ClinicalTrials.gg
RecruitingNCT05537376Updated Jul 10, 2026

A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness

An interventional study of SUicide Prevention by Peers Offering Recovery Tactics in Psychotic Disorders, Bipolar Disorders and Suicidal Ideation, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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, 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.

02

Conditions studied

  • Psychotic Disorders
  • Bipolar Disorders
  • Suicidal Ideation
  • Suicide, Attempted
03

In context

Psychotic Disorders

1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.

This study's planned enrollment of 69 is close to the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.

Browse Psychotic Disorders studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Veteran Inclusion Criteria:

  1. 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
  2. Current SMI diagnosis (i.e., schizophrenia and other psychotic disorders, mood disorders with psychotic features, bipolar disorders)
  3. Capable of via the University of California San Diego Brief Assessment of Capacity to Consent (UBACC)

Peer Specialist Inclusion Criteria:

  1. 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. 2-3 years of experience post certification as a Certified Peer Specialist
  3. Interest in being trained in SUPPORT
  4. 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
  5. 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.

Exclusion criteria

Exclusion Criteria:

Veteran Exclusion Criteria:

  1. Cannot complete the assessment battery
  2. Current intoxication requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services
  3. Imminent psychiatric hospitalization
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (estimated)

Study arms

  • Experimental
    SUPPORT

    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.

    Behavioral: SUicide Prevention by Peers Offering Recovery Tactics

  • No intervention
    ESC

    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.

Interventions

  • BehavioralSUicide Prevention by Peers Offering Recovery Tactics

    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.

    Also known as: SUPPORT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 4 years

  2. 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.

    Time frame: At the end of the intervention, an average of 4-weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline, 2-weeks, 4-weeks, 3-month follow-up

  2. 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.

    Time frame: Baseline, 2-weeks, 4-weeks, 3-month follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 40834400 ↗
  • Chalker 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jul 2027, 45 months after the start.

Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 45 months is above that.

Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2022
First posted
Sep 13, 2022
StartActual
Sep 12, 2023
Primary completionEst.
Jul 1, 2027
CompletionEst.
Oct 31, 2027
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537376
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Sep 12, 2023
Primary completion
Jul 1, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Samantha A Chalker, PhD
Contact
Samantha.Chalker1@va.gov
(619) 680-1735
Colin A Depp, PhD
Contact
Colin.Depp@va.gov
(858) 822-4251
Samantha A Chalker, PhD
principal investigator · VA San Diego Healthcare System, San Diego, CA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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