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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called CRAFT-EP (Community Reinforcement and Family Training for Early Psychosis) to assist families facing early psychosis and substance use issues. The goal is to determine if this program, delivered via video calls, can provide better support than usual treatments. Participants will receive either CRAFT-EP plus standard care or just the usual treatment. It suits family members concerned about a relative's alcohol or cannabis use who have regular contact with them. Participants must be able to use video conferencing and speak English. As an unphased trial, this study offers families a unique opportunity to explore innovative support methods for early psychosis and substance use.

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 prior data suggests that CRAFT-EP is safe for families experiencing early psychosis and substance use?

Research has shown that Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) is generally easy for participants to handle. In a previous study, researchers tested this telehealth method with families facing early psychosis and substance use issues. The study found it to be safe, with no major side effects reported. This suggests that CRAFT-EP can be a safe option for families seeking help with these challenges. While more research is always beneficial, current evidence indicates that participants tolerate this treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CRAFT-EP for psychosis and substance use because it integrates Community Reinforcement and Family Training specifically designed for early psychosis. Unlike traditional treatments, which often focus solely on the patient, CRAFT-EP involves family members in 8 weekly sessions of coaching to create a supportive environment for recovery. This method aims to enhance the effectiveness of standard Treatment as Usual (TAU) by fostering family involvement and reinforcement, potentially leading to better outcomes for both psychosis and substance use issues.

What evidence suggests that CRAFT-EP is effective for early psychosis and substance use?

Research has shown that Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP), which participants in this trial may receive, could assist families dealing with early psychosis and substance use. One study examined a version of CRAFT delivered through telehealth and found it practical and possibly beneficial for these families. This method focuses on enhancing family support and communication, potentially leading to better outcomes for those with early psychosis. By involving family members in treatment, CRAFT-EP aims to reduce substance use and improve mental health. Early results suggest this approach might be effective, but further research is needed to confirm. ^{1 2 3 5 6}

Who Is on the Research Team?

Julie M McCarthy, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05380583

Study Details | NCT05380583 | Community Reinforcement ... The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing early psychosis ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10127150/

Pilot Development and Feasibility of Telehealth Community ... The present study aimed to develop and evaluate a telehealth intervention utilizing CRAFT for families experiencing early psychosis and substance use.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05300633

Community Reinforcement Approach and Family Training ... Community Reinforcement Approach and Family Training for Substance Use in Early Psychosis Intervention (CRAFT-EPI). ClinicalTrials.gov ID NCT05300633.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178122003973

Pilot development and feasibility of telehealth Community ... The present study aimed to develop and evaluate a telehealth intervention utilizing CRAFT for families experiencing early psychosis and substance use.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36030701/

Pilot development and feasibility of telehealth Community ... The present study aimed to develop and evaluate a telehealth intervention utilizing CRAFT for families experiencing early psychosis and substance use.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05380583/community-reinforcement-and-family-training-for-early-psychosis-craft-ep-and-substance-use-a-pilot-study?state=MA&city=Belmont

Community Reinforcement and Family Training for Early ... The purpose of this study is to evaluate Community Reinforcement and Family Training for Early Psychosis (CRAFT-EP) for families experiencing ...