Testing a Peer-Support Group for Veterans Who Hear Voices
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Veteran Voices and Visions (VVV), Wellness Recovery Action Planning (WRAP).
- Кому может быть актуально
- Состояния в реестре: Psychotic Disorders, Hallucinations, Auditory, Social Isolation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Multisited Efficacy Trial of Veteran Voices and Visions
Обзор
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.
Подробное описание
Veterans have a higher prevalence than non-Veterans of Schizophrenia-spectrum disorders (SSD). These Veterans often struggle with social integration-e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. They are at high risk of homelessness and suicide, and the impact on overall mortality is comparable to that of smoking and greater than obesity and alcohol abuse. SSD diagnoses are a significant cause of disability and a drain on VA resources. Auditory hallucinations (AH) are particularly linked to social withdrawal. Stigma against voice-hearing leads to silence, internalized shame, and social isolation, fueling cycles of avoidance and distress. Veteran Voices and Visions (VVV) is a psychosocial group intervention for Veterans with psychosis based on the Hearing Voices (HV) approach that reduces distress related to psychosis and builds a sense of belonging for Veterans living with psychosis. This intervention is hypothesized to increase social integration.
VVV takes a recovery-oriented, peer-led, Veteran-centered approach to understanding and reframing psychosis that emphasizes personal meaning and destigmatization. Pilot data indicates the approach reduces distress due to AH and fosters a sense of belonging. Research with Veterans with Serious Mental Illness (SMI) shows a high sense of belonging is protective against suicidal ideation. The proposed study would be the first ever to test the efficacy of a HV-inspired approach. If successful, it could transform how VA addresses psychosis by mobilizing the peer workforce to the benefit of a vulnerable group of Veterans.
Specific Aims: Aim 1: Assess VVV efficacy: At each site, 80 Veterans will be randomly assigned to receive 12 weeks of VVV or a Wellness Recovery Action Planning (WRAP) group. Facilitators will be regularly supervised, and group sessions will be video recorded for fidelity review. Veterans will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks) on the proximal outcomes of distress related to AH and sense of belonging, and distal outcome of social functioning. Secondary outcomes include severity of symptoms, self-efficacy, subjective recovery, self-stigma, loneliness, and hope.
Hypothesis: Veterans in VVV will have reduced distress due to AH and increased sense of belonging relative to Veterans in WRAP at the end of the intervention, and they will have increased social functioning at 24-week follow up.
Aim 2: Identify contextual factors that support or impede VVV implementation in the context of routine care. The investigators will use the updated Consolidation Framework for Implementation Research (CFIR) to guide interviews with VVV facilitators, and local and national mental health leadership. The investigators will use rapid analysis on the resulting qualitative data to assess the context to support implementation of VVV (if effective).
Methodology: This is a 4-year hybrid 1 efficacy trial comparing VVV and WRAP across 2 VA sites.
Path to Translation/Implementation: A hybrid 1 trial is when an intervention is tested for effectiveness while collecting implementation data that could inform future delivery in real-world settings. Adding implementation assessments is a modest investment that does not impede the full test of an intervention's effectiveness and speeds the pace of the research pipeline, which often moves evidence-based practices (EBPs) into real-world settings much too slowly. The next step could be an implementation-focused trial.
Вмешательства
- Поведенческое Veteran Voices and Visions (VVV)
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 hallucinations, delusions, and social isolation. - Поведенческое Wellness Recovery Action Planning (WRAP)
Wellness 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 sympto
Первичные конечные точки
- Psychotic Symptom Rating Scale for Auditory Hallucinations (PSYRATS-AH) [Срок оценки: 12 and 24 weeks]
- The Sense of Belonging Inventory-Psychological Experiences (SOBI-P) [Срок оценки: 12 and 24 weeks]
- The Role Functioning Scale (RFS) [Срок оценки: 12 and 24 weeks]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
- Has previously attended a VVV group
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 2 центра
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh
Идентификаторы
NCT: NCT07555275 · RRD4-007-25M · 1I01RD000538-01A2