Cognitive Remediation for Substance Abuse and Psychosis

Not yet recruiting at 1 trial location

Overseen By Candice E Crocker, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Stimulant use disorder, others

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

Compensation: Varies

Number of Visits: 18

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Action-Based Cognitive Remediation (ABCR) to determine if it can help individuals with early-phase psychosis reduce alcohol and cannabis use. Psychosis can complicate thinking and relationships, and substance misuse can exacerbate these issues. ABCR aims to enhance thinking skills and daily life, with the hope of also reducing substance use. Individuals who have experienced psychosis for less than five years and struggle with alcohol or cannabis may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how ABCR can benefit individuals with early-phase psychosis.

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 Action-Based Cognitive Remediation is safe for patients with early phase psychosis?

Research has shown that Action-Based Cognitive Remediation (ABCR) has been tested in people with early phase psychosis (EPP) and has yielded positive results. In these studies, ABCR was delivered in various formats, such as in person or online, and participants generally responded well. One study found that 83% of participants completed the ABCR program, indicating it is well-received. These trials reported no major safety issues. However, its specific effects on reducing substance use have not been fully studied. Overall, ABCR has shown promise in improving daily functioning and social skills without significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Action-Based Cognitive Remediation (ABCR) because it offers a novel approach to tackling substance abuse in individuals with psychosis. Unlike traditional treatments that focus mainly on standard care and psychoeducation, ABCR specifically targets cognitive processes to help reduce alcohol and cannabis consumption. This method aims to improve cognitive functions, which can enhance a person's ability to make healthier choices and manage their symptoms more effectively. By directly addressing the cognitive deficits often seen in psychosis and substance abuse, ABCR has the potential to improve recovery outcomes significantly.

What evidence suggests that Action-Based Cognitive Remediation might be an effective treatment for reducing alcohol and cannabis use in early phase psychosis?

Research has shown that certain therapies can help reduce alcohol use in people with long-term schizophrenia. In this trial, participants may receive Action-Based Cognitive Remediation (ABCR), which has effectively improved daily life skills and social understanding for those in the early stages of psychosis. Although ABCR hasn't been directly studied for its effects on substance use, its focus on enhancing thinking skills might help reduce alcohol and cannabis use. A pilot study demonstrated that a similar therapy, Cognitive Enhancement Therapy (CET), helped reduce problematic alcohol and cannabis use in early psychosis participants. ABCR is designed to be shorter and more intensive, potentially making it more effective for this group. ^{1 3 6 7 8}

Who Is on the Research Team?

Philip G Tibbo, MD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for young adults in the early stages of psychotic disorders who are struggling with substance misuse, particularly alcohol and cannabis. Participants should be interested in improving their thinking skills and everyday functioning.

Inclusion Criteria

Has problematic alcohol and/or cannabis use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT) or Cannabis Use Disorder Identification Test-Revised (CUDIT-R))

I am 16-30 years old and part of a psychosis early intervention program in Nova Scotia or Newfoundland.

I have been diagnosed with a type of schizophrenia.

Exclusion Criteria

Current stimulant use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Action-Based Cognitive Remediation (ABCR) therapy, consisting of 16 bi-weekly sessions over 2 months in a virtual group format

2 months

16 virtual group sessions

Follow-up

Participants are monitored for changes in substance use and cognitive functioning post-therapy

3 months

Assessments at 2 months and 3 months post-therapy

Long-term Follow-up

Participants are monitored for changes in substance use and psychotic symptoms

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Action-Based Cognitive Remediation

Trial Overview The study tests Action-Based Cognitive Remediation (ABCR), a therapy designed to improve cognitive abilities over 16 sessions within two months. It aims to see if ABCR can help reduce alcohol and/or cannabis use among those with early phase psychosis.

How Is the Trial Designed?

Group I: Action-Based Cognitive Remediation (ABCR) Experimental Treatment 1 Intervention

Action-Based Cognitive Remediation with an aim to reduce alcohol and/or cannabis consumption

Group II: Treatment as Usual Active Control 1 Intervention

Standard early intervention care and one psychoeducation session on the impacts substance use on recovery from psychosis.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Canadian Research Initiative in Substance Misuse

Collaborator

Trials

1

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07056894

Effects of Action-Based Cognitive Remediation on ... Early intervention services have been shown to improve outcomes when provided during the first few years of illness known as early phase psychosis (EPP).

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07056894/effects-of-action-based-cognitive-remediation-on-substance-misuse-in-early-phase-psychosis

Effects of Action-Based Cognitive Remediation on ... ABCR has been tested in the EPP population and has shown positive results when delivered in person, hybrid and remotely. Although this therapy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4837677/

Patterns of Substance Use During Cognitive Enhancement ... Cognitive remediation may be effective for improving some substance use problems in schizophrenia. Visual learning and problem-solving deficits may be ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772598725000285

Piloting of an Intervention to Reduce Problematic Alcohol ... The three participants in the TAU group also saw a decrease in alcohol use, with a 31% reduction in mean alcohol use scores between baseline and ...

5. withpower.com withpower.com/trial/phase-marijuana-abuse-10-2025-aeae9

Cognitive Remediation for Substance Abuse and Psychosis Trial Overview The study tests Action-Based Cognitive Remediation (ABCR), a therapy designed to improve cognitive abilities over 16 sessions within two months.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27100095/

Action-based cognitive remediation for individuals with ... Results: Significantly more ABCR participants (83%) were retained in the intervention compared with tCR (57%) and reported greater increases in perceived ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03814122

Action-based Cognitive Remediation for First Episode ... Also called a data safety and monitoring board, or DSMB. ... These trials gather additional information about a drug's safety, efficacy, or optimal use.

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07910-7

Effect of immersive virtual reality-based cognitive remediation ... We will examine the effect of a 4-week, intensive virtual reality-based cognitive remediation programme involving daily life challenges on cognition and daily ...