PsychosisNCT07056894
Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis
A study testing Action-Based Cognitive Remediation in people with Psychosis and Alcohol Use Disorder, run by Nova Scotia Health Authority at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Psychosis, Alcohol Use Disorder, Cannabis Use Disorder
- What is being tested?
- Action-Based Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Mar 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)).
Who cannot join
- Current stimulant use disorder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Nova Scotia Early Psychosis Program
Halifax, Nova Scotia
Candice E Crocker, PhD, 902-473-3755, candice.crocker@nshealth.ca
- Recruiting
Psychosis Intervention Early Recovery program
St. John's, Newfoundland and Labrador
Kellie LeDrew, MD, (709) 777-3534, Kellie.Ledrew@nlhealthservices.ca
About this study
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
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.
Read the 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.
- Conditions
- Psychosis, Alcohol Use Disorder, Cannabis Use Disorder
- Being tested
- Action-Based Cognitive Remediation
- Keywords
- alcohol, cannabis, action based cognitive remediation, psychosis
- Medical subject headings
- Psychotic Disorders, Alcoholism, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action-Based Cognitive RemediationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Action-Based Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 2 months, 5 months
Secondary outcomes (12)
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.
Measured: Baseline
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.
Measured: Baseline, 2 months, 5 months
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.
Measured: Baseline, 2 months, 5 months
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.
Measured: Baseline to 5 months
Change in functioning
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.
Measured: Baseline, 2 months, 5 months
Change in depression symptoms
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.
Measured: Baseline, 2 months, 5 months
Change in anxiety symptoms
Beck Anxiety Inventory (BAI) will measure anxiety symptoms on a scale of 0-63 with higher scores indicating more severe anxiety.
Measured: Baseline, 2 months, 5 months
Change in verbal learning
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 CVLT3 measures 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.
Measured: Baseline, 2 months, 5 months
Change in processing speed
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.
Measured: Baseline, 2 months, 5 months
Change in executive functioning
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.
Measured: Baseline, 2 months, 5 months
Change in attention
The digit vigilance test will measure attention during a rapid visual tracking task. Scores are calculated for the total time and total errors.
Measured: Baseline, 2 months, 3 months
Change in social cognition
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.
Measured: Baseline, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start27 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Research Initiative in Substance Misuse
- Responsible party
- Principal investigator, Phil Tibbo, Nova Scotia Health Authority
- Investigators
- Philip G Tibbo, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056894
- Sponsor's protocol ID
- 74209
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared between the Nova Scotia and Newfoundland sites. Data sharing was not a requirement of the study's funding, and given the small sample size, there is a heightened risk of re-identification of participants. To protect participant confidentiality and adhere to institutional ethics guidelines, data will remain securely stored and will not be made available to external parties.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07056894
- Acronym / sponsor ID
- 74209
- Conditions
- Psychosis, Alcohol Use Disorder, Cannabis Use Disorder
- Keywords
- alcohol, cannabis, action based cognitive remediation, psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Canadian Research Initiative in Substance Misuse
- Study start
- 27 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Action-Based Cognitive RemediationAction-Based Cognitive Remediation with an aim to reduce alcohol and/or cannabis consumption |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)).
Key exclusion criteria (1 listed)
- Current stimulant use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action-Based Cognitive RemediationABCR 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. | Behavioural | Action-Based Cognitive Remediation (ABCR) |
Primary outcome
Change in cannabis consumption
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
12 secondary outcomes
Readiness to change substance use
Time frame: Baseline
Change in overall substance use
Time frame: Baseline, 2 months, 5 months
Change in psychotic symptom severity
Time frame: Baseline, 2 months, 5 months
Change in severity of illness
Time frame: Baseline to 5 months
Change in functioning
Time frame: Baseline, 2 months, 5 months
Change in depression symptoms
Time frame: Baseline, 2 months, 5 months
Change in anxiety symptoms
Time frame: Baseline, 2 months, 5 months
Change in verbal learning
Time frame: Baseline, 2 months, 5 months
Change in processing speed
Time frame: Baseline, 2 months, 5 months
Change in executive functioning
Time frame: Baseline, 2 months, 5 months
Change in attention
Time frame: Baseline, 2 months, 3 months
Change in social cognition
Time frame: Baseline, 2 months, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. IPD will only be shared between the Nova Scotia and Newfoundland sites. Data sharing was not a requirement of the study's funding, and given the small sample size, there is a heightened risk of re-identification of participants. To protect participant confidentiality and adhere to institutional ethics guidelines, data will remain securely stored and will not be made available to external parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip G Tibbo, MD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action-Based Cognitive Remediation in people with Psychosis and Alcohol Use Disorder, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Church, MSc. OT (902-473-7474, rachel.church@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cannabis consumption (time frame: Baseline, 2 months, 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.