
STANDARD_DEVIATION 9 • n=107 Participants
|
67 t-score
STANDARD_DEVIATION 9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 10 weeksThe Beck Depression Inventory is a self-report questionnaire consisting of 21 questions assessing depressive symptoms. Scores can range from 0-63 with higher scores indicating more severe depression.
Outcome measures
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=18 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
Real-time fMRI Neurofeedback: HIPS
n=15 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
|---|---|---|
|
Beck Depression Inventory (BDI-II)
|
16.1 units on a scale
Standard Deviation 9.66
|
24.3 units on a scale
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: 10 weeksThe PROMIS depression measure is a self-report measure of depressive symptoms consisting of 8 questions. Scores can range from 0-40 with higher scores indicating greater severity of depression. The raw scores are converted to T scores with scores with a mean of 50 and a standard deviation of 10. Scores under 55 indicate no depression and scores above 70 indicate severe depression.
Outcome measures
| Measure |
Real-time fMRI Neurofeedback: Amygdala
n=18 Participants
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: Amygdala: Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
Real-time fMRI Neurofeedback: HIPS
n=15 Participants
HIPS neurofeedback - attempt to upregulate the left horizontal segment of the intraparietal sulcus (HIPS), a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback from the HIPS. Two sessions will be performed one week apart.
real-time fMRI neurofeedback: HIPS: Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
|
|---|---|---|
|
PROMIS Item Bank v1.0 - Depression
|
53 t-score
Standard Deviation 11
|
61 t-score
Standard Deviation 12
|
Adverse Events
Real-time fMRI Neurofeedback: Amygdala
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Real-time fMRI Neurofeedback: HIPS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place