Families With Substance Use and Psychosis: A Pilot Study

NCT04284813 | Completed Results

• 2 other identifiers: 2020P0002201K23DA050808-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Substance Use; Substance Use Disorders; Family; Tobacco Use; Nicotine Use Disorder; Cigarette Smoking; Cannabis; Marijuana; Alcohol Use Disorder; Alcohol; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Mental Disorder

Keywords

Family; Substance Use Disorder; Psychosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Sessions Completed

  Percentage of sessions completed during the intervention

  Post-intervention, approximately Week 6-8

Secondary Outcomes (2)

• Mean Session Satisfaction Rating

  Up to 8 weeks

• Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats

  Up to 8 weeks

Study Arms (1)

Telemedicine

EXPERIMENTAL

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

Interventions

CRAFT-FT BEHAVIORAL

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.

Telemedicine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-70.
• Having a relative who:
• 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
• 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.

You may not qualify if:

• 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.
• 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
• N/A

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

• 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.

  PMID: 10689661 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Substance-Related Disorders; Tobacco Use; Tobacco Use Disorder; Cigarette Smoking; Marijuana Abuse; Alcoholism; Schizophrenia; Bipolar Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Chemically-Induced Disorders; Behavior; Tobacco Smoking; Smoking; Alcohol-Related Disorders; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Julie M. McCarthy, PhD
• Organization: McLean Hospital/Harvard Medical School

jmccarthy@mclean.harvard.edu

6178553521

Study Officials

• Julie McCarthy, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Psychologist

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: September 24, 2020
• Primary Completion: August 25, 2021
• Study Completion: July 7, 2022
• Last Updated: October 12, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)