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Clinical Trials/NCT05562674
NCT05562674CompletedNot Applicable

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

VA Office of Research and Development2 sites in 1 country28 target enrollmentStarted: March 18, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
2
Primary Endpoint
The Psychotic Symptoms Rating Scale (PSYRATS-AHS)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Veteran Voices and Visions (Behavioral)

Outcomes

Primary Outcomes

The Psychotic Symptoms Rating Scale (PSYRATS-AHS)

Time Frame: 12 weeks after the initiation of the intervention.

PSYRATS-AHS 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. Range of score is 0-44. The investigators will be assessing for within-subject change. Any decrease in overall score is indicative of decreased distress.

The Psychotic Symptoms Rating Scale (PSYRATS-AH)

Time Frame: 12 weeks after the initiation of the intervention

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.

Role Functioning Scale Total Score

Time Frame: 12 weeks after the initiation of the intervention

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.

Secondary Outcomes

  • Beliefs About Voices Questionnaire-R Omnipotence Subscale(12 weeks)
  • Peters Delusion Inventory Count(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)
  • Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale(12 weeks)
  • Beliefs About Voices Questionnaire-R Engagement Subscale(12 weeks)
  • Beliefs About Voices Questionnaire - R Emotional Engagement Subscale(12 weeks)
  • Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale(12 weeks)
  • Peters Delusion Inventory Distress Subscale(12 weeks)
  • Brief Psychiatric Rating Scale Global Score(12 weeks)
  • Questionnaire on the Process of Recovery(12 weeks)
  • Generalized Self-Efficacy Scale(12 weeks)
  • Internalized Stigma of Mental Illness(12 weeks)
  • UCLA Loneliness Scale(12 weeks)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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