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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

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 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

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

Find a Location

Who is running the clinical trial?

Queen's UniversityOTHER
371 Previous Clinical Trials
123,578 Total Patients Enrolled
4 Trials studying Schizophrenia
265 Patients Enrolled for Schizophrenia
University of British ColumbiaOTHER
1,451 Previous Clinical Trials
2,482,830 Total Patients Enrolled
14 Trials studying Schizophrenia
1,089 Patients Enrolled for Schizophrenia
University of TorontoLead Sponsor
705 Previous Clinical Trials
1,021,191 Total Patients Enrolled
4 Trials studying Schizophrenia
302 Patients Enrolled for Schizophrenia
~219 spots leftby Jan 2027
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