CRAFT-EP for Psychosis and Substance Use

Overseen By Julie M McCarthy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Disqualifiers: Moderate substance use disorder, Psychotic disorder, Domestic violence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis and substance use delivered exclusively or primarily via telehealth (video conferencing).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CRAFT-EP for psychosis and substance use?

The study on telehealth CRAFT-EP for early psychosis and substance use showed that participants completed all sessions and rated the program satisfaction as excellent for nearly all sessions, indicating it is feasible and well-received. Additionally, CRAFT has been effective in engaging individuals with alcohol dependence in treatment, suggesting its potential usefulness in similar contexts. ^{1 2 3 4 5}

Is CRAFT-EP safe for humans?

The study on CRAFT-EP for early psychosis and substance use showed that participants completed all sessions and reported high satisfaction, suggesting it is safe and well-received. ^{1 2 3 4 6}

How is the CRAFT-EP treatment different from other treatments for psychosis and substance use?

CRAFT-EP is unique because it adapts the Community Reinforcement and Family Training approach specifically for early psychosis and substance use, focusing on family involvement and delivered via telehealth, which is not commonly used in standard treatments for these conditions. ^{1 3 7 8 9}

Research Team

Julie M McCarthy, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

This trial is for individuals aged 18-70 who have used alcohol or cannabis in the past month, are not currently interested in quitting substance use, and have experienced early psychosis within the last six years. Family members concerned about their relative's substance use can participate if they speak English, can consent, and have video conferencing tools.

Inclusion Criteria

A family member has used alcohol or cannabis recently and isn't interested in stopping.

Person(s) who can best describe the client with psychosis

Family member has concerns about the relative's substance use

Exclusion Criteria

Family members with DSM-5 moderate or severe substance use disorder in the past year

Prior participation of a family member of the client in the study program

Significant prior experience with CRAFT

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CRAFT-EP
• TAU

Trial Overview The study is testing a program called CRAFT-EP delivered via telehealth to help families dealing with early psychosis and substance use. It compares this approach with typical support methods (TAU) to see which is more effective when conducted through video calls.

Participant Groups

Group I: CRAFT-EP + TAU Experimental Treatment 2 Interventions

Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) with 8 weekly sessions of 60-90-minute coaching + Treatment as Usual (TAU).

Group II: Treatment as Usual Active Control 1 Intervention

Treatment as Usual

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The Community Reinforcement and Family Training (CRAFT) approach significantly increased treatment engagement rates for alcohol-dependent individuals (40.5% in the immediate intervention group compared to 13.9% in the waitlist group) at the 3-month follow-up.

Both groups of concerned significant others (CSOs) reported improvements in mental health and family cohesion after receiving the CRAFT intervention, indicating its effectiveness in enhancing the well-being of CSOs regardless of the timing of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Community Reinforcement and Family Training for concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized controlled trial. Bischof, G., Iwen, J., Freyer-Adam, J., et al.[2019]

In a study involving 198 first-episode psychosis patients aged 15-28, five years of sustained specialist treatment (ST) and the addition of parent groups (ST + P) did not significantly improve the time to first relapse or reduce the first relapse rate compared to treatment as usual (TAU).

While there were no significant differences in overall relapse rates, there was a trend suggesting that the addition of parent groups may lead to fewer relapses per patient, indicating a potential benefit worth further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained specialized and family treatment in first-episode schizophrenia or related disorders: a 5-year randomized controlled trial. de Haan, L., Linszen, D., Wouters, L., et al.[2023]

The CRAFT-EP telehealth intervention, designed for families dealing with early psychosis and substance use, showed excellent feasibility with 100% session completion and high satisfaction ratings (99%) among participants.

Participants found communication strategies particularly helpful and expressed a preference for a hybrid or virtual format, indicating that CRAFT-EP could be a valuable tool for future randomized controlled trials in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot development and feasibility of telehealth Community Reinforcement and Family Training (CRAFT) for early psychosis and substance use. McCarthy, JM., Wood, AJ., Shinners, MG., et al.[2023]

The Graduated Recovery Intervention Program (GRIP) was found to be well-tolerated and feasible for individuals with first episode psychosis, as shown by good attendance and low dropout rates among the 46 participants.

While the overall results were not statistically significant, there were indications that GRIP may improve functional outcomes compared to treatment as usual (TAU), suggesting it could be a promising intervention for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot investigation of the Graduated Recovery Intervention Program (GRIP) for first episode psychosis. Penn, DL., Uzenoff, SR., Perkins, D., et al.[2021]

This systematic review and meta-analysis aims to evaluate the safety and efficacy of Acceptance and Commitment Therapy (ACT) specifically for treating schizophrenia spectrum and other psychotic disorders, addressing a gap in current research.

The review will include randomized controlled trials and will assess both short-term and long-term effects of ACT, using a comprehensive search across multiple databases to ensure a thorough evaluation of available evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Acceptance and Commitment Therapy (ACT) in Schizophrenia Spectrum and Other Psychotic Disorders: Protocol for a Systematic Review and Meta-Analysis. Gray, R., Hillel, SA., Brown, E., et al.[2020]

In a pilot study involving 24 individuals with early psychosis, adherence-coping-education (ACE) therapy was well tolerated and led to significant reductions in psychotic and depressive symptoms after 14 sessions.

ACE therapy also showed trend-level improvements in participants' attitudes toward their treatment, indicating its potential to support recovery in individuals experiencing their first psychotic episode.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary trial of adherence-coping-education (ACE) therapy for early psychosis. Uzenoff, SR., Perkins, DO., Hamer, RM., et al.[2021]

A 3-year study involving 39 participants in a weekly outpatient group intervention combining motivational interviewing and cognitive behavior therapy showed significant reductions in substance use and improvements in overall functioning and symptomatology among individuals with psychosis.

Higher attendance in the group sessions (averaging 45.5 sessions) was linked to a greater reduction in the use of acute mental health services, suggesting that longer participation may help prevent relapse and reduce emergency service needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group intervention for coexisting psychosis and substance use disorders in rural Australia: outcomes over 3 years. Bradley, AC., Baker, A., Lewin, TJ.[2019]

In a pilot study involving 25 in-patients aged 18-35 with early psychosis and substance misuse, those receiving the Start Over and Survive (SOS) intervention showed a greater reduction in substance use at 6 months (100% of SOS participants vs. 58% in Standard Care).

The positive effects of the SOS intervention were maintained up to 12 months, although challenges in participant engagement were noted, with 39% declining to participate in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief motivational intervention for substance misuse in recent-onset psychosis. Kavanagh, DJ., Young, R., White, A., et al.[2007]

Family support is crucial in Early Psychosis Intervention (EPI) programs, but its implementation is low due to varying family needs and preferences regarding intervention timing, length, and content, as highlighted in a review of 7 studies.

To improve family support uptake, flexible and tiered approaches to care are recommended, as many families may not need the intensive psychoeducational programs typically offered. More research is needed to determine the effectiveness of these varied support models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementing family support and education in Early Psychosis Intervention programmes: A systematic review. Selick, A., Durbin, J., Vu, N., et al.[2018]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of the Community Reinforcement and Family Training for concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Sustained specialized and family treatment in first-episode schizophrenia or related disorders: a 5-year randomized controlled trial. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Pilot development and feasibility of telehealth Community Reinforcement and Family Training (CRAFT) for early psychosis and substance use. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot investigation of the Graduated Recovery Intervention Program (GRIP) for first episode psychosis. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Acceptance and Commitment Therapy (ACT) in Schizophrenia Spectrum and Other Psychotic Disorders: Protocol for a Systematic Review and Meta-Analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A preliminary trial of adherence-coping-education (ACE) therapy for early psychosis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Group intervention for coexisting psychosis and substance use disorders in rural Australia: outcomes over 3 years. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

A brief motivational intervention for substance misuse in recent-onset psychosis. [2007]

9. Australia pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to implementing family support and education in Early Psychosis Intervention programmes: A systematic review. [2018]