Families With Substance Use and Psychosis: A Pilot Study

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284813
• Other study ID #: 2020P000220
• Secondary ID: 1K23DA050808-01
• Status: Completed
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: July 7, 2022

Study information

• Verified date: September 2022
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 7, 2022
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol
• Alcohol Use Disorder
• Alcoholism
• Bipolar Disorder
• Cannabis
• Cigarette Smoking
• Disease
• Family
• Marijuana
• Mental Disorder
• Mental Disorders
• Nicotine Use Disorder
• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders
• Tobacco Use
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Sessions Completed	Percentage of sessions completed during the intervention	Post-intervention, approximately Week 6-8
Secondary	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
Secondary	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