Families With Substance Use and Psychosis: A Pilot Study

NCT ID: NCT04284813

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2022-07-07

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemedicine

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

Group Type: EXPERIMENTAL

CRAFT-FT

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

• 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.

• N/A

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Julie McCarthy, Ph.D.

Assistant Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie McCarthy, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10689661 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1K23DA050808-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P000220

Identifier Type: -

Identifier Source: org_study_id