An interventional study of Veteran Voices and Visions (VVV) and Wellness Recovery Action Planning (WRAP) in Psychotic Disorders, Hallucinations, Auditory and Social Isolation, sponsored by VA Office of Research and Development. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.
Veterans have a higher prevalence than non-Veterans of Schizophrenia-spectrum disorders (SSD). These Veterans often struggle with social integration-e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. They are at high risk of homelessness and suicide, and the impact on overall mortality is comparable to that of smoking and greater than obesity and alcohol abuse. SSD diagnoses are a significant cause of disability and a drain on VA resources. Auditory hallucinations (AH) are particularly linked to social withdrawal. Stigma against voice-hearing leads to silence, internalized shame, and social isolation, fueling cycles of avoidance and distress. Veteran Voices and Visions (VVV) is a psychosocial group intervention for Veterans with psychosis based on the Hearing Voices (HV) approach that reduces distress related to psychosis and builds a sense of belonging for Veterans living with psychosis. This intervention is hypothesized to increase social integration.
VVV takes a recovery-oriented, peer-led, Veteran-centered approach to understanding and reframing psychosis that emphasizes personal meaning and destigmatization. Pilot data indicates the approach reduces distress due to AH and fosters a sense of belonging. Research with Veterans with Serious Mental Illness (SMI) shows a high sense of belonging is protective against suicidal ideation. The proposed study would be the first ever to test the efficacy of a HV-inspired approach. If successful, it could transform how VA addresses psychosis by mobilizing the peer workforce to the benefit of a vulnerable group of Veterans.
Specific Aims: Aim 1: Assess VVV efficacy: At each site, 80 Veterans will be randomly assigned to receive 12 weeks of VVV or a Wellness Recovery Action Planning (WRAP) group. Facilitators will be regularly supervised, and group sessions will be video recorded for fidelity review. Veterans will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks) on the proximal outcomes of distress related to AH and sense of belonging, and distal outcome of social functioning. Secondary outcomes include severity of symptoms, self-efficacy, subjective recovery, self-stigma, loneliness, and hope.
Hypothesis: Veterans in VVV will have reduced distress due to AH and increased sense of belonging relative to Veterans in WRAP at the end of the intervention, and they will have increased social functioning at 24-week follow up.
Aim 2: Identify contextual factors that support or impede VVV implementation in the context of routine care. The investigators will use the updated Consolidation Framework for Implementation Research (CFIR) to guide interviews with VVV facilitators, and local and national mental health leadership. The investigators will use rapid analysis on the resulting qualitative data to assess the context to support implementation of VVV (if effective).
Methodology: This is a 4-year hybrid 1 efficacy trial comparing VVV and WRAP across 2 VA sites.
Path to Translation/Implementation: A hybrid 1 trial is when an intervention is tested for effectiveness while collecting implementation data that could inform future delivery in real-world settings. Adding implementation assessments is a modest investment that does not impede the full test of an intervention's effectiveness and speeds the pace of the research pipeline, which often moves evidence-based practices (EBPs) into real-world settings much too slowly. The next step could be an implementation-focused trial.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 160 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →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.
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.
Exclusion Criteria:
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a group-based, peer specialist and clinician co-facilitated psychosocial intervention for Veterans with serious mental illness (SMI), called "Veteran Voices and Visions" (VVV). VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of hallucinations, delusions, and social isolation.
Behavioral: Veteran Voices and Visions (VVV)
Wellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis.
Behavioral: Wellness Recovery Action Planning (WRAP)
This is a group-based, peer specialist and clinician co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV is an adaptation of a community-based support group model called the Hearing Voices (HV) approach. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of hallucinations, delusions, and social isolation.
Also known as: VVV
Wellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis.
Also known as: WRAP
Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH)
PSYRATS-AH is an 11-item subscale assessing frequency, duration, severity, loudness, location, negative content, controllability of voices, intensity of distress, beliefs about origin of voices, and disruption. Items are rated on a five-point ordinal scale (0-4), range is 0 to 44. Higher score means worse distress. PSYRATS has strong inter-rater reliability (r ⩾ 0.9), test-retest reliability (0.55-0.74), and good validity (0.63-0.76). It is the gold standard for assessment of AH and the main finding from the initial VVV pilot study.
Time frame: 12 and 24 weeks
The Sense of Belonging Inventory-Psychological Experiences (SOBI-P)
The SOBI-P is a reliable measure of belonging that consists of 18 items on a 4-point Likert response scale and it is used widely in SSD.
Time frame: 12 and 24 weeks
The Role Functioning Scale (RFS)
This is a distal primary outcome. The Role Functioning Scale (RFS) is a broad global integration index across the domains of work, independent living, and family/social networks that ranges from 1 (worst) to 7 (best). It has established reliability and validity in Schizophrenia Spectrum Disorders. The total score for the RFS is calculated by summing the subscales, resulting in a range of 0-28, where higher scores indicate better functioning.
Time frame: 12 and 24 weeks
Plan to share: Yes — The PI will create de-identified, study-specific datasets that include all variables in a publication. Some loss of information might occur given the need to remove protected health information (PHI). The PI will replace social security and medical station numbers with study-specific numbers. The PI will drop date of birth and replace age with age categories, in accordance with PHI requirements for people 85 years of age and older. Dates of service will be replaced with year dummies.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication.
Access criteria: Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by VA Office of Research and Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Mar 2030, 35 months later.
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 35 months is close to 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.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development →