Outcomes From Remediation and Behavioural Intervention Techniques (ORBIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Schizophrenia; Psychosis; Schizophrenia; Psychosis
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp); Behavioral: Sham Cognitive Remediation; Behavioral: Cognitive Remediation Therapy (CR); Behavioral: Befriending

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:

1. 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.
2. Examine demographic, cognitive, and psychological factors that predict differential response to CBT, CR, or combined CBT and CR.
3. Examine the specificity of cognitive content and cognitive functions as therapeutic mechanisms in CBT and CR respectively.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna Hamzai, HBSc; Phone Number: 105 6476896098; Email: hanna.hamzai@mail.utoronto.ca
• Study Contact Backup: Name: Mike W Best, PhD, C.Psych; Phone Number: 6476014551; Email: m.best@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Scarborough, Ontario, Canada, M1C 1A4
      • Recruiting
      • University of Toronto Scarborough
      • Contact: Michael W Best, PhD; Phone Number: 1 6476896098; Email: m.best@utoronto.ca
      • Principal Investigator: Michael W Best, PhD
    • Whitby, Ontario, Canada, L1N 5S9
      • Recruiting
      • Ontario Shores Centre for Mental Health Sciences (Ontario Shores)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18-65 years
• Diagnosed with schizophrenia-spectrum disorders
• Can read, write, and speak English

Exclusion Criteria:

• Neurodevelopmental disability or neurocognitive disorder
• CBT or CR in the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual CBTp + Group Sham 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. 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.	Behavioral: 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.; Behavioral: Sham Cognitive Remediation; 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.
Experimental: Group CR + Individual Befriending (Sham CBTp); 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.	Behavioral: 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.; Behavioral: Befriending; 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.
Experimental: Individual CBTp + Group 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.	Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change between baseline assessment and 18-month assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Change between baseline assessment and 18-month assessment

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: University of British Columbia; Centre for Addiction and Mental Health; Queen's University; Ontario Shores Centre for Mental Health Sciences
• Investigators: Principal Investigator: Michael W Best, PhD, C.Psych, University of Toronto Scarborough

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 43817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No