Testing a Peer-Support Group for Veterans Who Hear Voices
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has been experiencing auditory hallucinations at least weekly within the past 6 months that are not exclusively due to substance use
English fluency sufficient for participating in groups
Able to provide consent
Disqualifiers
Psychosis exclusively due to substance use
Clinically significant seizure disorder, traumatic brain injury, dementia, developmental disorder/intellectual disability
Inability to provide informed consent for any reason, including due to acute psychosis, mania, or dementia, or active guardianship or durable power of attorney
Plan to transfer or terminate care in the next 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Veteran Voices and Visions (VVV)
BehavioralThis 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 hallucinations, delusions, and social isolation.
Wellness Recovery Action Planning (WRAP)
BehavioralWellness Recovery Action Planning (WRAP) is a peer-led, structured self-management and recovery program designed for serious mental illness delivered in weekly group sessions for 8-12 weeks. It covers personalized wellness strategies, identification of warning signs for re-lapse, and crisis plans. It has improved overall distress due to psychiatric symptoms, quality of life, and hope. A systemic review and meta-analysis concluded WRAP reliably improves subjective recovery outcomes but not symptoms. WRAP is not tailored to psychosis.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Veteran Voices and Visions (VVV)Experimental treatment 1 intervention
Group B: Wellness Recovery Action Planning (WRAP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH)
PSYRATS-AH is an 11-item subscale assessing frequency, duration, severity, loudness, location, negative content, controllability of voices, intensity of distress, beliefs about origin of voices, and disruption. Items are rated on a five-point ordinal scale (0-4), range is 0 to 44. Higher score means worse distress. PSYRATS has strong inter-rater reliability (r ⩾ 0.9), test-retest reliability (0.55-0.74), and good validity (0.63-0.76). It is the gold standard for assessment of AH and the main finding from the initial VVV pilot study.
Time frame
12 and 24 weeks2
The Sense of Belonging Inventory-Psychological Experiences (SOBI-P)
The SOBI-P is a reliable measure of belonging that consists of 18 items on a 4-point Likert response scale and it is used widely in SSD.
Time frame
12 and 24 weeks3
The Role Functioning Scale (RFS)
This is a distal primary outcome. The Role Functioning Scale (RFS) is a broad global integration index across the domains of work, independent living, and family/social networks that ranges from 1 (worst) to 7 (best). It has established reliability and validity in Schizophrenia Spectrum Disorders. The total score for the RFS is calculated by summing the subscales, resulting in a range of 0-28, where higher scores indicate better functioning.
Time frame
12 and 24 weeksSponsors and contacts
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VA Office of Research and Development
Lead sponsor
VA Pittsburgh Healthcare System
Collaborator
Source ClinicalTrials.gov
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