Impact of VVV Group for Veterans With SMI

NCT05562674 | Completed Results

• 1 other identifier: D4376-P
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans with Serious Mental Illness (SMI) struggle with social integration - participation in work, housing, and citizenship - due to symptoms, stigma, and psychosocial challenges. Despite considerable VA efforts to provide mental health care to Veterans with SMI, programs that promote social integration are lacking. Veterans with SMI are at especially high risk for poor social integration and suicidal ideation during the COVID-19 pandemic. This project addresses this need with a group-based, peer specialist (PS) co-facilitated psychosocial intervention for Veterans with SMI, called "Veteran Voices and Visions" (VVV). VVV targets Veterans with SMI who experience psychosis, a group particularly in need of support with social integration. Virtual VVV groups are co-led by VA mental health clinicians (MHCs) and PSs via online video conference. The approach facilitates group cohesion around and normalization of the common psychotic symptoms of SMI: hallucinations, delusions, and social isolation. This intervention has the potential to create and foster a supportive community that improves the social integration of participants by reducing their distress and self-stigma, and increasing self-efficacy.

Conditions

Psychotic Disorders; Veterans

Keywords

Psychosis; Serious Mental Illness; Veterans; Hearing Voices

Outcome Measures

Primary Outcomes (2)

• The Psychotic Symptoms Rating Scale (PSYRATS-AH)

  PSYRATS-AH is an 11-item scale which assesses the frequency, duration, severity, loudness, location, negative content, and controllability of voices, intensity of distress, and beliefs about origin of voices and disruptiveness. Minimum score is 0, maximum 44. Any decrease in overall score is indicative of decreased distress.

  12 weeks after the initiation of the intervention

• Role Functioning Scale Total Score

  The Role Functioning Scale (RFS) is a broad global integration index across the 4 domains: work, independent living, and family relationships and immediate social network relationships. Each domain ranges from 1 (worst) to 7 (best), for a total score range of minimum 4, maximum 28.

  12 weeks after the initiation of the intervention

Secondary Outcomes (16)

• Beliefs About Voices Questionnaire-R Omnipotence Subscale

  12 weeks

• Beliefs About Voices Questionnaire-R Malevolence Subscale

  12 weeks

• Beliefs About Voices Questionnaire-R Benevolence Subscale

  12 weeks

• Beliefs About Voices Questionnaire-R Resistance Subscale

  12 weeks

• Beliefs About Voices Questionnaire-R Emotional Resistance Subscale

  12 weeks

Study Arms (1)

Veteran Voices & Visions (VVV)

EXPERIMENTAL

Veteran Voices and Visions is the experimental condition. It is a group of Veterans who are experiencing chronic psychosis. The group meets for 60 minutes, weekly, for 12 weeks. The investigators adapted a manual and protocol for the VA and this study is testing this manual. This is a single-arm study.

Behavioral: Veteran Voices and Visions

Interventions

Veteran Voices and Visions BEHAVIORAL

Clinician and peer co-led meaning-oriented support group based on the Hearing Voices approach.

Veteran Voices & Visions (VVV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM 5 diagnoses of:
• schizophrenia
• schizoaffective disorder
• bipolar with psychosis
• depression with psychosis
• PTSD with psychosis
• unspecified psychosis

You may not qualify if:

• Substance-induced psychosis,
• clinically significant neurological disease,
• history of serious head injury with loss of consciousness \> 1 hour

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Hallucinations

Interventions

Vision, Ocular

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Results Point of Contact

• Title: Ippolytos Kalofonos
• Organization: Greater Los Angeles VA Health System

ikalofonos@mednet.ucla.edu

510-219-3615

Study Officials

• Ippolytos A Kalofonos, MD PhD MPH

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a single arm trial evaluating the feasibility and acceptability of the manualized protocol the investigators develop.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 3, 2022
• Study Start: March 18, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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 ORD. Those requesting data will be asked to sign a Letter of Agreement.

Locations

US (1)