跳至主要内容
临床试验/NCT05380583
NCT05380583招募中不适用

Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study

Mclean Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Family Wellbeing: Depression

研究概览

简要总结

The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis and substance use delivered exclusively or primarily via telehealth (video conferencing).

详细描述

The intervention aims to improve treatment engagement, substance use patterns, and family wellbeing. To assess preliminary outcomes of the intervention, this study compares CRAFT-EP plus treatment as usual (TAU) compared to TAU alone. Family members will be randomized to CRAFT-EP + TAU or TAU alone. Data on family members and clients with psychosis will be collected for assessment purposes; if a client with psychosis does not have a family member participating in the study, the client with psychosis will be automatically be assigned to the TAU alone group. Total target enrollment is 40 family members and 40 clients with psychosis. Given that family members may participate without a corresponding client with psychosis due to fear of disclosing their participation in the study to the client or client lack of interest, and because the intervention works directly with family members and indirectly with clients, data collected from clients with or without a corresponding family member participating in the study will be hypothesis generating.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Treatment as Usual

Active Comparator

Treatment as Usual

干预措施: TAU (Behavioral)

CRAFT-EP + TAU

Experimental

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).

干预措施: TAU (Behavioral)

结局指标

主要结局

Family Wellbeing: Depression

时间窗: Baseline, mid-intervention (week 4), post-intervention (week 8)

Beck Depression Inventory-II total; scores range from 0 to 63 with higher scores representing more severe depressive symptoms.

次要结局

  • Family Wellbeing: Relationship(Baseline, mid-intervention (week 4), post-intervention (week 8))
  • Family Wellbeing: Anxiety(Baseline, mid-intervention (week 4), post-intervention (week 8))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie McCarthy, Ph.D.

Assistant Professor of Psychology

Mclean Hospital

研究点 (2)

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