Psychotic DisordersNCT05537376
A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
A study testing SUicide Prevention by Peers Offering Recovery Tactics in people with Psychotic Disorders and Bipolar Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Bipolar Disorders, Suicidal Ideation
- What is being tested?
- SUicide Prevention by Peers Offering Recovery Tactics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran Inclusion Criteria:
- Veterans who report present suicidal ideation (i.e., Columbia-Suicide Severity Rating Scale (C-SSRS) > 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the C-SSRS
- Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)
- Capable of informed consent via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
- Peer Specialist Inclusion Criteria:
- Certified Peer Specialist employed at VA San Diego Healthcare System (VASDHS) in the Mental Health Care Line (individuals must demonstrate competency in basic suicide screening and referral procedures to be certified)
Show all 10Show fewer
- 2-3 years of experience post certification as a Certified Peer Specialist
- Interest in being trained in SUPPORT
- Provide verbal or written consent for the research staff to discuss ability to participate in the study with the Peer Specialist's direct clinical supervisor
- Direct clinical supervisor agreement to allow the Peer Specialist to participate. This includes the Peer Specialist's direct clinical supervisor agreement to allow the Peer Specialist time as part of their current scope of practice to 1) participate in the full day (8-hour) SUPPORT training, 2) participate in weekly 1-hour group supervision for the duration of the Peer Specialist's time in the study, and 3) take on a case load of at least one SUPPORT Veteran at a given time.
Who cannot join
- Veteran Exclusion Criteria:
- Cannot complete the assessment battery
- Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
- Imminent psychiatric hospitalization
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
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Samantha A Chalker, PhD, 619-680-1735, Samantha.Chalker1@va.gov
Samantha A Chalker, PhD
About this study
Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.
Read the detailed description
This 5-year study aims to refine and pilot a peer-delivered intervention to improve functional and social recovery to decrease suicide risk; the study consists of two phases. Phase 1 employs a user-centered design approach to refine SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT) aided by scientific and consumer advisory board stakeholders as well as training Peer Specialists to fidelity on pilot cases in an open trial. SUPPORT is a flexibly delivered intervention intended to augment safety planning by addressing functional and social goals personalized to each Veteran's recovery following a suicidal crisis while including cognitive learning strategies to enhance recall and salience of intervention material. Following adaptations from Phase 1, Phase 2 includes a pilot randomized controlled trial of SUPPORT compared to an enhanced standard care condition. Veteran participants in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment (and qualitatively interviewed at post-treatment). Peer Specialists delivering the intervention will also be qualitatively interviewed post-treatment. The primary outcomes to be evaluated is improvement in personal recovery and reduction in suicidal ideation severity. Secondary outcomes concern changes in various domains of personal and social functioning.
- Being tested
- SUicide Prevention by Peers Offering Recovery Tactics
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUicide Prevention by Peers Offering Recovery TacticsBehavioural
Also called SUPPORT
Following the completion of a comprehensive mental health evaluation by a licensed VA provider, which includes a suicide safety plan, if a Veteran is having active thoughts of suicide or made a suicide attempt in past three months, they may be eligible for SUPPORT. In SUPPORT, the Peer Specialist and Veteran co-create a personalized suicide-focused recovery plan (SUPPORT Plan) in flexible, 50-minute weekly encounters. The SUPPORT Plan includes modules that focus on valuing recovery, building a hope kit and daily plan, setting recovery goals, and looking ahead to enhance the Veteran's safety plan. Learning strategies are incorporated into each module to promote salience and recall of intervention material. The Peer Specialist works closely with the Veteran's treatment team and uses the most recent safety plan in the Veteran's chart to help complete the SUPPORT Plan as well as reinforce the usage of the Veteran's safety plan.
| Study group | Role | What they receive |
|---|---|---|
| SUPPORT | Experimental | Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery. Receives: Behavioral: SUicide Prevention by Peers Offering Recovery Tactics |
| ESC | No intervention | The enhanced standard care (ESC) condition contains the elements of standard practice suicide prevention delivered at VHA, which include: 1) suicide risk assessment, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, and 4) Suicide Prevention Coordinator follow-up contacts. It is enhanced due to the contact with the research study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment and retention
Recruitment and retention is determined by the number of participants who were initially contacted, consented, completed baseline data, and completed follow-up data.
Measured: Through study completion, an average of 4 years
Acceptability of SUPPORT as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 brief survey has been used extensively in VA and non-VA settings to assess overall satisfaction with care, and it has excellent internal consistency (0.93). An overall score" is calculated by summing the participant's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: At the end of the intervention, an average of 4-weeks
Secondary outcomes (2)
Change in the Scale for Suicide Ideation (SSI)
The SSI is an 19-item interviewer administered assessment of suicidal ideation (SI) severity. The total score ranges from 0 to 38 with higher scores indicating more serve SI. The scale has demonstrated strong validity and reliability.
Measured: Baseline, 2-weeks, 4-weeks, 3-month follow-up
Change in Recovery Assessment Scale-41
The RAS-41 is a self-report measure of personal recovery with five domains: personal confidence and hope; willingness to ask for help; goal and success orientation; reliance on others; no domination by symptoms. A review study found high Cronbach's alphas (.76 and .97) and test-retest reliability (.65 to .88). The RAS has been widely used in VA and non-VA clinical trial studies with diverse populations, a range of mental illnesses, and has demonstrated sensitivity to change over time.
Measured: Baseline, 2-weeks, 4-weeks, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start12 Sep 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery.
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Samantha A Chalker, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537376
- Sponsor's protocol ID
- D4239-W
- Status last verified
- Jul 2026
- First submitted
- 7 Sep 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chalker S, Carter J, Imai Y, Depp C, Chinman M. A Recovery-Oriented Suicide Prevention Program Led by Peer Specialists for Veterans With Serious Mental Illness: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 20;14:e66182. doi: 10.2196/66182.
PubMed 40834400Chalker SA, Serafez J, Imai Y, Stinchcomb J, Mendez E, Depp CA, Twamley EW, Fortuna KL, Goodman M, Chinman M. Suicide Prevention by Peers Offering Recovery Tactics (SUPPORT) for US Veterans With Serious Mental Illness: Community Engagement Approach. J Particip Med. 2024 May 23;16:e56204. doi: 10.2196/56204.
PubMed 38781010
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05537376
- Acronym / sponsor ID
- D4239-W
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 Sep 2022 (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.
Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.
Detailed description
This 5-year study aims to refine and pilot a peer-delivered intervention to improve functional and social recovery to decrease suicide risk; the study consists of two phases. Phase 1 employs a user-centered design approach to refine SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT) aided by scientific and consumer advisory board stakeholders as well as training Peer Specialists to fidelity on pilot cases in an open trial. SUPPORT is a flexibly delivered intervention intended to augment safety planning by addressing functional and social goals personalized to each Veteran's recovery following a suicidal crisis while including cognitive learning strategies to enhance recall and salience of intervention material. Following adaptations from Phase 1, Phase 2 includes a pilot randomized controlled trial of SUPPORT compared to an enhanced standard care condition. Veteran participants in both phases will be quantitatively assessed at baseline, mid-treatment, post-treatment, and 3-months post-treatment (and qualitatively interviewed at post-treatment). Peer Specialists delivering the intervention will also be qualitatively interviewed post-treatment. The primary outcomes to be evaluated is improvement in personal recovery and reduction in suicidal ideation severity. Secondary outcomes concern changes in various domains of personal and social functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Veterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery.
| Arm | Type | Receives |
|---|---|---|
| SUPPORT | Experimental | Behavioral: SUicide Prevention by Peers Offering Recovery TacticsVeterans receiving SUPPORT will be offered all modules of the intervention via weekly, 50-minute sessions with a Peer Specialist. Following the completion of a mental health evaluation by a licensed professional, the Peer Specialist leads the Veteran who is at risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance recall of the Veteran's safety plan and improve recovery. |
| ESC | No intervention | –The enhanced standard care (ESC) condition contains the elements of standard practice suicide prevention delivered at VHA, which include: 1) suicide risk assessment, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, and 4) Suicide Prevention Coordinator follow-up contacts. It is enhanced due to the contact with the research study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Veterans who report present suicidal ideation (i.e., Columbia-Suicide Severity Rating Scale (C-SSRS) > 2 ("Active thoughts of killing oneself") in past 1 month and/or a suicide attempt in the prior 3 months as identified by the C-SSRS
- Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)
- Capable of informed consent via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)
- Certified Peer Specialist employed at VA San Diego Healthcare System (VASDHS) in the Mental Health Care Line (individuals must demonstrate competency in basic suicide screening and referral procedures to be certified)
- 2-3 years of experience post certification as a Certified Peer Specialist
Key exclusion criteria (4 listed)
- Cannot complete the assessment battery
- Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
- Imminent psychiatric hospitalization
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 by Peers Offering Recovery TacticsAlso: SUPPORTFollowing the completion of a comprehensive mental health evaluation by a licensed VA provider, which includes a suicide safety plan, if a Veteran is having active thoughts of suicide or made a suicide attempt in past three months, they may be eligible for SUPPORT. In SUPPORT, the Peer Specialist and Veteran co-create a personalized suicide-focused recovery plan (SUPPORT Plan) in flexible, 50-minute weekly encounters. The SUPPORT Plan includes modules that focus on valuing recovery, building a hope kit and daily plan, setting recovery goals, and looking ahead to enhance the Veteran's safety plan. Learning strategies are incorporated into each module to promote salience and recall of intervention material. The Peer Specialist works closely with the Veteran's treatment team and uses the most recent safety plan in the Veteran's chart to help complete the SUPPORT Plan as well as reinforce the usage of the Veteran's safety plan. | Behavioural | SUPPORT |
Primary outcome
Feasibility of recruitment and retention
Time frame: Through study completion, an average of 4 years
Recruitment and retention is determined by the number of participants who were initially contacted, consented, completed baseline data, and completed follow-up data.
Acceptability of SUPPORT as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: At the end of the intervention, an average of 4-weeks
The CSQ-8 brief survey has been used extensively in VA and non-VA settings to assess overall satisfaction with care, and it has excellent internal consistency (0.93). An overall score" is calculated by summing the participant's rating score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
2 secondary outcomes
Change in the Scale for Suicide Ideation (SSI)
Time frame: Baseline, 2-weeks, 4-weeks, 3-month follow-up
Change in Recovery Assessment Scale-41
Time frame: Baseline, 2-weeks, 4-weeks, 3-month follow-up
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 10 Jul 2026.
- Derived from this study: PubMed 40834400Chalker S, Carter J, Imai Y, Depp C, Chinman M. A Recovery-Oriented Suicide Prevention Program Led by Peer Specialists for Veterans With Serious Mental Illness: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 20;14:e66182. doi: 10.2196/66182.
- Derived from this study: PubMed 38781010Chalker SA, Serafez J, Imai Y, Stinchcomb J, Mendez E, Depp CA, Twamley EW, Fortuna KL, Goodman M, Chinman M. Suicide Prevention by Peers Offering Recovery Tactics (SUPPORT) for US Veterans With Serious Mental Illness: Community Engagement Approach. J Particip Med. 2024 May 23;16:e56204. doi: 10.2196/56204.
- 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.
Samantha A Chalker, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
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 by Peers Offering Recovery Tactics in people with Psychotic Disorders and Bipolar Disorders, run by VA Office of Research and Development 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 10 Jul 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 Samantha A Chalker, PhD ((619) 680-1735, Samantha.Chalker1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment and retention (time frame: Through study completion, an average of 4 years). The study lists 2 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 NCT05537376, which also lists 2 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 10 Jul 2026.