N/A
N=21
Families With Substance Use and Psychosis: A Pilot Study
Psychosis · Substance Use · Substance Use Disorders · Family · Tobacco Use
Bottom Line
View on ClinicalTrials.gov: NCT04284813 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Oct 2022
Primary outcome: Primary: Percentage of Sessions Completed — 100 percentage of intervention sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CRAFT-FT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Sessions Completed |
100 | — |
| SECONDARY Mean Session Satisfaction Rating |
4.9 | — |
| SECONDARY Percentage of Participant Preference for In-person, Telemedicine, or Both Session Formats |
1; 9; 10 | — |
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:
- 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
Data sourced from ClinicalTrials.gov (NCT04284813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.