Clinical trial NCT04284813: Families With Substance Use and Psychosis: A Pilot Study
Official title: Treatment Engagement in Families With Substance Use and Psychosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-02-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

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

Primary outcomes:
measure: Percentage of Sessions Completed
timeFrame: Post-intervention, approximately Week 6-8
Secondary outcomes:
measure: Mean Session Satisfaction Rating
timeFrame: Up to 8 weeks
measure: Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Julie McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.