CBT + CR for Schizophrenia

(ORBIT Trial)

Recruiting at 2 trial locations

Overseen By Mike W Best, PhD, C.Psych

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Neurodevelopmental disability, Neurocognitive disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different therapies can assist individuals with schizophrenia-spectrum disorders. It seeks to determine what factors enhance response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR), or whether a combination is most effective. Participants will join one of three groups: one receiving both therapies, one receiving therapy and a placebo, or one receiving CR and supportive social interaction (Befriending). Suitable candidates have schizophrenia-spectrum disorders and have not undergone CBT or CR in the past six months. As an unphased trial, this study provides participants the chance to contribute to the understanding and improvement of therapeutic approaches for schizophrenia-spectrum disorders.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that Cognitive Behavioural Therapy for Psychosis (CBTp) effectively reduces symptoms of psychosis, particularly positive symptoms like hallucinations and delusions. This well-established treatment is widely used in many countries for individuals with or at risk of psychosis, indicating its safety.

Research has shown that Cognitive Remediation Therapy (CR) for people with schizophrenia is safe and practical. Studies have found that participants usually adhere to the treatment schedule and report few safety concerns. CR helps improve cognitive skills like memory and attention in individuals with schizophrenia.

Overall, both CBTp and CR have been studied in many clinical trials and are considered safe for individuals with schizophrenia-spectrum disorders. Participants generally tolerate these therapies well, making them reliable treatment options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Cognitive Behavioural Therapy for Psychosis (CBTp) and Cognitive Remediation Therapy (CR) for schizophrenia because it targets both the psychological and cognitive challenges faced by patients. Unlike standard treatments such as antipsychotic medications that primarily address symptoms like hallucinations and delusions, CBTp focuses on helping individuals manage their thoughts and behaviors, while CR aims to improve cognitive functions like memory and attention. The innovative approach of including group-based Action-Based Cognitive Remediation (ABCR), developed by experts Dr. Bowie and Dr. Best, and the use of a sham CR for control purposes, offer a unique method to enhance the overall effectiveness of therapy for schizophrenia-spectrum disorders. This dual approach has the potential to improve both cognitive and emotional well-being, offering a comprehensive treatment strategy that could significantly enhance quality of life for individuals with schizophrenia.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that Cognitive Behavioural Therapy for Psychosis (CBTp), which participants in this trial may receive, can significantly aid individuals with schizophrenia-related disorders. It reduces symptoms such as delusions (strong beliefs not based on reality) and auditory hallucinations (hearing things that aren't there). Studies indicate that CBTp has small to medium positive effects on these symptoms. Meanwhile, Cognitive Remediation (CR), another treatment option in this trial, improves mental skills like attention and memory in people with schizophrenia. When combined with other therapies, CR further enhances overall functioning. Multiple studies have proven both therapies effective, addressing different aspects of schizophrenia. ^{4 6 7 8 9}

Who Is on the Research Team?

Michael W Best, PhD, C.Psych

Principal Investigator

University of Toronto Scarborough

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with a schizophrenia-spectrum disorder.

Exclusion Criteria

Neurodevelopmental disability or neurocognitive disorder

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cognitive Behavioural Therapy for Psychosis (CBTp), Cognitive Remediation Therapy (CR), or a combination of both. Individual CBTp is delivered for one hour per week, and group CR is delivered in one-hour sessions per week.

18 months

Weekly sessions

Follow-up

Participants are monitored for changes in social functioning, quality of life, personal recovery, psychiatric symptoms, and neurocognition.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Befriending
• Cognitive Behavioural Therapy for Psychosis (CBTp)
• Cognitive Remediation Therapy (CR)
• Sham Cognitive Remediation

Trial Overview

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.

How Is the Trial Designed?

Group I: Individual CBTp + Group Sham CR Experimental Treatment 2 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 CR Experimental Treatment 2 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 Treatment 2 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.

Cognitive Behavioural Therapy for Psychosis (CBTp) is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as CBTp for:

• Schizophrenia
• Psychotic disorders

Approved in United States as CBTp for:

• Schizophrenia
• Psychotic disorders

Approved in United Kingdom as CBTp for:

• Schizophrenia
• Psychotic disorders

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Ontario Shores Centre for Mental Health Sciences

Collaborator

Trials

15

Recruited

2,400+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Queen's University

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Published Research Related to This Trial

Cognitive remediation (CR) prior to cognitive-behavioral therapy for psychosis (CBTp) did not significantly reduce psychotic symptoms compared to social contact, but it did lead to shorter CBTp courses, averaging 7 sessions compared to 13 sessions for the control group.

While overall cognitive improvement was not significantly greater after CR, specific enhancements in executive function were observed, suggesting that CR can effectively support CBTp and potentially reduce treatment costs with minimal training for staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A naturalistic, randomized, controlled trial combining cognitive remediation with cognitive-behavioural therapy after first-episode non-affective psychosis. Drake, RJ., Day, CJ., Picucci, R., et al.[2022]

Cognitive remediation therapy (CRT) significantly improved cognitive functioning and insight in 126 patients with chronic schizophrenia over three months, compared to standard treatment methods.

While both CRT and treatment as usual (TAU) groups showed improvements in social functioning, the CRT group had notably greater enhancements in cognitive measures and insight, highlighting its effectiveness as an adjunctive treatment to antipsychotic medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on adjunctive cognitive remediation therapy for chronically hospitalized patients with schizophrenia. Lu, H., Li, Y., Li, F., et al.[2021]

Cognitive Remediation (CR) therapy significantly improved non-verbal memory and functioning in 46 participants with psychosis, suggesting its efficacy in addressing cognitive difficulties associated with the condition.

The study highlights the importance of therapeutic alliance, as it was linked to improvements in functioning and cognitive outcomes, indicating that the relationship between the therapist and the patient plays a crucial role in the effectiveness of CR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nuts and bolts of Cognitive Remediation: Exploring how different training components relate to cognitive and functional gains. Cella, M., Wykes, T.[2022]

The new computerized cognitive remediation program, CIRCuiTS, was found to be highly acceptable and easy to use for both individuals with schizophrenia and clinicians, based on feedback from 34 non-clinical participants and 20 service users.

Participants reported positive experiences with CIRCuiTS, noting improvements in cognitive functioning and a desire to apply new strategies in their daily lives, indicating its potential effectiveness in cognitive therapy for psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Acceptability to Service Users of CIRCuiTS, a Computerized Cognitive Remediation Therapy Programme for Schizophrenia. Reeder, C., Pile, V., Crawford, P., et al.[2022]

In a study involving 62 patients with Schizophrenia Spectrum Disorders, a short computer-based Cognitive Remediation Therapy (CRT) program showed modest improvements in visual memory but did not significantly enhance attention or executive functions.

The CRT consisted of 10 sessions using the Cogpack software, suggesting that while short-term CRT can have some benefits, a longer and more comprehensive rehabilitation approach may be necessary for more substantial cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Short Course Computer-assisted Cognitive Remediation in Patients with Schizophrenia Spectrum Disorders: A Randomized Clinical Trial. Hatami, S., Mirsepassi, Z., Sedighnia, A., et al.[2022]

Cognitive remediation training (CRT) significantly improved cognitive abilities in 92 out of 109 patients with first episode psychosis (FEP) after completing a 24-session program, with notable enhancements in verbal memory, digit sequencing, and symbol coding.

The study supports the effectiveness of CRT in an Asian population, suggesting that similar cognitive training programs could be beneficial in other early psychosis intervention services across Asia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation and Review of Cognitive Remediation Training for First Episode Psychosis in Singapore. Chong, NIM., Maniam, Y., Chua, YC., et al.[2021]

Many training directors in US psychiatry and psychology programs lack knowledge about the effectiveness of Cognitive-Behavioral Therapy for psychosis (CBTp), with only 50% of psychiatry and 40% of psychology directors recognizing its efficacy.

Training opportunities for CBTp are severely limited, with programs offering only a few hours of didactic and practical training, which is insufficient for effectively implementing CBTp in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Psychosis - Training Practices and Dissemination in the United States. Kimhy, D., Tarrier, N., Essock, S., et al.[2021]

The first online cognitive remediation (CR) therapist training program was developed and evaluated, showing that it is feasible and acceptable for mental health professionals, with most participants completing the training successfully.

The training significantly improved knowledge among clinicians, particularly benefiting those with less experience, indicating its potential to enhance the delivery of CR in treating psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new online cognitive remediation therapy (CIRCuiTSTM ) training for mental health professionals. Taylor, R., Crowther, A., Tinch-Taylor, R., et al.[2023]

In a study of 198 schizophrenia patients, cognitive behavioral therapy (CBT) and cognitive remediation (CR) showed similar safety profiles, with low rates of severe adverse events (SAEs) over 12 months, including no suicides reported.

Both CBT and CR resulted in increases in negative symptoms for a significant number of patients, but these increases were not statistically different, indicating that while some patients may experience worsening symptoms, the overall safety of both therapies remains relatively high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cognitive behavioral therapy and cognitive remediation in schizophrenia: results of the treatment of negative symptoms study. Klingberg, S., Herrlich, J., Wiedemann, G., et al.[2018]

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