Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- University of Toronto
- Enrollment
- 360
- Locations
- 2
- Primary Endpoint
- Social Functioning Scale (SFS)
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
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.
Investigators
Michael Best
Assistant Professor, Principal Investigator
University of Toronto
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Neurocognitive Assessment(Change between baseline assessment and 18-month assessment)
- World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)(Change between baseline assessment and 18-month assessment)
- Interpretations of Voices Inventory (IVI)(Change between baseline assessment and 18-month assessment)
- Brief Core Schema Scale (BCSS)(Change between baseline assessment and 18-month assessment)
- Psychotic Symptom Rating Scale (PSYRATS)(Change between baseline assessment and 18-month assessment)
- Beliefs About Paranoia Scale (BAPS)(Change between baseline assessment and 18-month assessment)
- Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)(Change between baseline assessment and 18-month assessment)
- Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P)(Change between baseline assessment and 18-month assessment)
- Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)(Change between baseline assessment and 18 month assessment)
- Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)(Change between baseline assessment and 18-month assessment)