Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis

NCT07056894 | Not Yet Recruiting

• 1 other identifier: 74209
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected. The age of onset for psychotic disorders often begin during the critical years of youth and early adulthood, resulting in significant challenges for individuals and their families, including difficulties with thinking, relationships, and overall well-being. They also carry significant economic costs, both for health care and lost productivity. Early intervention services have been shown to improve outcomes when provided during the first few years of illness known as early phase psychosis (EPP). However, substance use, especially alcohol and cannabis, can interfere with the effectiveness of these services. Many young people with psychosis misuse these substances, which can harm brain development, worsen symptoms, reduce medication use, and lower quality of life. Despite understanding the risks, there are few effective ways to reduce substance misuse in patients with EPP. One promising approach to reducing substance misuse in this population is cognitive remediation therapy, which helps improve thinking skills and everyday functioning. Studies have found that some cognitive remediation therapies can help reduce alcohol use in chronic schizophrenia, but there is limited research targeting the EPP population. Our research team at the Nova Scotia Early Psychosis Program recently completed a pilot study that indicated a therapy called Cognitive Enhancement Therapy (CET) helped participants reduce their problematic alcohol and cannabis use. However, challenges with recruitment and lower attendance rates noted towards the end of the 6-month therapy course suggests that patients with EPP would benefit more from a therapy with a shorter timeframe. Alternatively, Action-Based Cognitive Remediation (ABCR) targets the same cognitive domains believed to help reduce substance use as CET, but has a shorter, more concise schedule. ABCR cover 16 sessions delivered bi-weekly for 2 months, compared to 45 sessions over 6 months of CET. ABCR has been tested in the EPP population and has shown positive results when delivered in person, hybrid and remotely. Although this therapy is demonstrating benefits for patients including improvement in daily functioning and social cognition, its effects on substance misuse have not been researched. This study aims to investigate whether treatment with ABCR helps patients with EPP reduce their alcohol and/or cannabis use.

Conditions

Psychosis; Alcohol Use Disorder; Cannabis Use Disorder

Keywords

alcohol; cannabis; action based cognitive remediation; psychosis

Outcome Measures

Primary Outcomes (4)

• Change in cannabis consumption

  Cannabis Timeline Followback (TLFB) is a retrospective past 30 day calendar method used to collect detailed information about current cannabis use, which includes quantity, method of use (e.g. dried cannabis smoked, concentrate vaped, edibles, etc.), frequency, strain, and potency (e.g., THC %, THC/CBD).

  Baseline, 2 months, 5 months

• Change in problematic cannabis use

  Cannabis Use Disorder Identification Test - Revised (CUDIT-R) will be used to measure problematic cannabis use scores on a scale of 0-32 with higher scores indicating more problematic use.

  Baseline, 2 months, 5 months

• Change in alcohol consumption

  Alcohol Timeline Followback (TLFB) is a retrospective 30 day calendar method used to collected the number of drinks consumed on each day of the past month. Changes in alcohol consumption will be measured (mL per day).

  Baseline, 2 months, 5 months

• Change in problematic alcohol use

  Alcohol Use Disorder Identification Test (AUDIT) will be used to measure problematic alcohol use on a scale of 0-40 with higher scores indicating more problematic use.

  Baseline, 2 months, 5 months

Secondary Outcomes (12)

• Readiness to change substance use

  Baseline

• Change in overall substance use

  Baseline, 2 months, 5 months

• Change in psychotic symptom severity

  Baseline, 2 months, 5 months

• Change in severity of illness

  Baseline to 5 months

• Change in functioning

  Baseline, 2 months, 5 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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

Action-Based Cognitive Remediation (ABCR)

EXPERIMENTAL

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

Behavioral: Action-Based Cognitive Remediation

Interventions

Action-Based Cognitive Remediation BEHAVIORAL

ABCR is a 16 session intervention involving computer-based drills, real-life simulations, and therapist-facilitated discussions intended to promote cognitive strategy monitoring and transfer of cognitive strategies to daily life. The sessions cover the follow key topics: Speed \& Attention, Memory, Executive Functioning, and Social Cognition.

Action-Based Cognitive Remediation (ABCR)

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• This study will enroll individuals 16-30 years of age from the Early Intervention Services for Psychosis programs in Nova Scotia and the Psychosis Intervention Early Recovery program in Newfoundland
• Diagnosed with a primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder)
• Less than 5 years of psychotic illness
• 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)).

You may not qualify if:

• Current stimulant use disorder

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Canadian Research Initiative in Substance Misuse: collaborator

Study Sites (2)

Psychosis Intervention Early Recovery program

St. John's, Newfoundland and Labrador, Canada

Location

Nova Scotia Early Psychosis Program

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Psychotic Disorders; Alcoholism; Marijuana Abuse

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Philip G Tibbo, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Church, MSc. OT

CONTACT

902-473-7474; rachel.church@nshealth.ca

Candice E Crocker, PhD

CONTACT

902-473-3755; candice.crocker@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 50 participants will choose either treatment as usual in an Early Intervention for Psychosis Service (EIS with 1 hour of psychoeducation or EIS plus Action-Based Cognitive Remediation for alcohol/cannabis misuse.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)