Clinical trial NCT05731414: Outcomes From Remediation and Behavioural Intervention Techniques
Official title: Cognitive Behavioural Therapy Compared to Cognitive Remediation for Schizophrenia-Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Psychosis
Psychotic Disorders
Schizophrenia; Psychosis
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Shores Centre for Mental Health Sciences
name: Queen's University
name: Centre for Addiction and Mental Health
name: University of British Columbia
First posted: 2023-02-16
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive a) individual CBT + group sham CR, b) group CR + individual Befriending, or c) individual CBT + group CR. Block, cohort randomization will be coordinated by the trial manager at the central site (UTSC), with stratification by treatment site. Cohorts of 5 participants will be randomized to one of the 3 treatment conditions in randomized block sizes of 4, 8, or 12 using a pre-specified randomization list.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Social Functioning Scale (SFS)
timeFrame: Change between baseline assessment and 18-month assessment
Secondary outcomes:
measure: World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Questionnaire About the Process of Recovery (QPR)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Psychotic Symptom Rating Scale (PSYRATS)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Neurocognitive Assessment
timeFrame: Change between baseline assessment and 18-month assessment
measure: Beliefs About Paranoia Scale (BAPS)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Interpretations of Voices Inventory (IVI)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Brief Core Schema Scale (BCSS)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Defeatist Beliefs Scale (from Dysfunctional Attitudes Scale, DAS)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Treatment Inventory of Costs in Patients in Psychiatric Disorders (TiC-P)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)
timeFrame: Change between baseline assessment and 18-month assessment
measure: Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)
timeFrame: Change between baseline assessment and 18 month assessment
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: University of Toronto Scarborough
state: Ontario
city: Whitby
country: Canada
facility: Ontario Shores Centre for Mental Health Sciences (Ontario Shores)
state: Ontario
Study officials:
affiliation: University of Toronto Scarborough
name: Michael W Best, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References: