SchizophreniaORBITNCT05731414
Outcomes From Remediation and Behavioural Intervention Techniques
A study testing Cognitive Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR) and Befriending in people with Schizophrenia and Psychosis, run by University of Toronto at 2 sites in Canada.
Trial summary
It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychosis, Psychotic Disorders
- What is being tested?
- Cognitive Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR) and Befriending
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Mar 2023to 31 Jan 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Diagnosed with schizophrenia-spectrum disorders
- Can read, write, and speak English
Who cannot join
- Neurodevelopmental disability or neurocognitive disorder
- CBT or CR in the past 6 months
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
University of Toronto Scarborough
Scarborough Village, Ontario, M1C 1A4
Michael W Best, PhD, 6476896098 ext. 1, m.best@utoronto.ca
Michael W Best, PhD
- Recruiting
Ontario Shores Centre for Mental Health Sciences (Ontario Shores)
Whitby, Ontario, L1N 5S9
About this study
Official title: Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.
Read the detailed description
Dominant treatment approaches for schizophrenia-spectrum disorders improve psychiatric symptoms but do little to improve community functioning, leading to persistent disability and substantial economic burden. The proposed trial aims to examine the efficacy of a multi-mechanism approach to combining CBT and CR with the goal of predicting treatment response to either monotherapy or combination therapy. To date, there have been no randomized controlled trials examining the combination of CBT and CR. Given the differential mechanisms of CBT and CR, the combined multi-mechanism approach is expected to more effectively improve functional recovery than either monotherapy. Additionally, it is currently unknown what factors predict response to CBT or CR, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy. The proposed trial will be one of the largest trials of psychosocial interventions for schizophrenia-spectrum disorders ever conducted and will simultaneously evaluate the combined intervention and moderators of differential treatment response. Narrower fields of inquiry examining mono-mechanism interventions have demonstrated little utility in improving functional recovery in schizophrenia, thus, the proposed approach represents a critical advancement by examining the utility of a multi-mechanism cognitive intervention and determining characteristics of those requiring this level of treatment.
The goals of the current study are three-fold:
- Examine the efficacy of combining CBT and CR on the primary outcome of community functioning, and secondary outcomes of quality of life, personal recovery, psychiatric symptoms, and neurocognition compared to either intervention alone.
- Examine demographic, cognitive, and psychological factors that predict differential response to CBT, CR, or combined CBT and CR.
- Examine the specificity of cognitive content and cognitive functions as therapeutic mechanisms in CBT and CR respectively.
- Being tested
- Cognitive Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR), Befriending, Sham Cognitive Remediation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for Psychosis (CBTp)Behavioural
Individual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness. This approach has demonstrated moderate to large improvements on symptoms and small to moderate effects on functioning. The first four sessions are devoted to building therapeutic rapport and developing collaborative treatment goals. The following phase focuses on developing formulations of why difficulties persist and using cognitive and behavioural change strategies. A longitudinal formulation is then offered to better understand how their difficulties developed. The final 2-4 sessions focus on consolidating the learning that occurred during treatment so that participants can maintain their improvement. Therapy homework is collaboratively assigned at the end of sessions to promote new learning in between sessions.
Cognitive Remediation Therapy (CR)Behavioural
Action-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials. ABCR involves practicing computerized training exercises with difficulty level dynamically titrated to improve neurocognitive abilities. Then participants engage in strategy discussions with other group members to develop new cognitive strategies. Finally, participants complete role-play simulations of real-world activities to practice their cognitive strategies in simulations of everyday life. ABCR is more effective for improving functioning than traditional approaches to CR. Homework consists of additional cognitive training and practicing cognitive strategies in everyday life.
BefriendingBehavioural
Befriending will be delivered according to a manual validated to control for the non-specific effects of CBT, such as duration of therapeutic contact, client expectancy effects, therapeutic alliance, and therapist warmth. Befriending consists of 1-hour individual sessions once per week and involves a series of conversations similar to those one might have with a social acquaintance. These conversations involve discussion of neutral topics without problem-solving, coping strategies, or exploration of emotion. If emotional or mental health-related topics are brought up therapists redirect back to a neutral topic.
Sham Cognitive RemediationBehavioural
Sham CR was developed by Dr. Best and Dr. Bowie (CI) to control for the non-specific effects of CR such as computer practice and group discussion. Participants practice similar computerized exercises to ABCR, however, the exercises do not increase in difficulty. Participants then discuss enjoyment of the exercises but any discussion of cognitive strategies is redirected back to a neutral topic. We have previously found this condition to be an effective control for CR, with similar engagement to the active training group.
| Study group | Role | What they receive |
|---|---|---|
| Individual CBTp + Group Sham CR | Experimental | Individual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness.
Sham CR was developed by Dr. Best and Dr. Bowie (CI) to control for the non-specific effects of CR such as computer practice and group discussion. Receives: Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp); Behavioral: Sham Cognitive Remediation |
| Group CR + Individual Befriending (Sham CBTp) | Experimental | Action-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials.
Befriending will be delivered according to a manual validated to control for the non-specific effects of CBT, such as duration of therapeutic contact, client expectancy effects, therapeutic alliance, and therapist warmth. Receives: Behavioral: Cognitive Remediation Therapy (CR); Behavioral: Befriending |
| Individual CBTp + Group CR | Experimental | Individual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness.
Action-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials. Receives: Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp); Behavioral: Cognitive Remediation Therapy (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning Scale (SFS)
The Social Functioning Scale (SFS) is an interview-based measure assessing basic social adjustment skills. It can be administered to both the participant and informants. Seven aspects are evaluated: (1) social engagement/withdrawal (with raw scores ranging from 0-15); (2) interpersonal behavior (with raw scores ranging from 0-9); (3) pro-social activities (with scores ranging from 0-66); (4) recreation (with scores ranging from 0-45); (5) independence-competence (with scores ranging from 0-39); (6) independence-performance (scores ranging from 0-39); and (7) employment/occupation (with scores ranging from 0-10). The lowest total score would be a 0 while the highest would be a 223. Higher scores are indicative of better social functioning.
Measured: Change between baseline assessment and 18-month assessment
Secondary outcomes (12)
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
The WHOQOL-BREF is a 26-item self-report measure assessing quality of life. The four domains included are: (1) physical health, (2) psychological, (3) social relationships and (4) environment. Responses are rated on a 5-point scale, and reverse-scored items are included. The highest total raw score would be a 130, while the lowest would be a 26. Higher scores indicate better quality of life.
Measured: Change between baseline assessment and 18-month assessment
Questionnaire About the Process of Recovery (QPR)
QPR is a self-report measure assessing recovery with people experiencing psychosis. This version contains 22 items while the response to each statement is scored on a 5-point Likert scale ranging from "0 = strongly disagree" to "4 = strongly agree". The lowest possible score is 0 and the highest score could be 88. Higher scores would indicate better recovery.
Measured: Change between baseline assessment and 18-month assessment
Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item semi-structured interview assessing positive, negative symptoms and general psychopathology. Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, 7 = extreme). The lowest score would be a 30 and the highest score would be 210. A higher score would indicate increased symptomology. A 15-point change on the PANSS is associated with clinically meaningful change.
Measured: Change between baseline assessment and 18-month assessment
Psychotic Symptom Rating Scale (PSYRATS)
The PSYRATS assesses frequency and distress associated with the experiences of auditory hallucinations and delusions based on the PANSS interview. Each of the 17 items is scored on a 5-point scale, where a score of 0 indicates no presence, and 4 indicates the highest severity. The lowest score would be a 0 and the highest score would be 68. A higher score would indicate increased symptomology.
Measured: Change between baseline assessment and 18-month assessment
Neurocognitive Assessment
Neurocognition will be assessed using a cognitive batter that assess the MATRICS cognitive domains. Assessments include Oral Trail Making Test, Hopkins Verbal Learning Test, Letter Number Span, WMS Symbol Span, Brief Visuospatial Memory Test, DKEFS Verbal Fluency, Hinting Task, CNS Vital Signs Symbol Digit Coding, CNS Nonverbal Reasoning, CNS 4-part CPT. A Neurocognitive Composite score will be calculated based on these subtests. Z-scores will range between -3.00 and +3.00, with higher scores indicating better performance.
Measured: Change between baseline assessment and 18-month assessment
Beliefs About Paranoia Scale (BAPS)
The BAPS is a 31-item self-report measure assessing metacognitive beliefs about paranoia. The degree of agreement to each statement is scored on a 4-point scale (1 = not at all, 2 = somewhat, 3 = moderately so, 4 = very much). Scales include positive, negative and normalizing beliefs about paranoia, and paranoia as a survival strategy. The lowest score would be 31 and the highest score would be 124. Higher scores are indicative of more beliefs and are shown to be related to paranoid ideation.
Measured: Change between baseline assessment and 18-month assessment
Interpretations of Voices Inventory (IVI)
The IVI is a 26-item self-report measure assessing perceptions of auditory hallucinations. Meta-physical beliefs about voices, positive beliefs about voices, and beliefs about loss of control are evaluated. Responses are rated on a 4-point scale (1 = Not at all, 2 = Somewhat, 3 = Moderately so, 4 = Very much). The lowest score would be a 26 while the highest score would be a 104. Higher scores are indicative of more and stronger beliefs.
Measured: Change between baseline assessment and 18-month assessment
Brief Core Schema Scale (BCSS)
The BCSS is a 24-item self-report measure assessing positive and negative judgments individuals hold about themselves and others. Responses are first given dichotomously as "no" or "yes". "No" is scored as 0 and if the answers are "yes", the intensity of beliefs are then rated on a 4-point scale (1 = believe it slightly, 2 = believe it moderately, 3 = believe it very much, 4 = believe it totally). The lowest score would be a 0 and the highest score would be a 96. Higher scores in the positive-self subscale indicate more positive beliefs about selves, while higher scores in the negative-self subscale indicate more negative beliefs about selves. Higher scores in the positive-others subscale indicate more positive beliefs about others, while higher scores in the negative-others subscale indicate more negative beliefs about others.
Measured: Change between baseline assessment and 18-month assessment
Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)
The rating format for the 80 Dysfunctional Attitudes Scale items is a 7-point Likert scale ranging from totally agree to totally disagree. Possible responses are scored from 1 to 7, with the direction depending on whether agreement or disagreement with a particular belief is judged to be a maladaptive response, and with higher scores indicating more distorted thinking.
Measured: Change between baseline assessment and 18-month assessment
Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P)
The TiC-P measures direct and indirect costs of health conditions.
The first part contains 21 questions assessing healthcare costs, calculated by multiplying numbers of access with prices.
The second part contains 12 questions assessing productivity losses. For paid work, productivity losses due to absence are measured by cost prices, with the number of workdays multiplying hours per day and a standard hourly rate. Scores on short-term absence are adjusted with long-term absence to avoid double-counting, while the friction period and measurement times are considered for scores on long-term absence. Productivity losses due to presenteeism are calculated by multiplying the number of workdays impaired with (1 - efficiency score/10) and hours per workday. Unpaid productivity losses are calculated by multiplying the days missed by the number of hours per day needed to make up the work, and a standard hourly rate.
Higher scores indicate higher costs related to health conditions.
Measured: Change between baseline assessment and 18-month assessment
Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)
The SSTICS is a 21-item self-report measure assessing subjective cognitive complaints among patients with Schizophrenia. Frequency of experiencing each item is rated on a 5-point scale, ranging from "0 = Never" to "4 = Very Often". The lowest score would be a 0 and the highest score would be an 84. Higher scores are indicative of more subjective cognitive difficulties.
Measured: Change between baseline assessment and 18-month assessment
Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)
DACOBS is a 42-item self-report inventory assessing cognitive processing biases associated with psychosis. The degree of agreement to each statement is scored on a 7-point Likert scale, ranging from "1 = strongly disagree" to "7 = strongly agree". The lowest score would be a 42 and the highest score would be a 294. Higher scores would indicate more cognitive biases.
Measured: Change between baseline assessment and 18 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Mar 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive a) individual CBT + group sham CR, b) group CR + individual Befriending, or c) individual CBT + group CR. Block, cohort randomization will be coordinated by the trial manager at the central site (UTSC), with stratification by treatment site. Cohorts of 5 participants will be randomized to one of the 3 treatment conditions in randomized block sizes of 4, 8, or 12 using a pre-specified randomization list.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Shores Centre for Mental Health Sciences, Queen's University, Centre for Addiction and Mental Health, University of British Columbia
- Responsible party
- Principal investigator, Michael Best, University of Toronto
- Investigators
- Michael W Best, PhD, C.Psych, Principal investigator, University of Toronto Scarborough
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731414
- Sponsor's protocol ID
- 43817
- Acronym
- ORBIT
- Status last verified
- Aug 2024
- First submitted
- 19 Jan 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
- ClinicalTrials.gov ID
- NCT05731414
- Acronym / sponsor ID
- ORBIT / 43817
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Ontario Shores Centre for Mental Health Sciences, Queen's University, Centre for Addiction and Mental Health, University of British Columbia
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Feb 2023 (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.
It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.
Detailed description
Dominant treatment approaches for schizophrenia-spectrum disorders improve psychiatric symptoms but do little to improve community functioning, leading to persistent disability and substantial economic burden. The proposed trial aims to examine the efficacy of a multi-mechanism approach to combining CBT and CR with the goal of predicting treatment response to either monotherapy or combination therapy. To date, there have been no randomized controlled trials examining the combination of CBT and CR. Given the differential mechanisms of CBT and CR, the combined multi-mechanism approach is expected to more effectively improve functional recovery than either monotherapy. Additionally, it is currently unknown what factors predict response to CBT or CR, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy. The proposed trial will be one of the largest trials of psychosocial interventions for schizophrenia-spectrum disorders ever conducted and will simultaneously evaluate the combined intervention and moderators of differential treatment response. Narrower fields of inquiry examining mono-mechanism interventions have demonstrated little utility in improving functional recovery in schizophrenia, thus, the proposed approach represents a critical advancement by examining the utility of a multi-mechanism cognitive intervention and determining characteristics of those requiring this level of treatment.
The goals of the current study are three-fold:
- Examine the efficacy of combining CBT and CR on the primary outcome of community functioning, and secondary outcomes of quality of life, personal recovery, psychiatric symptoms, and neurocognition compared to either intervention alone.
- Examine demographic, cognitive, and psychological factors that predict differential response to CBT, CR, or combined CBT and CR.
- Examine the specificity of cognitive content and cognitive functions as therapeutic mechanisms in CBT and CR respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to receive a) individual CBT + group sham CR, b) group CR + individual Befriending, or c) individual CBT + group CR. Block, cohort randomization will be coordinated by the trial manager at the central site (UTSC), with stratification by treatment site. Cohorts of 5 participants will be randomized to one of the 3 treatment conditions in randomized block sizes of 4, 8, or 12 using a pre-specified randomization list.
| Arm | Type | Receives |
|---|---|---|
| Individual CBTp + Group Sham CR | Experimental | Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp), Behavioral: Sham Cognitive RemediationIndividual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness. Sham CR was developed by Dr. Best and Dr. Bowie (CI) to control for the non-specific effects of CR such as computer practice and group discussion. |
| Group CR + Individual Befriending (Sham CBTp) | Experimental | Behavioral: Cognitive Remediation Therapy (CR), Behavioral: BefriendingAction-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials. Befriending will be delivered according to a manual validated to control for the non-specific effects of CBT, such as duration of therapeutic contact, client expectancy effects, therapeutic alliance, and therapist warmth. |
| Individual CBTp + Group CR | Experimental | Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp), Behavioral: Cognitive Remediation Therapy (CR)Individual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness. Action-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years
- Diagnosed with schizophrenia-spectrum disorders
- Can read, write, and speak English
Key exclusion criteria (2 listed)
- Neurodevelopmental disability or neurocognitive disorder
- CBT or CR in the past 6 months
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 |
|---|---|---|
| Cognitive Behavioural Therapy for Psychosis (CBTp)Individual formulation-based CBT will be delivered for one hour per week using a manual that has been validated in over 1000 individuals with schizophrenia-spectrum disorders across all stages of illness. This approach has demonstrated moderate to large improvements on symptoms and small to moderate effects on functioning. The first four sessions are devoted to building therapeutic rapport and developing collaborative treatment goals. The following phase focuses on developing formulations of why difficulties persist and using cognitive and behavioural change strategies. A longitudinal formulation is then offered to better understand how their difficulties developed. The final 2-4 sessions focus on consolidating the learning that occurred during treatment so that participants can maintain their improvement. Therapy homework is collaboratively assigned at the end of sessions to promote new learning in between sessions. | Behavioural | Individual CBTp + Group CR, Individual CBTp + Group Sham CR |
| Cognitive Remediation Therapy (CR)Action-based cognitive remediation (ABCR) will be delivered in group sessions one hour per week. ABCR was developed by Dr. Bowie (CI) and Dr. Best (PI) and has been found efficacious for schizophrenia-spectrum disorders in three clinical trials. ABCR involves practicing computerized training exercises with difficulty level dynamically titrated to improve neurocognitive abilities. Then participants engage in strategy discussions with other group members to develop new cognitive strategies. Finally, participants complete role-play simulations of real-world activities to practice their cognitive strategies in simulations of everyday life. ABCR is more effective for improving functioning than traditional approaches to CR. Homework consists of additional cognitive training and practicing cognitive strategies in everyday life. | Behavioural | Group CR + Individual Befriending (Sham CBTp), Individual CBTp + Group CR |
| BefriendingBefriending will be delivered according to a manual validated to control for the non-specific effects of CBT, such as duration of therapeutic contact, client expectancy effects, therapeutic alliance, and therapist warmth. Befriending consists of 1-hour individual sessions once per week and involves a series of conversations similar to those one might have with a social acquaintance. These conversations involve discussion of neutral topics without problem-solving, coping strategies, or exploration of emotion. If emotional or mental health-related topics are brought up therapists redirect back to a neutral topic. | Behavioural | Group CR + Individual Befriending (Sham CBTp) |
| Sham Cognitive RemediationSham CR was developed by Dr. Best and Dr. Bowie (CI) to control for the non-specific effects of CR such as computer practice and group discussion. Participants practice similar computerized exercises to ABCR, however, the exercises do not increase in difficulty. Participants then discuss enjoyment of the exercises but any discussion of cognitive strategies is redirected back to a neutral topic. We have previously found this condition to be an effective control for CR, with similar engagement to the active training group. | Behavioural | Individual CBTp + Group Sham CR |
Primary outcome
Social Functioning Scale (SFS)
Time frame: Change between baseline assessment and 18-month assessment
The Social Functioning Scale (SFS) is an interview-based measure assessing basic social adjustment skills. It can be administered to both the participant and informants. Seven aspects are evaluated: (1) social engagement/withdrawal (with raw scores ranging from 0-15); (2) interpersonal behavior (with raw scores ranging from 0-9); (3) pro-social activities (with scores ranging from 0-66); (4) recreation (with scores ranging from 0-45); (5) independence-competence (with scores ranging from 0-39); (6) independence-performance (scores ranging from 0-39); and (7) employment/occupation (with scores ranging from 0-10). The lowest total score would be a 0 while the highest would be a 223. Higher scores are indicative of better social functioning.
12 secondary outcomes
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time frame: Change between baseline assessment and 18-month assessment
Questionnaire About the Process of Recovery (QPR)
Time frame: Change between baseline assessment and 18-month assessment
Positive and Negative Syndrome Scale (PANSS)
Time frame: Change between baseline assessment and 18-month assessment
Psychotic Symptom Rating Scale (PSYRATS)
Time frame: Change between baseline assessment and 18-month assessment
Neurocognitive Assessment
Time frame: Change between baseline assessment and 18-month assessment
Beliefs About Paranoia Scale (BAPS)
Time frame: Change between baseline assessment and 18-month assessment
Interpretations of Voices Inventory (IVI)
Time frame: Change between baseline assessment and 18-month assessment
Brief Core Schema Scale (BCSS)
Time frame: Change between baseline assessment and 18-month assessment
Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)
Time frame: Change between baseline assessment and 18-month assessment
Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P)
Time frame: Change between baseline assessment and 18-month assessment
Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)
Time frame: Change between baseline assessment and 18-month assessment
Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)
Time frame: Change between baseline assessment and 18 month assessment
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 19 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Michael W Best, PhD, C.Psych principal investigator
University of Toronto Scarborough
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR) and Befriending in people with Schizophrenia and Psychosis, run by University of Toronto 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 3 inclusion and 2 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 19 Aug 2025. 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 Hanna Hamzai, HBSc (6476896098 ext. 105, hanna.hamzai@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Functioning Scale (SFS) (time frame: Change between baseline assessment and 18-month assessment). 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 19 Aug 2025.