Recruiting

Observational Study

Sponsor:

University of Toronto

Code:

NCT05731414

Conditions

Schizophrenia

Psychosis

Psychotic Disorders

Schizophrenia; Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioural Therapy for Psychosis (CBTp)

Cognitive Remediation Therapy (CR)

Befriending

Sham Cognitive Remediation

Study Details

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.

Conditions

Schizophrenia

Psychosis

Psychotic Disorders

Schizophrenia; Psychosis

Study ID

NCT05731414

Start date

Mar 1, 2023

Status verified date

Aug, 2024

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Individual CBTp + Group Sham CR

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.

experimental: Group CR + Individual Befriending (Sham CBTp)

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.

experimental: Individual CBTp + Group CR

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.

Interventions

Cognitive Behavioural Therapy for Psychosis (CBTp)

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. This approach has demonstrated moderate to large improvements on symptoms and small to moderate effects on functioning. The first four sessions are devoted to building therapeutic rapport and developing collaborative treatment goals. The following phase focuses on developing formulations of why difficulties persist and using cognitive and behavioural change strategies. A longitudinal formulation is then offered to better understand how their difficulties developed. The final 2-4 sessions focus on consolidating the learning that occurred during treatment so that participants can maintain their improvement. Therapy homework is collaboratively assigned at the end of sessions to promote new learning in between sessions.

Cognitive Remediation Therapy (CR)

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. ABCR involves practicing computerized training exercises with difficulty level dynamically titrated to improve neurocognitive abilities. Then participants engage in strategy discussions with other group members to develop new cognitive strategies. Finally, participants complete role-play simulations of real-world activities to practice their cognitive strategies in simulations of everyday life. ABCR is more effective for improving functioning than traditional approaches to CR. Homework consists of additional cognitive training and practicing cognitive strategies in everyday life.

Befriending

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. Befriending consists of 1-hour individual sessions once per week and involves a series of conversations similar to those one might have with a social acquaintance. These conversations involve discussion of neutral topics without problem-solving, coping strategies, or exploration of emotion. If emotional or mental health-related topics are brought up therapists redirect back to a neutral topic.

Sham Cognitive Remediation

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. Participants practice similar computerized exercises to ABCR, however, the exercises do not increase in difficulty. Participants then discuss enjoyment of the exercises but any discussion of cognitive strategies is redirected back to a neutral topic. We have previously found this condition to be an effective control for CR, with similar engagement to the active training group.

Primary outcome measure

  • Social Functioning Scale (SFS) [ Time Frame: Change between baseline assessment and 18-month assessment ]

Central Contacts and Locations

Central contacts

Locations

University of Toronto Scarborough

Recruiting

Scarborough Village, Ontario, Canada, M1C 1A4

Contacts

Principal Investigator:

Michael W Best, PhD

Ontario Shores Centre for Mental Health Sciences (Ontario Shores)

Recruiting

Whitby, Ontario, Canada, L1N 5S9

More Information

Sponsor

University of Toronto

Last update posted

Aug 19, 2025

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2025-08-19.