Suicidal IdeationSUPERCEDERCTNCT07534358
Intensive Case Management Between VA and Community Care for Suicide Prevention
A study testing SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) and Present centered therapy in people with Suicidal Ideation and Mental Health Issue, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to build the evidence base for SUPERCEDE, a suicide prevention focused intensive case management intervention to increase access, improve care coordination, provide suicide prevention monitoring, and procure a timely response of VA mental health and suicide prevention… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Suicidal Ideation, Mental Health Issue, Social Determinants of Health
- What is being tested?
- SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) and Present centered therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolled in the VA Eastern Colorado Health Care System (ECHCS)
- able to complete an online questionnaire
- age 18-80 years
- able to comprehend and provide virtual informed consent
- receiving both VA care and VA authorized community care, through the MISSION Act, which is related to any physical or mental health disorder
- Veteran's non-VA care is authorized (i.e., non-VA care/treatment approved in advance by the VA)
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- at risk for suicide, which is defined as any 1 of the following circumstances: a) prior lifetime suicide attempt; b) suicidal ideation in the past month; c) current mental health symptoms, defined as PHQ-9 >10, or PCL-5 >31
- psychosocial challenges reported on the ACORN or Assessment of Needs measure
- issues with VA community care coordination (i.e., Veteran reported challenges, consults canceled in medical record, appointments canceled or rescheduled in medical record, etc.)
- receiving no or infrequent mental health services at the VA (e.g., seen less than once a month by a mental health provider).
Who cannot join
- not at imminent risk of suicide or homicide warranting crisis intervention (will be able to participate once stabilized)
- unable or unwilling to participate in the intervention (e.g., unwilling to provide VA community care information, etc.)
- without access to a device capable of telephone calls or video calls
- presenting with any situation which the principal investigator deems this type of care is inappropriate for the Veteran.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eastern Colorado Healthcare System
Aurora, Colorado, 80045
Bryann DeBeer, PhD, 254-987-0341, Bryann.DeBeer@va.gov
About this study
Official title: Improving Access to VA Mental Health and Suicide Prevention Services: A Randomized Clinical Trial of Intensive Case Management Between VA and Community Care (SUPERCEDE RCT)
The goal of this randomized clinical trial is to build the evidence base for SUPERCEDE, a suicide prevention focused intensive case management intervention to increase access, improve care coordination, provide suicide prevention monitoring, and procure a timely response of VA mental health and suicide prevention services among VA-enrolled veterans receiving VA authorized community care. This phase is a hybrid effectiveness Type 1 randomized control trial, which will include 2 arms: the treatment intervention, SUPERCEDE, and the control intervention, present centered therapy. The main questions it aims to answer are:• This RCT will continue to build the evidence base for effectiveness and determine feasibility and acceptability for the previously piloted SUPERCEDE. • This RCT will improve the understanding of implementation of this intervention, both in VA and VA authorized community care organizations in preparation for broader implementation. Researchers will compare SUPERCEDE and present centered therapy to see if SUPERCEDE results in improved functioning and a decrease in suicidal ideation. Participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan (CRP), intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions.
Detailed Description For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT. Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.
Read the detailed description
For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT.
Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.
- Being tested
- SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE), Present centered therapy
- Keywords
- suicide prevention, Veteran
- Medical subject headings
- Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)Behavioural
Intensive Case Management
Present centered therapyBehavioural
Control group receiving present centered therapy.
| Study group | Role | What they receive |
|---|---|---|
| SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) | Experimental | SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA community care coordination. Receives: Behavioral: SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) |
| Present centered therapy (PCT) | Active comparator | PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions with a safety plan if needed. Receives: Behavioral: Present centered therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functioning: Brief Inventory of Psychosocial Functioning (B-IPF)
B-IPF is a 7-item measure of interpersonal functioning. Scores range from 0 (not at all) to 6 (very much), with higher scores indicating worse functioning. Investigators will fit linear mixed models for the outcome variable of functioning with the between-subject factor of treatment (SUPERCEDE vs. PCT), the within- subject factor of time, and the interaction between two factors (treatment X time). Several correlation structures will be considered for repeated measures within individuals, and the best fitting structure based on Akaike Information Criterion (AIC) will be selected. Significant treatment by time interaction, with significant differences at follow-up on the B-IPF, will be considered supportive of our hypothesis.
Measured: Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up
Suicidal Ideation: Brief Beck Scale for Suicidal Ideation (BSSI)
The BSSI is a 21-item self report measure assessing suicidal ideation and behaviors. Scores range from 0 (no suicidal risk ideation/behaviors) to 2 (suicidal ideation/behaviors). Greater scores indicate greater suicidal ideation and behaviors. Responses will be dichotomized. The dichotomous variable (e.g., no suicidal ideation vs. suicidal ideation), and the continuous variable of suicidal ideation, when endorsed. To analyze the dichotomous outcome, a logistic regression for zero vs. nonzero values will be conducted. For the continuous variable, a zero-inflated negative binomial regression will be performed.
Measured: Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
Formative evaluation of SUPERCEDE
A formative evaluation will be conducted to understand optimal conditions of implementing the intervention both within the VA and in VA community care agencies. Qualitative interviews will be conducted with stakeholders (n = 20) in VA and VA community care agencies. The formative evaluation will be focused on the following: 1) understand how the intervention could further be developed for both VA and community context; 2) improve understanding of the recipients (e.g., social workers, psychologists, etc.) and their needs; 3) gain perspectives from stakeholders regarding the innovation itself to improve implementation; 4) identify facilitators and barriers to wide-spread implementation.
Measured: 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Aug 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and present centered therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Bryann DeBeer, VA Eastern Colorado Health Care System
- Investigators
- Bryann B DeBeer, PhD, Principal investigator, Eastern Colorado Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534358
- Sponsor's protocol ID
- 20-1995
- Acronym
- SUPERCEDERCT
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cully, J.A., Dawson, D.B., Hamer, J., & Tharp, A.L. (2020). A provider's guide to Brief Cognitive Behavioral Therapy. Department of Veterans Affairs South Central MIRECC, Houston, TX.
Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.
PubMed 28967323Frost ND, Laska KM, Wampold BE. The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. J Trauma Stress. 2014 Feb;27(1):1-8. doi: 10.1002/jts.21881.
PubMed 24515534
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to VA Mental Health and Suicide Prevention Services: A Randomized Clinical Trial of Intensive Case Management Between VA and Community Care (SUPERCEDE RCT)
- ClinicalTrials.gov ID
- NCT07534358
- Acronym / sponsor ID
- SUPERCEDERCT / 20-1995
- Keywords
- suicide prevention, Veteran
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to build the evidence base for SUPERCEDE, a suicide prevention focused intensive case management intervention to increase access, improve care coordination, provide suicide prevention monitoring, and procure a timely response of VA mental health and suicide prevention services among VA-enrolled veterans receiving VA authorized community care. This phase is a hybrid effectiveness Type 1 randomized control trial, which will include 2 arms: the treatment intervention, SUPERCEDE, and the control intervention, present centered therapy. The main questions it aims to answer are:• This RCT will continue to build the evidence base for effectiveness and determine feasibility and acceptability for the previously piloted SUPERCEDE. • This RCT will improve the understanding of implementation of this intervention, both in VA and VA authorized community care organizations in preparation for broader implementation. Researchers will compare SUPERCEDE and present centered therapy to see if SUPERCEDE results in improved functioning and a decrease in suicidal ideation. Participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan (CRP), intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions.
Detailed Description For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT. Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.
Detailed description
For hypothesis 3a: Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and PCT.
Recruitment. Eligible participants will be identified through the VA Rocky Mountain Regional (RMR) Medical Center the VA Corporate Data Warehouse (CDW), flyers and advertisements, or through clinician or community referral. A recruitment letter will be sent to participants identified in the CDW. Investigators will attempt to contact potential participants with a warm call by telephone (up to 3 times) after the letter is sent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Overall, 100 participants will be randomized to either SUPERCEDE or present centered therapy (PCT) plus a safety plan if warranted. SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA authorized community care coordination. PCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions. The study therapist is trained in both SUPERCEDE and present centered therapy.
| Arm | Type | Receives |
|---|---|---|
| SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) | Experimental | Behavioral: SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)SUPERCEDE is a suicide prevention case management intervention that combines BCBT-SP, a Crisis Response Plan, intensive case management to alleviate suicide risk factors, and VA community care coordination. |
| Present centered therapy (PCT) | Active comparator | Behavioral: Present centered therapyPCT is an active control condition often used in clinical trials of posttraumatic stress disorder. The intervention focuses on the present moment and encouraging the client to find solutions to their problems. In this trial, investigators will mirror the sessions of PCT to SUPERCEDE. Thus, the control group will receive 3 sessions, with an optional 3 additional sessions with a safety plan if needed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- enrolled in the VA Eastern Colorado Health Care System (ECHCS)
- able to complete an online questionnaire
- age 18-80 years
- able to comprehend and provide virtual informed consent
- receiving both VA care and VA authorized community care, through the MISSION Act, which is related to any physical or mental health disorder
Key exclusion criteria (4 listed)
- not at imminent risk of suicide or homicide warranting crisis intervention (will be able to participate once stabilized)
- unable or unwilling to participate in the intervention (e.g., unwilling to provide VA community care information, etc.)
- without access to a device capable of telephone calls or video calls
- presenting with any situation which the principal investigator deems this type of care is inappropriate for the Veteran.
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 |
|---|---|---|
| SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE)Intensive Case Management | Behavioural | SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) |
| Present centered therapyControl group receiving present centered therapy. | Behavioural | Present centered therapy (PCT) |
Primary outcome
Functioning: Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up
B-IPF is a 7-item measure of interpersonal functioning. Scores range from 0 (not at all) to 6 (very much), with higher scores indicating worse functioning. Investigators will fit linear mixed models for the outcome variable of functioning with the between-subject factor of treatment (SUPERCEDE vs. PCT), the within- subject factor of time, and the interaction between two factors (treatment X time). Several correlation structures will be considered for repeated measures within individuals, and the best fitting structure based on Akaike Information Criterion (AIC) will be selected. Significant treatment by time interaction, with significant differences at follow-up on the B-IPF, will be considered supportive of our hypothesis.
Suicidal Ideation: Brief Beck Scale for Suicidal Ideation (BSSI)
Time frame: Baseline (Time 1), 5 weeks (Time 2), 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
The BSSI is a 21-item self report measure assessing suicidal ideation and behaviors. Scores range from 0 (no suicidal risk ideation/behaviors) to 2 (suicidal ideation/behaviors). Greater scores indicate greater suicidal ideation and behaviors. Responses will be dichotomized. The dichotomous variable (e.g., no suicidal ideation vs. suicidal ideation), and the continuous variable of suicidal ideation, when endorsed. To analyze the dichotomous outcome, a logistic regression for zero vs. nonzero values will be conducted. For the continuous variable, a zero-inflated negative binomial regression will be performed.
Formative evaluation of SUPERCEDE
Time frame: 9 weeks (post-treatment; Time 3), 6-month follow-up (Time 4)
A formative evaluation will be conducted to understand optimal conditions of implementing the intervention both within the VA and in VA community care agencies. Qualitative interviews will be conducted with stakeholders (n = 20) in VA and VA community care agencies. The formative evaluation will be focused on the following: 1) understand how the intervention could further be developed for both VA and community context; 2) improve understanding of the recipients (e.g., social workers, psychologists, etc.) and their needs; 3) gain perspectives from stakeholders regarding the innovation itself to improve implementation; 4) identify facilitators and barriers to wide-spread implementation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- BackgroundCully, J.A., Dawson, D.B., Hamer, J., & Tharp, A.L. (2020). A provider's guide to Brief Cognitive Behavioral Therapy. Department of Veterans Affairs South Central MIRECC, Houston, TX.
- Background: PubMed 28967323Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.
- Background: PubMed 24515534Frost ND, Laska KM, Wampold BE. The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. J Trauma Stress. 2014 Feb;27(1):1-8. doi: 10.1002/jts.21881.
- Individual participant dataSharing planned: No
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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.
Bryann B DeBeer, PhD principal investigator
Eastern Colorado Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUicidE PRevention intensive CasE management and coorDination in Community CarE (SUPERCEDE) and Present centered therapy in people with Suicidal Ideation and Mental Health Issue, run by VA Eastern Colorado Health Care System 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 10 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: looking for participants now, as of the sponsor's last update on 16 Apr 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryann B DeBeer, PhD (254-987-0341, Bryann.DeBeer@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functioning: Brief Inventory of Psychosocial Functioning (B-IPF) (time frame: Baseline (Time 1), 5 weeks, 9 weeks (post-treatment), 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534358, which also lists 3 linked publications.
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 16 Apr 2026.