Psychotic DisordersVVVNCT05562674
Impact of VVV Group for Veterans With SMI
A study testing Veteran Voices and Visions in people with Psychotic Disorders and Veterans, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Veterans
- What is being tested?
- Veteran Voices and Visions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM 5 diagnoses of:
- schizophrenia
- schizoaffective disorder
- bipolar with psychosis
- depression with psychosis
- PTSD with psychosis
- unspecified psychosis
Who cannot join
- Substance-induced psychosis,
- clinically significant neurological disease,
- history of serious head injury with loss of consciousness > 1 hour
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
About this study
Official title: Impact of Veteran Voices & Visions Peer Support Groups on Social Integration for Veterans With SMI/Psychosis
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.
Read the 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.
- Conditions
- Psychotic Disorders, Veterans
- Being tested
- Veteran Voices and Visions
- Keywords
- Psychosis, Serious Mental Illness, Veterans, Hearing Voices
- Medical subject headings
- Psychotic Disorders, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veteran Voices and VisionsBehavioural
Clinician and peer co-led meaning-oriented support group based on the Hearing Voices approach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Veteran Voices and Visions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychotic Symptoms Rating Scale (PSYRATS-AH)
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.
Measured: 12 weeks after the initiation of the intervention
Role Functioning Scale Total Score
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.
Measured: 12 weeks after the initiation of the intervention
Secondary outcomes (16)
Beliefs About Voices Questionnaire-R Omnipotence Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire-R Malevolence Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire-R Benevolence Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire-R Resistance Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire-R Emotional Resistance Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire-R Engagement Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire - R Emotional Engagement Subscale
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.
Measured: 12 weeks
Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale
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.
Measured: 12 weeks
Peters Delusion Inventory Count
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.
Measured: 12 weeks
Peters Delusion Inventory Distress Subscale
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.
Measured: 12 weeks
Brief Psychiatric Rating Scale Global Score
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.
Measured: 12 weeks
Questionnaire on the Process of Recovery
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.
Measured: 12 weeks
Generalized Self-Efficacy Scale
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.
Measured: 12 weeks
Internalized Stigma of Mental Illness
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.
Measured: 12 weeks
UCLA Loneliness Scale
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start18 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm trial evaluating the feasibility and acceptability of the manualized protocol the investigators develop.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ippolytos A Kalofonos, MD PhD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562674
- Sponsor's protocol ID
- D4376-P
- Acronym
- VVV
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2022
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Veteran Voices & Visions Peer Support Groups on Social Integration for Veterans With SMI/Psychosis
- ClinicalTrials.gov ID
- NCT05562674
- Acronym / sponsor ID
- VVV / D4376-P
- Conditions
- Psychotic Disorders, Veterans
- Keywords
- Psychosis, Serious Mental Illness, Veterans, Hearing Voices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm trial evaluating the feasibility and acceptability of the manualized protocol the investigators develop.
| Arm | Type | Receives |
|---|---|---|
| Veteran Voices & Visions (VVV) | Experimental | Behavioral: Veteran Voices and VisionsVeteran 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DSM 5 diagnoses of:
Key exclusion criteria (3 listed)
- Substance-induced psychosis,
- clinically significant neurological disease,
- history of serious head injury with loss of consciousness > 1 hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veteran Voices and VisionsClinician and peer co-led meaning-oriented support group based on the Hearing Voices approach. | Behavioural | Veteran Voices & Visions (VVV) |
Primary outcome
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.
16 secondary outcomes
Beliefs About Voices Questionnaire-R Omnipotence Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire-R Malevolence Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire-R Benevolence Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire-R Resistance Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire-R Emotional Resistance Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire-R Engagement Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire - R Emotional Engagement Subscale
Time frame: 12 weeks
Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale
Time frame: 12 weeks
Peters Delusion Inventory Count
Time frame: 12 weeks
Peters Delusion Inventory Distress Subscale
Time frame: 12 weeks
Brief Psychiatric Rating Scale Global Score
Time frame: 12 weeks
Questionnaire on the Process of Recovery
Time frame: 12 weeks
Generalized Self-Efficacy Scale
Time frame: 12 weeks
Internalized Stigma of Mental Illness
Time frame: 12 weeks
UCLA Loneliness Scale
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ippolytos A Kalofonos, MD PhD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veteran Voices and Visions in people with Psychotic Disorders and Veterans, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Psychotic Symptoms Rating Scale (PSYRATS-AH) (time frame: 12 weeks after the initiation of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.