Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT07056894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
Evaluating a Brief Virtual Cognitive Remediation Therapy Intervention for Those With Early Phase Psychosis and Substance Misuse in NS/NL: Addressing Challenges in Underserviced Areas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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, sex, gender, ethnicity, highest education level attained and current employment or education status as well as religious status (observing/not observing/do not identify) will be collected at baseline. Employment and school enrollment will be measured again at the end of the intervention. Relationship and living status will also be collected at baseline and end of the intervention.
Current medications will be recorded as there is some debate on the possible impact of some antipsychotic and antidepressant medications on reducing alcohol and cannabis use. Health resource utilization will include hospitalizations, number of missed clinical appointments with the EIS and emergency room visits for the trial period. All of which can be obtained from the patient's clinician.
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, 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 through websites used for product purchase.
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 (DVT) 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.
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, sex, gender, ethnicity, highest education level attained and current employment or education status as well as religious status (observing/not observing/do not identify) will be collected at baseline. Employment and school enrollment will be measured again at the end of the intervention. Relationship and living status will also be collected at baseline and end of the intervention.
Current medications will be recorded as there is some debate on the possible impact of some antipsychotic and antidepressant medications on reducing alcohol and cannabis use. Health resource utilization will include hospitalizations, number of missed clinical appointments with the EIS and emergency room visits for the trial period. All of which can be obtained from the patient's clinician.
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, 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 through websites used for product purchase.
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 (DVT) 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: