Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-30
SponsorNova Scotia Health Authority
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)).
Disqualifiers
Current stimulant use disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Action-Based Cognitive Remediation
BehavioralABCR 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Treatment as UsualNo intervention 0 interventions
Group B: Action-Based Cognitive Remediation (ABCR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, 2 months, 5 months2
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.
Time frame
Baseline, 2 months, 5 months3
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).
Time frame
Baseline, 2 months, 5 months4
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.
Time frame
Baseline, 2 months, 5 monthsSecondary outcomes
1
Readiness to change substance use
A contemplation ladder will be used to assess willingness to change alcohol and/or cannabis use to explore if readiness to change influences engagement with treatment and outcomes.
Time frame
Baseline2
Change in overall substance use
The WHO Alcohol, Smoking, and Substance Involvement Screening Test (WHO-ASSIST) will measure substance use risk scores to account for problematic use other than cannabis use. Scores range from 0-39 for each substance with higher scores indicating more severe risk associated with use.
Time frame
Baseline, 2 months, 5 months3
Change in psychotic symptom severity
The Positive and Negative Symptom Scale (PANSS) will measure psychotic symptom severity across positive, negative and general domains. Positive and negative symptomatology score both range from 7 to 49, and a general psychopathology score range from 16 to 112, with a total score range from 30 to 210. Higher scores indicate higher severity of symptoms.
Time frame
Baseline, 2 months, 5 months4
Change in severity of illness
Clinical Global Impression Scale - Severity (CGI-S) at baseline and then the complementary scale for follow-up the Clinical Global Impression Scale - Improvement (CGI-I) will measure changes from baseline in participants overall illness severity at 5 months, The CGI-S, a 7-point clinician rated Likert scale that measures individuals' overall illness severity relative those who the clinician has experienced with the same diagnosis (ranging from 1 = Normal, not at all ill to 7 = Extremely ill). The CGI-I is based on the CGI-S rating and is a 7-point clinician rated Likert scale ranging from 1 = Very much improved to 7 = Very much worse.
Time frame
Baseline to 5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Canadian Research Initiative in Substance Misuse
Collaborator
Source ClinicalTrials.gov