Outcomes From Remediation and Behavioural Intervention Techniques
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years
Diagnosed with schizophrenia-spectrum disorders
Can read, write, and speak English
Disqualifiers
Neurodevelopmental disability or neurocognitive disorder
CBT or CR in the past 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioural Therapy for Psychosis (CBTp)
BehavioralIndividual 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)
BehavioralAction-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
BehavioralBefriending 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
BehavioralSham 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.
Treatment groups
360 Participants
are divided into 3 treatment groupsGroup A: Individual CBTp + Group Sham CRExperimental treatment 2 interventions
Group B: Group CR + Individual Befriending (Sham CBTp)Experimental treatment 2 interventions
Group C: Individual CBTp + Group CRExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Social Functioning Scale (SFS)
The Social Functioning Scale (SFS) is an interview-based measure assessing basic social adjustment skills. It can be administered to both the participant and informants. Seven aspects are evaluated: (1) social engagement/withdrawal (with raw scores ranging from 0-15); (2) interpersonal behavior (with raw scores ranging from 0-9); (3) pro-social activities (with scores ranging from 0-66); (4) recreation (with scores ranging from 0-45); (5) independence-competence (with scores ranging from 0-39); (6) independence-performance (scores ranging from 0-39); and (7) employment/occupation (with scores ranging from 0-10). The lowest total score would be a 0 while the highest would be a 223. Higher scores are indicative of better social functioning.
Time frame
Change between baseline assessment and 18-month assessmentSecondary outcomes
1
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
The WHOQOL-BREF is a 26-item self-report measure assessing quality of life. The four domains included are: (1) physical health, (2) psychological, (3) social relationships and (4) environment. Responses are rated on a 5-point scale, and reverse-scored items are included. The highest total raw score would be a 130, while the lowest would be a 26. Higher scores indicate better quality of life.
Time frame
Change between baseline assessment and 18-month assessment2
Questionnaire About the Process of Recovery (QPR)
QPR is a self-report measure assessing recovery with people experiencing psychosis. This version contains 22 items while the response to each statement is scored on a 5-point Likert scale ranging from "0 = strongly disagree" to "4 = strongly agree". The lowest possible score is 0 and the highest score could be 88. Higher scores would indicate better recovery.
Time frame
Change between baseline assessment and 18-month assessment3
Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item semi-structured interview assessing positive, negative symptoms and general psychopathology. Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, 7 = extreme). The lowest score would be a 30 and the highest score would be 210. A higher score would indicate increased symptomology. A 15-point change on the PANSS is associated with clinically meaningful change.
Time frame
Change between baseline assessment and 18-month assessment4
Psychotic Symptom Rating Scale (PSYRATS)
The PSYRATS assesses frequency and distress associated with the experiences of auditory hallucinations and delusions based on the PANSS interview. Each of the 17 items is scored on a 5-point scale, where a score of 0 indicates no presence, and 4 indicates the highest severity. The lowest score would be a 0 and the highest score would be 68. A higher score would indicate increased symptomology.
Time frame
Change between baseline assessment and 18-month assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Toronto
Lead sponsor
Ontario Shores Centre for Mental Health Sciences
Collaborator
Queen's University
Collaborator
Centre for Addiction and Mental Health
Collaborator
University of British Columbia
Collaborator
Source ClinicalTrials.gov