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CBT + CR for Schizophrenia (ORBIT Trial)

N/A

Recruiting

Led By Michael W Best, PhD, C.Psych

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-65 years

Diagnosed with schizophrenia-spectrum disorders

Must not have

Cognitive Behavioral Therapy (CBT) or Cognitive Remediation (CR) in the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline assessment and 18-month assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find out which factors can predict whether individuals with schizophrenia will respond better to Cognitive Behavioural Therapy or Cognitive Remediation Therapy. The goal is to determine who needs both therapies and who can

Who is the study for?

This trial is for English-speaking adults aged 18-65 who have been diagnosed with schizophrenia-spectrum disorders. It's not suitable for individuals outside this age range or those who cannot read, write, and speak English.

What is being tested?

The study is testing the effectiveness of Cognitive Behavioural Therapy for Psychosis (CBTp) and Cognitive Remediation Therapy (CR), alone or combined. It aims to identify which patients benefit most from each therapy or the combination.

What are the potential side effects?

Since CBTp and CR are non-medical treatments involving therapy sessions, they may cause temporary discomfort like stress or emotional fatigue due to discussing personal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with a schizophrenia-spectrum disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone CBT or CR therapy within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline assessment and 18-month assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline assessment and 18-month assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline assessment and 18-month assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Social Functioning Scale (SFS)

Secondary study objectives

Beliefs About Paranoia Scale (BAPS)

Brief Core Schema Scale (BCSS)

Davos Assessment of Cognitive Biases in Schizophrenia (DACOBS)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Individual CBTp + Group Sham CRExperimental Treatment2 Interventions

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.

Group II: Individual CBTp + Group CRExperimental Treatment2 Interventions

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.

Group III: Group CR + Individual Befriending (Sham CBTp)Experimental Treatment2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Befriending

2014

N/A

~150

Sham Cognitive Remediation

2013

N/A

~100