Families With Substance Use and Psychosis: A Pilot Study

Not Applicable

Completed

• Conditions: Tobacco Use; Cannabis; Alcohol Use Disorder; Schizophrenia; Substance Use; Nicotine Use Disorder; Schizoaffective Disorder; Psychosis; Cigarette Smoking; Substance Use Disorders
• Interventions: Behavioral: CRAFT-FT

• Registration Number: NCT04284813
• Lead Sponsor: Mclean Hospital

Brief Summary

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2020-09-24
• Primary Completion: 2021-08-25
• Study Completion: 2022-07-07
• Results First Submitted: 2022-08-23
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Results First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Ages 18-70.

• Having a relative who:

  1. Is a patient with early course psychosis (DSM-5 schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (NOS), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis) with first onset in the past 6 years, and
  2. Uses tobacco, alcohol, or cannabis in the past 90 days and/or has no apparent immediate interest in abstinence.

• The person(s) who can best describe the client with psychosis.

• At least 4 days per month contact with the client.

• Access to a computer with internet or mobile phone with video conferencing capabilities.

• Ability to provide written informed consent.

• Speak and read English.

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Exclusion Criteria

• DSM-5 moderate or severe substance use disorder in the past year.
• Lifetime psychotic disorder.
• History of domestic violence with the identified patient (IP).
• Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the treatment plan.

Inclusion Criteria for Client Relatives:

• Ages 18-35.

• First episode psychosis (FEP) onset in the past 6 years with a DSM-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non-affective psychosis (schizophrenia spectrum disorder).

  a. Used tobacco, alcohol, or cannabis within the past 90 days and/or has no apparent immediate interest in abstinence.

• Ability to provide written informed consent.

• Speak/read English

Exclusion Criteria:

• N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telemedicine	CRAFT-FT	Community Reinforcement and Family Training for first episode psychosis delivered via telemedicine (CRAFT-FT) with 6-8 weekly sessions of 60-minute therapy.

Primary Outcome Measures

Name	Time	Method
Percentage of Sessions Completed	Post-intervention, approximately Week 6-8	Percentage of sessions completed during the intervention

Secondary Outcome Measures

Name	Time	Method
Mean Session Satisfaction Rating	Up to 8 weeks	Participants will report weekly satisfaction ratings following each session on the Session Survey. Ratings will range from 1 (poor) to 5 (excellent) for overall experience and convenience.
Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats	Up to 8 weeks	Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview.

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States