Impact of VVV Group for Veterans With SMI

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05562674

Collaborator

(none)

Enrollment

Location

Arm

14.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Veterans	Behavioral: Support group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a within-subjects trial evaluating the feasibility and acceptability of the manualized protocol we develop.This is a within-subjects trial evaluating the feasibility and acceptability of the manualized protocol we develop.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 3, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pilot Groups This is a pilot study assessing for feasibility and acceptability of the protocol we develop. There is no control.	Behavioral: Support group 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 SMI: hallucinations, delusions, and social isolation.

Arm

Intervention/Treatment

Experimental: Pilot Groups

This is a pilot study assessing for feasibility and acceptability of the protocol we develop. There is no control.

Behavioral: Support group

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 SMI: hallucinations, delusions, and social isolation.

Outcome Measures

Primary Outcome Measures

The Psychotic Symptoms Rating Scale (PSYRATS-AHS) [Twenty 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. We will be assessing for within-subject change. Any decrease in overall score is indicative of decreased distress.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

DSM 5 diagnoses of schizophrenia, schizoaffective disorder, bipolar with psychosis, depression with psychosis, unspecified psychosis

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT05562674

Other Study ID Numbers:

D4376-P

First Posted:

Oct 3, 2022

Last Update Posted:

Oct 3, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Mental Disorders

Psychotic Disorders

Study Results

No Results Posted as of Oct 3, 2022