Trial Outcomes & Findings for Modulating Repetitive Negative Thinking Related Brain Networks in Young Adults With Depression (NCT NCT06219681)
NCT ID: NCT06219681
Last Updated: 2026-06-17
Results Overview
Functional connectivity between rAI and rSTS was assessed using psychophysiological interaction (PPI) analysis of fMRI BOLD signal. Beta-values derived from PPI analysis represent the strength of connectivity; higher positive values indicate stronger functional coupling between regions. Change scores were calculated as post-intervention beta-value minus pre-intervention beta-value within Visit 1. A negative value indicates reduced connectivity following neurofeedback.
TERMINATED
NA
54 participants
Immediately post-intervention during Visit 1 (day 1)
2026-06-17
Participant Flow
Participants were recruited from the Tulsa metropolitan area through the Laureate Institute for Brain Research (LIBR). Recruitment methods included outreach by the LIBR clinical team, as well as newspaper, flyers, radio, and Facebook advertisements. The study targeted young adults (ages 18-35) with Major Depressive Disorder. Recruitment began in January 2024 and was terminated prematurely due to the Principal Investigator's departure.
A total of 54 participants signed the informed consent form, but only 42 were randomized and assigned to study arms. The remaining 12 participants were excluded prior to group assignment due to screening failures (e.g., exclusionary psychiatric diagnoses, positive drug tests, pregnancy), loss to follow-up, or voluntary withdrawal before the first visit.
Participant milestones
| Measure |
Active Neurofeedback
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
Sham Neurofeedback
Receiving artificially generated feedback signals.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Active Neurofeedback
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
Sham Neurofeedback
Receiving artificially generated feedback signals.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Of 42 randomized participants, 27 had usable fMRI data at Visit 1 (Active n=15, Sham n=12). Remaining 15 were excluded due to fMRI data quality issues such as excessive head motion.
Baseline characteristics by cohort
| Measure |
Active Neurofeedback
n=22 Participants
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
Sham Neurofeedback
n=20 Participants
Receiving artificially generated feedback signals.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.3 years old
STANDARD_DEVIATION 4.9 • n=22 Participants
|
27.1 years old
STANDARD_DEVIATION 5.8 • n=20 Participants
|
27.2 years old
STANDARD_DEVIATION 5.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=22 Participants
|
16 Participants
n=20 Participants
|
33 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=22 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=22 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=22 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=22 Participants
|
10 Participants
n=20 Participants
|
24 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=22 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=22 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=42 Participants
|
|
Functional Connectivity between rAI and rSTS at baseline
|
0.3170 beta-values
STANDARD_DEVIATION 0.5142 • n=15 Participants • Of 42 randomized participants, 27 had usable fMRI data at Visit 1 (Active n=15, Sham n=12). Remaining 15 were excluded due to fMRI data quality issues such as excessive head motion.
|
0.1474 beta-values
STANDARD_DEVIATION 0.2001 • n=12 Participants • Of 42 randomized participants, 27 had usable fMRI data at Visit 1 (Active n=15, Sham n=12). Remaining 15 were excluded due to fMRI data quality issues such as excessive head motion.
|
0.2416 beta-values
STANDARD_DEVIATION 0.4083 • n=27 Participants • Of 42 randomized participants, 27 had usable fMRI data at Visit 1 (Active n=15, Sham n=12). Remaining 15 were excluded due to fMRI data quality issues such as excessive head motion.
|
|
Brief State Rumination Inventory (BSRI) Total Score at Baseline
|
383.36 score
STANDARD_DEVIATION 179.97 • n=22 Participants
|
455.05 score
STANDARD_DEVIATION 201.94 • n=20 Participants
|
417.50 score
STANDARD_DEVIATION 191.84 • n=42 Participants
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Baseline
|
19.18 score
STANDARD_DEVIATION 7.27 • n=22 Participants • One participant (Sham) was missing MADRS data at Visit 1, resulting in n=41 (Active n=22, Sham n=19).
|
16.84 score
STANDARD_DEVIATION 7.73 • n=19 Participants • One participant (Sham) was missing MADRS data at Visit 1, resulting in n=41 (Active n=22, Sham n=19).
|
18.10 score
STANDARD_DEVIATION 7.48 • n=41 Participants • One participant (Sham) was missing MADRS data at Visit 1, resulting in n=41 (Active n=22, Sham n=19).
|
PRIMARY outcome
Timeframe: Immediately post-intervention during Visit 1 (day 1)Population: Of the 42 randomized participants (Active n=22, Sham n=20), 27 had complete fMRI data for Visit 1 and were included in the analysis (Active n=15, Sham n=12). Participants were excluded due to missing Visit 1 fMRI data or data quality issues such as excessive head motion.
Functional connectivity between rAI and rSTS was assessed using psychophysiological interaction (PPI) analysis of fMRI BOLD signal. Beta-values derived from PPI analysis represent the strength of connectivity; higher positive values indicate stronger functional coupling between regions. Change scores were calculated as post-intervention beta-value minus pre-intervention beta-value within Visit 1. A negative value indicates reduced connectivity following neurofeedback.
Outcome measures
| Measure |
Sham Neurofeedback
n=12 Participants
Receiving artificially generated feedback signals.
|
Active Neurofeedback
n=15 Participants
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
|---|---|---|
|
Functional Connectivity Change Between Right Anterior Insular (rAI) and Right Superior Temporal Sulcus (rSTS) Within Visit1
|
0.5553 beta-value
Standard Deviation 0.1594
|
-0.1140 beta-value
Standard Deviation 0.0731
|
SECONDARY outcome
Timeframe: From baseline (pre-scan at Visit 1, Day 1) to immediately after neurofeedback intervention (post-scan at Visit 1, Day 1)Population: All 42 randomized participants who completed Visit 1 were included in the analysis (Active n=22, Sham n=20).
The BSRI is a self-report scale to measure state rumination. A higher score indicates higher state rumination with a maximum score of 800 and the minimum score of 0. Change scores were calculated as post-intervention score minus pre-intervention score at Visit 1. A negative change score indicates reduction in state rumination.
Outcome measures
| Measure |
Sham Neurofeedback
n=20 Participants
Receiving artificially generated feedback signals.
|
Active Neurofeedback
n=22 Participants
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
|---|---|---|
|
Changes in Brief State Rumination Inventory (BSRI) Total Score From Pre- to Post-Intervention at Visit 1
|
-3.20 score
Standard Deviation 265.07
|
70.82 score
Standard Deviation 175.72
|
SECONDARY outcome
Timeframe: From baseline at Visit 1 (Day 1) to follow-up at Visit 2 (1 week after Visit 1)Population: Of the 42 randomized participants (Active n=22, Sham n=20), 36 had MADRS data at both visits and were included in the analysis (Active n=18, Sham n=18). Six participants were excluded due to missing Visit 1 (n=1) or Visit 2 assessments (n=5).
The MADRS is an interviewer-rated scale to measure the severity of depressive symptoms. A higher score indicates severer depression with a maximum score of 60 and a minimum score of 0. Change scores were calculated as Visit 2 score minus Visit 1 score. A negative change score indicates improvement in depressive symptoms.
Outcome measures
| Measure |
Sham Neurofeedback
n=18 Participants
Receiving artificially generated feedback signals.
|
Active Neurofeedback
n=18 Participants
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Follow-up
|
-2.44 score
Standard Deviation 6.64
|
-1.44 score
Standard Deviation 5.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline scan at Visit 1 (Day 1) to follow-up scan at Visit 2 (1 week after Visit 1)Population: Of the 42 randomized participants (Active n=22, Sham n=20), 19 had complete fMRI data for both visits (Active n=8, Sham n=11). Participants were excluded due to missing Visit 2 (n=10), fMRI data quality issues such as excessive head motion, or incomplete task run acquisition.
Functional connectivity between rAI and rSTS was assessed using psychophysiological interaction (PPI) analysis of fMRI BOLD signal. Beta-values derived from PPI analysis represent the strength of connectivity; higher positive values indicate stronger functional coupling between regions. Change scores were calculated as Visit 2 beta-value minus Visit 1 beta-value.
Outcome measures
| Measure |
Sham Neurofeedback
n=11 Participants
Receiving artificially generated feedback signals.
|
Active Neurofeedback
n=8 Participants
Receiving feedback signals from the repetitive negative thinking (RNT)-related brain functional connectivity
|
|---|---|---|
|
Functional Connectivity Change Between Right Anterior Insular (rAI) and Right Superior Temporal Sulcus (rSTS) From Visit1 to Follow-up (Visit 2)
|
-0.0037 beta-value
Standard Deviation 0.2300
|
0.0044 beta-value
Standard Deviation 0.1754
|
Adverse Events
Active Neurofeedback
Sham Neurofeedback
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aki Tsuchiyagaito
Laureate Institute for Brain Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place