Outcomes From Remediation and Behavioural Intervention Techniques (ORBIT)

University of Toronto

Status: Enrolling

Conditions: Psychotic Disorders; Psychosis; Schizophrenia; Schizophrenia; Psychosis

Treatments: Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp); Behavioral: Befriending; Behavioral: Cognitive Remediation Therapy (CR); Behavioral: Sham Cognitive Remediation

Study type: Interventional

Funder types: Other

Identifiers

NCT05731414

43817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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360 participants in 3 patient groups

Individual CBTp + Group Sham CR

Experimental group

Description:

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.

Treatment:

Behavioral: Sham Cognitive Remediation

Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp)

Group CR + Individual Befriending (Sham CBTp)

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Remediation Therapy (CR)

Behavioral: Befriending

Individual CBTp + Group CR

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive Remediation Therapy (CR)

Behavioral: Cognitive Behavioural Therapy for Psychosis (CBTp)