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Completed

NCT Number: NCT05562674

Impact of VVV Group for Veterans With SMI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

West Los Angeles, California, 90073-1003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veteran Voices and Visions

Behavioral

Clinician and peer co-led meaning-oriented support group based on the Hearing Voices approach.

Primary outcomes

  1. 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.

  2. 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

  1. Beliefs About Voices Questionnaire-R Omnipotence Subscale

    Time frame: 12 weeks

    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.

  2. Beliefs About Voices Questionnaire-R Malevolence Subscale

    Time frame: 12 weeks

    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.

  3. Beliefs About Voices Questionnaire-R Benevolence Subscale

    Time frame: 12 weeks

    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.

  4. Beliefs About Voices Questionnaire-R Resistance Subscale

    Time frame: 12 weeks

    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.

  5. Beliefs About Voices Questionnaire-R Emotional Resistance Subscale

    Time frame: 12 weeks

    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.

  6. Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale

    Time frame: 12 weeks

    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.

  7. Beliefs About Voices Questionnaire-R Engagement Subscale

    Time frame: 12 weeks

    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.

  8. Beliefs About Voices Questionnaire - R Emotional Engagement Subscale

    Time frame: 12 weeks

    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.

  9. Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale

    Time frame: 12 weeks

    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.

  10. Peters Delusion Inventory Count

    Time frame: 12 weeks

    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.

  11. Peters Delusion Inventory Distress Subscale

    Time frame: 12 weeks

    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. Brief Psychiatric Rating Scale Global Score

    Time frame: 12 weeks

    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.

  13. Questionnaire on the Process of Recovery

    Time frame: 12 weeks

    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.

  14. Generalized Self-Efficacy Scale

    Time frame: 12 weeks

    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.

  15. Internalized Stigma of Mental Illness

    Time frame: 12 weeks

    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.

  16. UCLA Loneliness Scale

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: VVV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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