Outcomes From Remediation and Behavioural Intervention Techniques
ORBIT
Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
1 other identifier
interventional
360
1 country
2
Brief 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 who might respond sufficiently to either monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Mar 2023
Typical duration for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 16, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
August 19, 2025
August 1, 2024
3.9 years
January 19, 2023
August 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Change between baseline assessment and 18-month assessment
Questionnaire About the Process of Recovery (QPR)
Change between baseline assessment and 18-month assessment
Positive and Negative Syndrome Scale (PANSS)
Change between baseline assessment and 18-month assessment
Psychotic Symptom Rating Scale (PSYRATS)
Change between baseline assessment and 18-month assessment
Neurocognitive Assessment
Change between baseline assessment and 18-month assessment
- +7 more secondary outcomes
Study Arms (3)
Individual CBTp + Group Sham CR
EXPERIMENTALIndividual 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)
EXPERIMENTALAction-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
EXPERIMENTALIndividual 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.
Interventions
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.
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.
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 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.
Eligibility Criteria
You may qualify if:
- Aged 18-65 years
- Diagnosed with schizophrenia-spectrum disorders
- Can read, write, and speak English
You may not qualify if:
- Neurodevelopmental disability or neurocognitive disorder
- CBT or CR in the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Ontario Shores Centre for Mental Health Sciencescollaborator
- Queen's Universitycollaborator
- Centre for Addiction and Mental Healthcollaborator
- University of British Columbiacollaborator
Study Sites (2)
University of Toronto Scarborough
Scarborough Village, Ontario, M1C 1A4, Canada
Ontario Shores Centre for Mental Health Sciences (Ontario Shores)
Whitby, Ontario, L1N 5S9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael W Best, PhD, C.Psych
University of Toronto Scarborough
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This will be a double-blind (participant, assessor) trial. Participants will be informed that they will receive one individual session and one group session of treatment per week but will not be told which group they are assigned to. Participants will be instructed not to talk about their therapy to the assessor but if the assessor becomes aware of group allocation, then a new assessor will be assigned for all follow-up assessments. Due to the nature of the interventions, it is not possible for therapists to be blind to treatment condition, however, therapist fidelity to each intervention will be monitored through ratings on established fidelity measures. To protect against contamination separate therapists will deliver the active and control therapies. The Principal Investigator also remains blind to randomization, as the trial manager is the only one who has access to this.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Principal Investigator
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 16, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
August 19, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share