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: Not yet 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 (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felicia Martins, HBSc; Phone Number: 100 6476896098; Email: felicia.martins@mail.utoronto.ca
• Study Contact Backup: Name: Michael W Best, PhD, C.Psych; Phone Number: 6476014551; Email: m.best@utoronto.ca

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Primary substance use disorder
• Neurodevelopmental disability or neurocognitive disorder
• Neurostimulation in the past 30 days
• 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	The Social Functioning Scale (SFS) is an interview-based measure administered to an informant and assesses domains of social engagement, interpersonal communication, independence, recreation, prosocial behavior, and vocational activities. Items have various scales and ways to interpret them since this is a longer, interview-based measure.	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)	Quality of Life will be assessed using the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF), which contains 26 items assessing 4 domains: physical health, psychological, social relationships, and environment. The WHOQOL-BREF is reliable and valid in schizophrenia.	Change between baseline assessment and 18-month assessment
Questionnaire About the Process of Recovery	Personal Recovery will be assessed using the Questionnaire About the Process of Recovery, a 15-item self-report measure collaboratively developed with service-users experiencing psychosis.	Change between baseline assessment and 18-month assessment
Positive and Negative Syndrome Scale (PANSS)	Psychiatric Symptoms will be assessed with the Positive and Negative Syndrome Scale (PANSS), the gold standard symptom interview for schizophrenia. The PANSS assesses positive, negative, and general symptoms, and 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 Psychotic Symptom Rating Scale (PSYRATS) is an interview assessing dimensions of hallucination and delusion severity that members of our team validated.	Change between baseline assessment and 18-month assessment
MATRICS Consensus Cognitive Battery (MCCB)	Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery (MCCB), the gold standard assessment of cognitive functions for schizophrenia. The MCCB assesses domains of processing speed, sustained attention, verbal learning, visual learning, working memory, and reasoning / problem solving. Extensive normative data will be used to generate a global neurocognitive composite score.	Change between baseline assessment and 18-month assessment
Beliefs About Paranoia Scale (BAPS)	Assesses cognitive content. Each item was scored on a 4-point scale to measure conviction (1 = not at all, 2 = somewhat, 3 = moderately so, 4 = very much).	Change between baseline assessment and 18-month assessment
Interpretations of Voices Inventory (IVI)	Assesses cognitive content.	Change between baseline assessment and 18-month assessment
Brief Core Schema Scale (BCSS)	Assesses cognitive content. Participants indicate whether they hold each of the beliefs using No or Yes, and if they do hold the belief, they indicate how strongly they hold it by circling the numbers 1 to 4 (believe it slightly, believe it moderately, believe it very much, believe it totally).	Change between baseline assessment and 18-month assessment
Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)	Assesses cognitive content. 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
Questionnaire on Healthcare Consumption and Productivity Losses for Patients with a Psychiatric Disorder (TiC-P)	The TiC-P is a self-report measure that has been validated against objective health data.	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 (Anticipated): March 1, 2023
• Primary Completion (Anticipated): January 31, 2027
• Study Completion (Anticipated): 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): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

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