Impact of VVV Group for Veterans With SMI (VVV)

Impact of Veteran Voices & Visions Peer Support Groups on Social Integration for Veterans With SMI/Psychosis

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Veterans
• Intervention / Treatment: Behavioral: Veteran Voices and Visions

Detailed Description

This is a single arm study of feasibility and acceptability of the adapted manual and protocol we have developed in preparation for a larger efficacy trial.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073-1003
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• DSM 5 diagnoses of:

  • schizophrenia
  • schizoaffective disorder
  • bipolar with psychosis
  • depression with psychosis
  • PTSD with psychosis
  • unspecified psychosis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veteran Voices & Visions (VVV); 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; Clinician and peer co-led meaning-oriented support group based on the Hearing Voices approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beliefs About Voices Questionnaire-R Omnipotence Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The omnipotence subscale measures the amount of omnipotence the subjects attributes to their voice. Minimum score is 0, maximum is 18, higher score indicates greater omnipotence.	12 weeks
Beliefs About Voices Questionnaire-R Malevolence Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The malevolence subscale measures the amount of malevolence the subjects attribute to their voice. Minimum score is 0, maximum is 18, higher score indicates greater malevolence.	12 weeks
Beliefs About Voices Questionnaire-R Benevolence Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The benevolence subscale measures the amount of benevolence the subjects attribute to their voice. Minimum score is 0, maximum is 18, higher score indicates greater benevolence.	12 weeks
Beliefs About Voices Questionnaire-R Resistance Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The resistance subscale measures the degree to which the subject willingly engages with their voices. Minimum score is 0, maximum is 18, higher score indicates greater resistance and less engagement.	12 weeks
Beliefs About Voices Questionnaire-R Emotional Resistance Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The emotional resistance subscale measures the degree to which the subject willingly engages with their voices emotionally. Minimum score is 0, maximum 12, higher score indicates greater resistance and less engagement.	12 weeks
Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The behavioral resistance subscale measures the degree to which the subject willingly engages with their voices behaviorally. Minimum score is 0, maximum is 15, higher score indicates greater resistance and less engagement.	12 weeks
Beliefs About Voices Questionnaire-R Engagement Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The engagement subscale measures the degree to which the subject willingly engages with their voices. Minimum score is 0, maximum 27, higher score indicates greater engagement.	12 weeks
Beliefs About Voices Questionnaire - R Emotional Engagement Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The emotional engagement subscale measures the degree to which the subject willingly engages with their voices emotionally. Minimum score is 0, maximum 15, higher score indicates greater engagement.	12 weeks
Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale	The Revised Beliefs About Voices Questionnaire (BAVQ-R) is a measure of a person's beliefs, emotions and behavior in response to voices. The 35-item questionnaire forms five sub-scales: three concerning beliefs about the dominant voice (malevolence, benevolence and omnipotence), and two concerning emotional and behavioral reactions (resistance, and engagement). The behavioral engagement subscale measures the degree to which the subject willingly engages with their voices behaviorally. Minimum score is 0, maximum is 12, Higher score indicates greater engagement.	12 weeks
Peters Delusion Inventory Count	The Peters Delusion Inventory is a 21-item measure of distress, preoccupation, and conviction of delusions with high convergent, discriminant, and criterion validity. Minimum score is 0, maximum is 21. Higher score indicates worse outcome.	12 weeks
Peters Delusion Inventory Distress Subscale	The Peters Delusion Inventory is a 21-item measure of distress, preoccupation, and conviction of delusions with high convergent, discriminant, and criterion validity. Minimum score is 0, maximum is 60. Higher score indicates worse outcome. The distress subscale measures the amount of cumulative distress associated with all reported delusions.	12 weeks
Brief Psychiatric Rating Scale Global Score	Assesses for psychiatric symptoms-specifically the positive/negative symptom assess subscale scores and suicidal ideation. Minimum score is 24, maximum is 168. Higher score indicates worse outcome.	12 weeks
Questionnaire on the Process of Recovery	The Questionnaire on the Process of Recovery (QPR) is an instrument co-developed by service users and re-searchers about recovery from psychosis with 15 items measuring connectedness, hope, identity, meaning, and empowerment. The QPR has demonstrated high internal and convergent validity as well as sensitivity to change. Minimum score is 0, maximum is 60. Higher score indicates better outcome.	12 weeks
Generalized Self-Efficacy Scale	Generalized Self-Efficacy Scale is a 10-item measure of self-efficacy that has been shown to be valid and reliable and has been used with schizophrenia. Range, 10-40. Higher score indicates better outcome.	12 weeks
Internalized Stigma of Mental Illness	The Internalized Stigma of Mental Illness scale is a 29-item measure of internalized stigma with five subscales (alienation, stereotype endorsement, discrimination, experience, social withdrawal, and stigma resistance). It has been used with schizophrenia and is reliable (a = .90) and valid. Range, 1-4, as all item scores are averaged. Higher score indicates worse outcome.	12 weeks
UCLA Loneliness Scale	UCLA Loneliness Scale, a 20-item scale measuring subjective experience of loneliness, is considered the gold standard measure of perceived social isolation and is highly reliable (a = .89-.94) and valid. It has been used with SSD. Range, 20-80. Higher score indicates worse outcome.	12 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ippolytos A Kalofonos, MD PhD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Psychosis; Veterans; Serious Mental Illness; Hearing Voices
• 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; Signs and Symptoms; Psychotic Disorders; Hallucinations; 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: D4376-P

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 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 ORD. Those requesting data will be asked to sign a Letter of Agreement.

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