Teen Brain Training (TBT)

NCT06183580 | Completed Phase 1 Results DMC

• 2 other identifiers: PSYCH-2020-294001R61MH122634-01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

A non invasive treatment study including participants at risk for suicide attempts and undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real time inside the scanner.

Conditions

Suicide, Attempted; Suicide, Ideation; Depression

Outcome Measures

Primary Outcomes (8)

• Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1

  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

  Day 0

• Columbia Suicide Severity Rating Scale (CSSRS) - Visit 4

  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

  Week 11

• Columbia Suicide Severity Rating Scale (CSSRS) - Visit 5

  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

  Week 16

• Suicide Ideation Questionnaire (SIQ) - Visit 1

  Total 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

  Day 0

• Suicide Ideation Questionnaire (SIQ) - Visit 4

  Total 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

  Week 11

• Suicide Ideation Questionnaire (SIQ) - Visit 5

  Total 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

  Week 16

• Neural Target Engagement - Visit 2

  Activity 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.

  Week 5

• Neural Target Engagement - Visit 3

  Activity 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.

  Week 8

Secondary Outcomes (13)

• Difficulties in Emotion Regulation (DERS) - Visit 1

  Day 0

• Difficulties in Emotion Regulation (DERS) - Visit 2

  Week 5

• Difficulties in Emotion Regulation (DERS) - Visit 3

  Week 8

• Difficulties in Emotion Regulation (DERS) - Visit 4

  Week 11

• Difficulties in Emotion Regulation (DERS) - Visit 5

  Week 16

Study Arms (2)

dACC Arm

EXPERIMENTAL

Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex

Other: neurofeedback training involving dACC

rAMY Arm

EXPERIMENTAL

Participants assigned to the Neurofeedback from the amygdala

Other: neurofeedback training involving amygdala

Interventions

neurofeedback training involving dACC OTHER

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.

dACC Arm

neurofeedback training involving amygdala OTHER

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.

rAMY Arm

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents with a history of suicide attempts

You may not qualify if:

• Psychotic disorders.
• Primary substance use disorder.
• Primary anorexic disorder.
• Autism Spectrum Disorder.

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicide; Depression

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

NIMH acknowledged we had met milestones to transition to the R33 grant, but didn't fund the R33. The R33 would have compared the best neurofeedback target to a placebo. Future research ought to compare particularly right amygdala neurofeedback to a placebo neurofeedback condition.

Results Point of Contact

• Title: Karina Quevedo
• Organization: University of Minnesota

queve001@umn.edu

612-273-9761

Study Officials

• Karina Quevedo

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparing two different targets of treatment: either amygdala or dorsal anterior cingulate cortex neurofeedback

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: May 28, 2022
• Primary Completion: February 18, 2024
• Study Completion: February 18, 2024
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-03

Locations

US (1)