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CRAFT-EP for Psychosis and Substance Use

N/A

Recruiting

Led By Julie M McCarthy, PhD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 4 days per month contact with the client

Be older than 18 years old

Must not have

Family members with lifetime psychotic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid-intervention (week 4), post-intervention (week 8)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether CRAFT-EP, a treatment for families experiencing early psychosis and substance use, is effective when delivered over video conferencing.

Who is the study for?

This trial is for individuals aged 18-70 who have used alcohol or cannabis in the past month, are not currently interested in quitting substance use, and have experienced early psychosis within the last six years. Family members concerned about their relative's substance use can participate if they speak English, can consent, and have video conferencing tools.

What is being tested?

The study is testing a program called CRAFT-EP delivered via telehealth to help families dealing with early psychosis and substance use. It compares this approach with typical support methods (TAU) to see which is more effective when conducted through video calls.

What are the potential side effects?

Since this trial involves family training and support rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional or psychological discomfort during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I interact with the client at least 4 days a month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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A family member has a lifelong psychotic disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid-intervention (week 4), post-intervention (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid-intervention (week 4), post-intervention (week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-intervention (week 4), post-intervention (week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean readiness to change substance use

Secondary study objectives

Family Wellbeing: Anxiety

Family Wellbeing: Depression

Family Wellbeing: Relationship

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CRAFT-EP + TAUExperimental Treatment2 Interventions

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

Group II: Treatment as UsualActive Control1 Intervention

Treatment as Usual

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAU

2013

Completed Phase 3

~8300

0 / 2Eligibility criteria met