Suicide, AttemptedPhase 1NCT06183580
Teen Brain Training (TBT)
A Phase 1 study testing neurofeedback training involving dACC and neurofeedback training involving amygdala in people with Suicide, Attempted and Suicide, Ideation, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Attempted, Suicide, Ideation, Depression
- What is being tested?
- neurofeedback training involving dACC and neurofeedback training involving amygdala
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2022to 18 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents with a history of suicide attempts
Who cannot join
- Psychotic disorders.
- Primary substance use disorder.
- Primary anorexic disorder.
- Autism Spectrum Disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
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.
Read the detailed description
This phased innovation application in response garnered support for an initial (R61) 2-year phase for milestone-driven testing of neural targets of intervention by a novel neurofeedback treatment. Using neurofeedback (NF) we targeted the neurocircuitry of affect regulation and self-processing in adolescents and young adults (ages 11-18) with current significant suicide ideation and a history of a recent suicide attempt. Attaining our the milestones would trigger support for three additional years (R33 phase) to confirm target engagement in a larger sample with random assignment to active NF intervention vs. Placebo NF, to assess the relationships between target engagement and changes in functional outcomes. Affect dysregulation and abnormal self-processing are known to contribute to poor long-term outcomes and predict repeated suicide attempts in at risk populations. They are insufficiently addressed by medications or most existing behavioral treatments. NF training has resulted in enduring improvements in those dimensions in prior Placebo controlled NF trials. To further develop this intervention, we first identified the neural target best engaged by NF during a critical developmental period for affect regulation and self-processing. Our pilot data and theoretical considerations supported the overarching hypothesis that increased amygdala or dACC activity and their functional connectivity (FC) with the middle prefrontal cortex (mPFC) represented treatable targets via NF training. Accordingly, in the initial R61 phase measured intervention-related increases in dACC and right amygdala activity and their FC with mPFC during self-processing and affect regulation tasks with high-quality imaging and clinical data obtained during, before and after NF training. The goal of the R61 phase was to determine which loci is best up-regulated by the targeted population and was best associated with amelioration in the target functional outcomes. If we were to meet our proposed milestones that the increase in dACC or right amygdala and their FC with the mPFC exceeded a specific effect size and account for an appreciable proportion of the variance in behavioral measures of affect regulation and self-processing, we would proceed to the R33 phase. In the R33 phase, we would expand the study to test adolescents randomized to the active NF intervention (dACC or Amygdala) or to a placebo NF who would provide complete high quality pre- and post-intervention and clinical data. We obtained state-of-the-art magnetic resonance imaging (MRI) data with a primary focus on functional MRI. Our specific aims in the R33 phase would be to confirm target engagement in the groups randomized to active vs. the Placebo NF group; to examine the relationship between changes in the neural target and clinical improvements in affect regulation, self-processing and suicide ideation; and to identify mediators of improved functional outcomes. Evidence supporting the validity of dACC or amygdala circuits as a modifiable neural target would then support future studies to further enhance the effectiveness of neurofeedback in adolescents. Importantly, even negative results would be informative regarding the location and direction of neurofeedback (top=dACC vs. down=amygdala) that best attains substantial effects. Inconclusive results from brain imaging would still inform Bayesian priors for future studies of the neural substrates of affect regulation and self-processing impairments and their amelioration.
- Conditions
- Suicide, Attempted, Suicide, Ideation, Depression
- Being tested
- neurofeedback training involving dACC, neurofeedback training involving amygdala
- Medical subject headings
- Suicide, Attempted, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedback training involving dACCOther
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.
neurofeedback training involving amygdalaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| dACC Arm | Experimental | Participants assigned to the Neurofeedback from the dorsal anterior cingulate cortex Receives: Other: neurofeedback training involving dACC |
| rAMY Arm | Experimental | Participants assigned to the Neurofeedback from the amygdala Receives: Other: neurofeedback training involving amygdala |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = Wish to be dead
- = Non-specific active suicidal thoughts
- = Active suicidal ideation with method (not plan)
- = Active suicidal ideation with some intent (no specific plan)
- = Active suicidal ideation with specific plan and intent
Measured: 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
- = Wish to be dead
- = Non-specific active suicidal thoughts
- = Active suicidal ideation with method (not plan)
- = Active suicidal ideation with some intent (no specific plan)
- = Active suicidal ideation with specific plan and intent
Measured: 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
- = Wish to be dead
- = Non-specific active suicidal thoughts
- = Active suicidal ideation with method (not plan)
- = Active suicidal ideation with some intent (no specific plan)
- = Active suicidal ideation with specific plan and intent
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 8
Secondary outcomes (13)
Difficulties in Emotion Regulation (DERS) - Visit 1
The 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.
Measured: Day 0
Difficulties in Emotion Regulation (DERS) - Visit 2
The 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.
Measured: Week 5
Difficulties in Emotion Regulation (DERS) - Visit 3
The 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.
Measured: Week 8
Difficulties in Emotion Regulation (DERS) - Visit 4
The 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.
Measured: Week 11
Difficulties in Emotion Regulation (DERS) - Visit 5
The 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.
Measured: Week 16
Responses to Depression (RD) - Visit 1
This 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.
Measured: Day 0
Responses to Depression (RD) - Visit 2
This 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.
Measured: Week 5
Responses to Depression (RD) - Visit 3
This 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.
Measured: Week 8
Responses to Depression (RD) - Visit 4
This 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.
Measured: Week 11
Responses to Depression (RD) - Visit 5
This 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.
Measured: Week 16
Children's Depression Rating Scale - Visit 1
For 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.
Measured: Day 0
Children's Depression Rating Scale - Visit 4
For 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.
Measured: Week 11
Children's Depression Rating Scale - Visit 5
For 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.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start28 May 2022
- Primary completion18 Feb 2024
- Study completion18 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing two different targets of treatment: either amygdala or dorsal anterior cingulate cortex neurofeedback
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Karina Quevedo, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183580
- Sponsor's protocol ID
- PSYCH-2020-29400
- Other IDs
- 1R61MH122634-01
- Status last verified
- Mar 2026
- First submitted
- 13 Dec 2023
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
- ClinicalTrials.gov ID
- NCT06183580
- Acronym / sponsor ID
- PSYCH-2020-29400
- Conditions
- Suicide, Attempted, Suicide, Ideation, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 May 2022 (actual)
- Primary completion
- 18 Feb 2024 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phased innovation application in response garnered support for an initial (R61) 2-year phase for milestone-driven testing of neural targets of intervention by a novel neurofeedback treatment. Using neurofeedback (NF) we targeted the neurocircuitry of affect regulation and self-processing in adolescents and young adults (ages 11-18) with current significant suicide ideation and a history of a recent suicide attempt. Attaining our the milestones would trigger support for three additional years (R33 phase) to confirm target engagement in a larger sample with random assignment to active NF intervention vs. Placebo NF, to assess the relationships between target engagement and changes in functional outcomes. Affect dysregulation and abnormal self-processing are known to contribute to poor long-term outcomes and predict repeated suicide attempts in at risk populations. They are insufficiently addressed by medications or most existing behavioral treatments. NF training has resulted in enduring improvements in those dimensions in prior Placebo controlled NF trials. To further develop this intervention, we first identified the neural target best engaged by NF during a critical developmental period for affect regulation and self-processing. Our pilot data and theoretical considerations supported the overarching hypothesis that increased amygdala or dACC activity and their functional connectivity (FC) with the middle prefrontal cortex (mPFC) represented treatable targets via NF training. Accordingly, in the initial R61 phase measured intervention-related increases in dACC and right amygdala activity and their FC with mPFC during self-processing and affect regulation tasks with high-quality imaging and clinical data obtained during, before and after NF training. The goal of the R61 phase was to determine which loci is best up-regulated by the targeted population and was best associated with amelioration in the target functional outcomes. If we were to meet our proposed milestones that the increase in dACC or right amygdala and their FC with the mPFC exceeded a specific effect size and account for an appreciable proportion of the variance in behavioral measures of affect regulation and self-processing, we would proceed to the R33 phase. In the R33 phase, we would expand the study to test adolescents randomized to the active NF intervention (dACC or Amygdala) or to a placebo NF who would provide complete high quality pre- and post-intervention and clinical data. We obtained state-of-the-art magnetic resonance imaging (MRI) data with a primary focus on functional MRI. Our specific aims in the R33 phase would be to confirm target engagement in the groups randomized to active vs. the Placebo NF group; to examine the relationship between changes in the neural target and clinical improvements in affect regulation, self-processing and suicide ideation; and to identify mediators of improved functional outcomes. Evidence supporting the validity of dACC or amygdala circuits as a modifiable neural target would then support future studies to further enhance the effectiveness of neurofeedback in adolescents. Importantly, even negative results would be informative regarding the location and direction of neurofeedback (top=dACC vs. down=amygdala) that best attains substantial effects. Inconclusive results from brain imaging would still inform Bayesian priors for future studies of the neural substrates of affect regulation and self-processing impairments and their amelioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Comparing two different targets of treatment: either amygdala or dorsal anterior cingulate cortex neurofeedback
| Arm | Type | Receives |
|---|---|---|
| dACC Arm | Experimental | Other: neurofeedback training involving dACCParticipants assigned to the Neurofeedback from the dorsal anterior cingulate cortex |
| rAMY Arm | Experimental | Other: neurofeedback training involving amygdalaParticipants assigned to the Neurofeedback from the amygdala |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents with a history of suicide attempts
Key exclusion criteria (4 listed)
- Psychotic disorders.
- Primary substance use disorder.
- Primary anorexic disorder.
- Autism Spectrum Disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurofeedback training involving dACCParticipants 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. | Other | dACC Arm |
| neurofeedback training involving amygdalaParticipants 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. | Other | rAMY Arm |
Primary outcome
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1
Time frame: Day 0
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
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 4
Time frame: Week 11
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
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 5
Time frame: Week 16
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
Suicide Ideation Questionnaire (SIQ) - Visit 1
Time frame: Day 0
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
Suicide Ideation Questionnaire (SIQ) - Visit 4
Time frame: Week 11
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
Suicide Ideation Questionnaire (SIQ) - Visit 5
Time frame: Week 16
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
Neural Target Engagement - Visit 2
Time frame: Week 5
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.
Neural Target Engagement - Visit 3
Time frame: Week 8
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.
13 secondary outcomes
Difficulties in Emotion Regulation (DERS) - Visit 1
Time frame: Day 0
Difficulties in Emotion Regulation (DERS) - Visit 2
Time frame: Week 5
Difficulties in Emotion Regulation (DERS) - Visit 3
Time frame: Week 8
Difficulties in Emotion Regulation (DERS) - Visit 4
Time frame: Week 11
Difficulties in Emotion Regulation (DERS) - Visit 5
Time frame: Week 16
Responses to Depression (RD) - Visit 1
Time frame: Day 0
Responses to Depression (RD) - Visit 2
Time frame: Week 5
Responses to Depression (RD) - Visit 3
Time frame: Week 8
Responses to Depression (RD) - Visit 4
Time frame: Week 11
Responses to Depression (RD) - Visit 5
Time frame: Week 16
Children's Depression Rating Scale - Visit 1
Time frame: Day 0
Children's Depression Rating Scale - Visit 4
Time frame: Week 11
Children's Depression Rating Scale - Visit 5
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Suicide, Attempted
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Quevedo principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing neurofeedback training involving dACC and neurofeedback training involving amygdala in people with Suicide, Attempted and Suicide, Ideation, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (CSSRS) - Visit 1 (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.