Testing a Peer-Support Group for Veterans Who Hear Voices (VVV RCT)

A Multisited Efficacy Trial of Veteran Voices and Visions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychotic Disorders; Social Isolation; Hallucinations, Auditory
• Intervention / Treatment: Behavioral: Veteran Voices and Visions (VVV); Behavioral: Wellness Recovery Action Planning (WRAP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ippolytos A Kalofonos, MD PhD MPH; Phone Number: 83254 (310) 478-3711; Email: Ippolytos.Kalofonos@va.gov
• Study Contact Backup: Name: Erica H Fletcher, PhD; Phone Number: (805) 295-9979; Email: Erica.Fletcher@va.gov

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073-1003
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
      • Contact: Ippolytos A Kalofonos, MD PhD MPH; Phone Number: 83254 310-478-3711; Email: Ippolytos.Kalofonos@va.gov
      • Principal Investigator: Ippolytos A Kalofonos, MD PhD MPH
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
      • Contact: Matthew Chinman, PhD; Phone Number: 4287 412-683-2300; Email: chinman@rand.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veteran Voices and Visions (VVV); 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); 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.; Other Names: VVV
Active Comparator: Wellness Recovery Action Planning (WRAP); 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); 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.; Other Names: WRAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: VA Pittsburgh Healthcare System
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 29, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Psychotic Disorders; social isolation; hallucinations, auditory
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Psychotic Disorders; Hallucinations; Social Isolation; Musculoskeletal and Neural Physiological Phenomena; Cell Physiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Nervous System Physiological Phenomena; Ocular Physiological Phenomena; Sensation; Signal Transduction; Light Signal Transduction; Vision, Ocular
• Other Study ID Numbers: RRD4-007-25M; 1I01RD000538-01A2 (Other Grant/Funding Number: VA RRD&T)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No