Families With Substance Use and Psychosis: A Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Tobacco Use; Bipolar Disorder; Cannabis; Substance Use; Substance Use Disorders; Psychosis; Alcohol Use Disorder; Mental Disorder; Cigarette Smoking; Nicotine Use Disorder; Family; Marijuana; Alcohol
• Intervention / Treatment: Behavioral: CRAFT-FT

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: CRAFT-FT; CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Sessions Completed	Percentage of sessions completed during the intervention	Post-intervention, approximately Week 6-8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Session Satisfaction Rating	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.	Up to 8 weeks
Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats	Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Julie McCarthy, PhD, McLean Hospital

Publications and helpful links

General Publications

• Meyers RJ, Miller WR, Hill DE, Tonigan JS. Community reinforcement and family training (CRAFT): engaging unmotivated drug users in treatment. J Subst Abuse. 1998;10(3):291-308. doi: 10.1016/s0899-3289(99)00003-6.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Family; Psychosis; Substance Use Disorder
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Substance-Related Disorders; Alcoholism; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Tobacco Use Disorder; Bipolar Disorder
• Other Study ID Numbers: 2020P000220; 1K23DA050808-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No