Families With Substance Use and Psychosis: A Pilot Study

Sponsor

Mclean Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04284813

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arm

21.4

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: CRAFT-FT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 24, 2020

Actual Primary Completion Date :

Aug 25, 2021

Actual Study Completion Date :

Jul 7, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of Sessions Completed [Post-intervention, approximately Week 6-8]
Percentage of sessions completed during the intervention

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

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).