Testing a Peer-Support Group for Veterans Who Hear Voices
VVV RCT
A Multisited Efficacy Trial of Veteran Voices and Visions
2 other identifiers
interventional
160
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2027
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
April 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2030
Study Completion
Last participant's last visit for all outcomes
September 30, 2030
April 29, 2026
April 1, 2026
3 years
April 21, 2026
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
12 and 24 weeks
Study Arms (2)
Veteran Voices and Visions (VVV)
EXPERIMENTALThis 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.
Wellness Recovery Action Planning (WRAP)
ACTIVE COMPARATORWellness 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Has been experiencing auditory hallucinations at least weekly within the past 6 months that are not exclusively due to substance use
- English fluency sufficient for participating in groups
- Able to provide consent
You may not qualify if:
- Psychosis exclusively due to substance use
- Clinically significant seizure disorder, traumatic brain injury, dementia, developmental disorder/intellectual disability
- Inability to provide informed consent for any reason, including due to acute psychosis, mania, or dementia, or active guardianship or durable power of attorney
- Plan to transfer or terminate care in the next 3 months
- Has previously attended a VVV group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ippolytos A Kalofonos, MD PhD MPH
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- PRINCIPAL INVESTIGATOR
Matthew J Chinman, PhD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Although participants and care providers will know to which condition participants have been assigned, research assistants responsible for all assessments will be blinded to study group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2026
First Posted
April 29, 2026
Study Start (Estimated)
April 1, 2027
Primary Completion (Estimated)
March 29, 2030
Study Completion (Estimated)
September 30, 2030
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.