Outcomes From Remediation and Behavioural Intervention Techniques
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR), Befriending, Sham Cognitive Remediation.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Psychosis, Psychotic Disorders, Schizophrenia; Psychosis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
Overview
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:
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.
Interventions
- 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 - 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. Finall - 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 exploratio - 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
Primary outcome measures
- Social Functioning Scale (SFS) [Time frame: Change between baseline assessment and 18-month assessment]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- University of Toronto Scarborough — Scarborough Village
- Ontario Shores Centre for Mental Health Sciences (Ontario Shores) — Whitby
Identifiers
NCT: NCT05731414 · 43817