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Families With Substance Use and Psychosis: A Pilot Study

Primary Purpose

Psychosis, Substance Use, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRAFT-FT
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Family, Substance Use Disorder, Psychosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telemedicine

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of Sessions Completed
Percentage of sessions completed during the intervention

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 24, 2020
Last Updated
September 16, 2022
Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04284813
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Community Reinforcement and Family Training for first episode psychosis delivered via telemedicine (CRAFT-FT) with 6-8 weekly sessions of 60-minute therapy.
Intervention Type
Behavioral
Intervention Name(s)
CRAFT-FT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Sessions Completed
Description
Percentage of sessions completed during the intervention
Time Frame
Post-intervention, approximately Week 6-8
Secondary Outcome Measure Information:
Title
Mean Session Satisfaction Rating
Description
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.
Time Frame
Up to 8 weeks
Title
Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats
Description
Percentage of participant preference for in-person, telemedicine, or both sessions formats as assessed categorically during the Treatment Satisfaction Interview.
Time Frame
Up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie McCarthy, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10689661
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.
Results Reference
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Families With Substance Use and Psychosis: A Pilot Study

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