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Clinical Trials/NCT05380583
NCT05380583
Recruiting
N/A

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

Mclean Hospital1 site in 1 country80 target enrollmentMay 19, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosis
Sponsor
Mclean Hospital
Enrollment
80
Locations
1
Primary Endpoint
Family Wellbeing: Depression
Status
Recruiting
Last Updated
6 months ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 19, 2022
End Date
March 30, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie McCarthy, Ph.D.

Assistant Professor of Psychology

Mclean Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Family Wellbeing: Depression

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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