Evaluating a Brief Virtual Cognitive Remediation Therapy Intervention for Those With Early Phase Psychosis and Substance Misuse

Not Applicable

Not yet recruiting

• Conditions: Psychosis; Alcohol Use Disorder; Cannabis Use Disorder

• Registration Number: NCT07056894
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Psychotic disorders affect approximately 4.6 per 1000 people globally, translating to about 1.5 million Canadians. Despite their relatively low prevalence, these disorders have a significant impact due to their onset during youth and emerging adulthood, leading to substantial personal, family, and societal burdens. Economically, the direct costs for care exceed CAN$2 billion in Canada and $18 billion worldwide, with indirect costs such as lost productivity adding another CAN$4.8 billion. Early intervention is critical for improving long-term outcomes and reducing illness burden and costs. Early intervention services target psychosis during the first 2-5 years of illness, focusing on youth and young adult specific care. A major barrier to successful outcomes in these programs is substance misuse. The two most common recreational substances misused in this population are alcohol and cannabis, with approximately 12.5% misusing alcohol, 20.8% misusing cannabis, and 50% misusing both. Both alcohol and cannabis use can affect developing brain structures and functioning in young adults, which can impact cognitive skills such as memory and learning. Additionally, substance use can also overlap with brain changes in early phase psychosis, which can increase psychotic symptoms, reduce medication adherence, and negatively impact social relationships, physical health, and quality of life.

Addressing substance misuse in early phase psychosis is crucial, yet current pharmacological treatments are limited by side effects and acceptability issues. As another option, psychosocial interventions like cognitive remediation therapy, which target cognition and functional outcomes, show promise for reducing substance use. For example, a study found a cognitive remediation therapy focused on improving executive functioning and cognitive control, led to a reduction in alcohol use in chronic schizophrenia. More studies are needed to explore treatment duration, virtual delivery, and retention strategies suitable for early intervention services settings.

The Nova Scotia Early Psychosis Program recently conducted a pilot study with 13 participants indicating that neurocognitive and social-cognitive remediation may reduce alcohol and cannabis misuse in early phase psychosis patients. However, recruitment challenges and lower attendance in later stages suggested that shorter therapy durations may be more effective for young adults. Action-Based Cognitive Remediation offers a concise alternative with 16 sessions over 2 months. This intervention has shown efficacy in the early phase psychosis population and can be delivered in-person, hybrid, or remotely. It combines psychoeducation and computerized cognitive training, with real-world application through simulated tasks and behavioral goal setting. Improvements in cognitive function and social cognition are linked to reductions in substance misuse, especially cannabis, though this has not been specifically studied in early phase psychosis.

Our primary objective is to determine if youth and emerging adults with early phase psychosis and problematic alcohol and/or cannabis use will reduce their consumption after treatment with an Action-Based Cognitive Remediation intervention, compared to patients receiving treatment as usual. Our secondary objectives are to evaluate whether assessing readiness to change at baseline will improve retention to therapy or even predict treatment outcomes (i.e. right therapy at the right time) and assess the feasibility (as initially tested in our pilot study) of virtual delivery of a cognitive remediation therapy to young adults with early phase psychosis living in both rural and urban locations.

Detailed Description

Subjects will be recruited from the provincial Early Psychosis Intervention Nova Scotia programs (with the central site located in Halifax at the Nova Scotia Early Psychosis Program) and the Psychosis Intervention Early Recovery program in St. John's, Newfoundland. This is an open choice clinical trial comparing Action-Based Cognitive Remediation (ABCR) to treatment as usual (TAU) in early phase psychosis subjects. Following screening procedures, the participants will be offered the choice to enroll in the intervention or TAU group. Those who select ABCR will attend 16 bi-weekly therapy sessions over 2 months in a virtual group format. The TAU group will involve involved one brief psychoeducation session on the impacts of substance use in general on recovery.

This study will collect four different types of variables: demographic (things that describe the participants), clinical (things that describe how ill the individuals are), substance use (things that measure how much or how reliant participants are on recreational substances), and neuropsychological (things that measure cognitive functioning such as attention, memory, verbal learning, and executive functioning). These variables will be collected at baseline, 2 months (therapy end), and 3 months post-therapy for both the intervention and TAU group.

Demographic variables: Age, age when joined the early phase psychosis program, sex, gender, and ethnicity will be collected at baseline.

Substance use variables: A contemplation ladder tool focused on alcohol and/or cannabis use will be used at baseline to assess willingness to change substance use to explore if readiness to change influences engagement with treatment and outcomes. The remaining measurements will be used at the three specified time-points. The Cannabis Use Disorder Identification Test - Revised (CUDIT-R) will collect data on hazardous cannabis use. The WHO Alcohol, Smoking and Substance Involvement Screening Test (WHO-ASSIST) will be administered to screen for all substance use including tobacco, as well as alcohol and other recreational and illicit substances. The Timeline Follow-back (TLFB) method will collect detailed information about the last 30 day use of alcohol and/or cannabis. The alcohol use TLFB will collect the number of drinks consumed on each day. The cannabis use TLFB will collect information on cannabis quantity (gm/day), frequency (e.g. daily, times/week), type of product used (e.g. dried flower, concentrates, edibles) and potency (e.g. THC %, THC/CBD). Potency data will be self-report though also explored thru websites used for product purchase. Quantity and frequency will be assisted by visual aids if required. The TLFB has been validated for schizophrenia-spectrum disorders, used in research done by the study team.

Clinical variables: The Positive and Negative Symptom Scale (PANSS) will measure negative and positive psychotic symptom severity. Overall psychosis symptoms will be measured by the Clinical Global Impression scale, for both severity and improvement (CGI-S, CGI-I). The World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0) will measure functioning across cognitive, mobility, self-care, getting along, life activities, and participation domains. The Calgary Depression Scale for Schizophrenia (CDSS) will assess the level of depression, and the Beck Anxiety Inventory (BAI) will examine anxiety symptoms.

Neuropsychological profile: The Digit vigilance test will measure attention during a rapid visual tracking task. The California Verbal Learning Test 3 (CVLT3) will measure episodic verbal learning including verbal learning, immediate memory, and delayed memory. Trail Making Test A (TMT-A) will measure processing speed and the Trail Making Test B (TMT-B) will identify deficits in executive functioning. The Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) will provide a social cognition composite score.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Last Update Submitted: 2025-06-29
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Start: 2025-11-01
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• This study will enroll individuals 16-30 years of age from Early Intervention Services for Psychosis 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)).

Exclusion Criteria

• Current stimulant use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cannabis consumption	Baseline, 2 months, 5 months	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).
Change in problematic cannabis use	Baseline, 2 months, 5 months	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.
Change in alcohol consumption	Baseline, 2 months, 5 months	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).
Change in problematic alcohol use	Baseline, 2 months, 5 months	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.

Secondary Outcome Measures

Name	Time	Method
Readiness to change substance use	Baseline	A contemplation ladder will be used to assess willingness to change alcohol and/or cannabis sue to explore if readiness to change influences engagement with treatment and outcomes.
Change in overall substance use	Baseline, 2 months, 5 months	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.
Change in psychotic symptom severity	Baseline, 2 months, 5 months	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.
Change in severity of illness	Baseline to 5 months	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.
Change in functioning	Baseline, 2 months, 5 months	The World Health Organization Disability Assessment Schedule 2 (WHODAS 2.0) will measure functioning across cognitive, mobility, self-care, getting along, life activities, and participation domains. Total scores range from 40 to 180 with higher scores indicating worse functioning.
Change in depression symptoms	Baseline, 2 months, 5 months	Calgary Depression Scale for Schizophrenia (CDSS) will measure the level of depression based on symptoms seen in people with a schizophrenia spectrum disorder. Total scores range from 0-27 with higher scores indicating more severe depression.
Change in anxiety symptoms	Baseline, 2 months, 5 months	Beck Anxiety Inventory (BAI) will measure anxiety symptoms on a scale of 0-63 with higher scores indicating more severe anxiety.
Change in verbal learning	Baseline, 2 months, 5 months	The California Verbal Learning Test - Third Edition (CVLT3) will be used to measure changes in verbal learning index scores from baseline to 6 months. The CVLT3measures episodic verbal learning including verbal learning, immediate memory, and delayed memory. The CVLT3 yields three index scores of overall verbal learning and memory performance using a mean of 100 and a standard deviation (SD) of 15 points. The scores range from 40-160, which is 4 SDs below and above the mean.
Change in processing speed	Baseline, 2 months, 5 months	Trial Making Test A (TMT-A) will measure processing speed in recorded time taken to complete the task for drawing a line between numbers in order. Recorded test time more than 78 seconds indicates deficits in processing speed.
Change in executive functioning	Baseline, 2 months, 5 months	Trail Making Test B (TMT-B) will be used to measure changes in recorded time taken to complete the task. The assessment requires participant to draw a continuous line between circles containing letters and numbers in the correct ascending sequence (i.e., 1-A-2-B-3-C, etc.). Recorded test time more than 180 seconds indicates deficits in executive functioning.
Change in attention	Baseline, 2 months, 3 months	The digit vigilance test will measure attention during a rapid visual tracking task. Scores are calculated for the total time and total errors.
Change in social cognition	Baseline, 2 months, 3 months	The Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) will provide a social cognition composite score based on four branches of emotional intelligence: perceiving emotions, facilitating thought, understanding emotions, and managing emotions. The average MSCEIT score is 100 with a standard deviation of 115.

Trial Locations

Locations (2)

Psychosis Intervention Early Recovery program; 🇨🇦 Saint John's, Newfoundland and Labrador, Canada

Nova Scotia Early Psychosis Program; 🇨🇦 Halifax, Nova Scotia, Canada