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Impact of VVV Group for Veterans With SMI (VVV)

Primary Purpose

Psychotic Disorders, Veterans

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Support group
Healthy Lifestyles
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Veteran Voices & Visions (VVV)

Healthy Lifestyles

Arm Description

This is the experimental condition, testing the manual the investigators have developed.

This is the control condition, matched for location, format, degree of interaction, and duration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2022
Last Updated
October 5, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05562674
Brief Title
Impact of VVV Group for Veterans With SMI
Acronym
VVV
Official Title
Impact of Veteran Voices & Visions Peer Support Groups on Social Integration for Veterans With SMI/Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized control trial evaluating the feasibility and acceptability of the manualized protocol the investigators develop. The investigators will compare the VVV group with a "Healthy Lifestyles" group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Veteran Voices & Visions (VVV)
Arm Type
Experimental
Arm Description
This is the experimental condition, testing the manual the investigators have developed.
Arm Title
Healthy Lifestyles
Arm Type
Active Comparator
Arm Description
This is the control condition, matched for location, format, degree of interaction, and duration.
Intervention Type
Behavioral
Intervention Name(s)
Support group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyles
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Psychotic Symptoms Rating Scale (PSYRATS-AHS)
Description
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.
Time Frame
Twenty weeks after the initiation of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ippolytos A Kalofonos, MD PhD MPH
Phone
(310) 478-3711
Ext
83254
Email
Ippolytos.Kalofonos@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Sonya E Gabrielian, MD MPH
Phone
(310) 478-3711
Ext
49853
Email
Sonya.Gabrielian@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ippolytos A Kalofonos, MD PhD MPH
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott E Krahl, PhD MA BA
Phone
818-895-5861
Email
scott.krahl@va.gov
First Name & Middle Initial & Last Name & Degree
Ippolytos A Kalofonos, MD PhD MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Impact of VVV Group for Veterans With SMI

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