跳至主要内容
临床试验/NCT05562674
NCT05562674已完成不适用

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
The Psychotic Symptoms Rating Scale (PSYRATS-AHS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM 5 diagnoses of:
  • schizophrenia
  • schizoaffective disorder
  • bipolar with psychosis
  • depression with psychosis
  • PTSD with psychosis
  • unspecified psychosis

排除标准

  • Substance-induced psychosis,
  • clinically significant neurological disease,
  • history of serious head injury with loss of consciousness > 1 hour

研究组 & 干预措施

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.

干预措施: Veteran Voices and Visions (Behavioral)

结局指标

主要结局

The Psychotic Symptoms Rating Scale (PSYRATS-AHS)

时间窗: 12 weeks after the initiation of the intervention.

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.

The Psychotic Symptoms Rating Scale (PSYRATS-AH)

时间窗: 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

时间窗: 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.

次要结局

  • Beliefs About Voices Questionnaire-R Omnipotence Subscale(12 weeks)
  • Peters Delusion Inventory Count(12 weeks)
  • Beliefs About Voices Questionnaire-R Malevolence Subscale(12 weeks)
  • Beliefs About Voices Questionnaire-R Benevolence Subscale(12 weeks)
  • Beliefs About Voices Questionnaire-R Resistance Subscale(12 weeks)
  • Beliefs About Voices Questionnaire-R Emotional Resistance Subscale(12 weeks)
  • Beliefs About Voices Questionnaire-R Behavioral Resistance Subscale(12 weeks)
  • Beliefs About Voices Questionnaire-R Engagement Subscale(12 weeks)
  • Beliefs About Voices Questionnaire - R Emotional Engagement Subscale(12 weeks)
  • Beliefs About Voices Questionnaire - R Behavioral Engagement Subscale(12 weeks)
  • Peters Delusion Inventory Distress Subscale(12 weeks)
  • Brief Psychiatric Rating Scale Global Score(12 weeks)
  • Questionnaire on the Process of Recovery(12 weeks)
  • Generalized Self-Efficacy Scale(12 weeks)
  • Internalized Stigma of Mental Illness(12 weeks)
  • UCLA Loneliness Scale(12 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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