Impact of VVV Group for Veterans With SMI

Psychotic Disorders Clinical Trial

— VVV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562674
• Other study ID #: D4376-P
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Ippolytos A Kalofonos, MD PhD MPH
• Phone: (310) 478-3711
• Email: Ippolytos.Kalofonos[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Veterans

Intervention

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.
• Healthy Lifestyles
This will be a group matched with the experimental condition for location, format, degree of interaction, and duration, but with a distinct content, that focuses on nutrition and lifestyle.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Psychotic Symptoms Rating Scale (PSYRATS-AHS)	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.	Twenty weeks after the initiation of the intervention.