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NCT Number: NCT07555275

Testing a Peer-Support Group for Veterans Who Hear Voices

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veteran Voices and Visions (VVV)

Behavioral

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

Wellness Recovery Action Planning (WRAP)

Behavioral

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

Primary outcomes

  1. Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH)

    Time frame: 12 and 24 weeks

    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.

  2. The Sense of Belonging Inventory-Psychological Experiences (SOBI-P)

    Time frame: 12 and 24 weeks

    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.

  3. The Role Functioning Scale (RFS)

    Time frame: 12 and 24 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erica H Fletcher, PhD

CONTACT

[email protected]

(805) 295-9979

Ippolytos A Kalofonos, MD PhD MPH

CONTACT

[email protected]

(310) 478-3711 ext. 83254

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • VA Pittsburgh Healthcare System

Registry information

Official study title

A Multisited Efficacy Trial of Veteran Voices and Visions

Acronym: VVV RCT

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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