Action-based Cognitive Remediation for First Episode Psychosis

NCT ID: NCT03814122

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2019-11-30

Brief Summary

Cognitive impairments are a core and enduring feature of first-episode psychosis and schizophrenia, and are associated with significant functional impairment. Cognitive remediation (CR) is a behavioural intervention that has been found to have a small to moderate effect on cognition in individuals with schizophrenia, and recent studies suggests that it leads to improved cognition in persons with first-episode psychosis. Results from a CR feasibility project that was conducted through the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service (EPPIS) showed promising findings. Specifically, large effect sizes were found in the areas of verbal learning and self-esteem. Moreover, the intervention was found to be acceptable to the participants. However, the findings are limited by the sample size and lack of control group.

In this proposed study, the investigators seek to expand the scientific support for treating neurocognitive impairments in order to increase functional productivity associated with first-episode psychosis. A novel group CR program, action-based cognitive remediation (ABCR), has been developed by Dr. C. Bowie (co-investigator) to promote the generalization of cognitive skills to real-world activities. ABCR has been found to improve both cognition and functional competence in persons with schizophrenia. The primary outcome measure will examine whether ABCR results in improved executive functioning in persons with first-episode psychosis compared to psychiatric rehabilitation alone. Secondary outcome measures (e.g., memory, processing speed, self-esteem, emotional functioning, adaptive functioning) will also be analyzed.

Detailed Description

The proposed study will be a two-group randomized control cross-over trial. Participants will be recruited from EPPIS and will be randomly assigned to receive ABCR or treatment-as-usual (TAU) for a period of 8 weeks. After this time, the TAU group will receive ABCR. TAU will be the psychiatric rehabilitation programming offered to all patients enrolled with EPPIS. ABCR will consist of two, 2-hour groups/week, for a period of 8 weeks. Each group session will consist of: (1) computerized cognitive training using Scientific Brain Training Pro (an online program used in previous CR and ABCR research), (2) strategic monitoring (i.e., increasing awareness of cognitive strategies used and learning to switch strategies as needed), (3) role-plays and simulations of real world tasks to facilitate the transfer of skills to functioning, and (4) goal setting and cognitive approach planning. ABCR builds on procedural learning skills with explicit work-related role-plays to facilitate the immediate and salient abstraction of drill and practice remediation techniques. The activities are work skills that were developed by Dr. Bowie (co-investigator) in collaboration with community vocational rehabilitation partners. The props match those used in work settings and were designed on a miniature scale and include a cash register, filing system, conveyer belt, cleaning closet, garden nursery, and secretarial station. The activities in ABCR capitalize on procedural learning skills through role-plays and props that simulate a work environment. In ABCR, the important aspects of drill and practice, strategic monitoring to enhance flexible problem solving approaches, and bridging are maintained. The role-plays immediately follow the computerized drill and practice exercise and therapists facilitate group discussions of how the cognitive skills and flexibility in thinking from drill and practice can be effective while directly engaged in an everyday work environment. Thus, the bridging used in ABCR is a tangible, procedural, and realistic. This approach to bridging differentiates the treatment from standard CR, where the discussion-based approach is limited by the auditory learning, memory, and abstraction deficits typically observed in psychosis. ABCR group sessions will be facilitated by the Primary Investigator and trained bachelor's or master's level research assistants/psychology residents who will be trained and supervised by the Primary Investigator. Participants will also be encouraged to complete computerized cognitive training using the online program, Scientific Brain Training Pro as supplemental homework exercises outside of the scheduled treatment group (20 minutes/day). Due to the online nature of this program, participants can access this program either at their personal homes or at EPPIS.

Evaluations of each participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline and post-treatment (approximately 8 weeks later). The TAU group will then participate in ABCR and all participants will be re-evaluated following completion of the second intervention (at approximately 16 weeks post-baseline). Testing will be administered by trained bachelor's or master's level research assistants who are blind to study hypothesis or group assignment. These assistants will be trained and supervised by the Primary Investigator. Test batteries will be presented in counterbalanced order and, when possible, alternate forms will be used to reduce the likelihood of practice effects.Using a repeated measures analysis of covariance (ANCOVA), the treatment and control group's post-intervention data will be compared while controlling for pre-treatment scores. For all analyses, p < .05 will be used as the statistical threshold for significance.

Conditions

Cognitive Impairment; Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ABCR Treatment Group

Group that is immediately administered action-based cognitive remediation intervention.

Group Type: EXPERIMENTAL

Action-based cognitive remediation

Intervention Type: BEHAVIORAL

Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.

Waitlist Control Group

Group that is waitlisted (i.e., receives treatment-as-usual) and after approximately 8 weeks received action-based cognitive remediation intervention

Group Type: ACTIVE_COMPARATOR

Action-based cognitive remediation

Intervention Type: BEHAVIORAL

Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.

Waitlist Control Group

Intervention Type: OTHER

Receive treatment-as-usual through regular early psychosis programming.

Interventions

Action-based cognitive remediation

Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.

Intervention Type: BEHAVIORAL

Waitlist Control Group

Receive treatment-as-usual through regular early psychosis programming.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Involved in the Winnipeg Regional Health Authority's Early Psychosis Prevention and Intervention Service
• Must be at least 18 years old
• Be proficient in English
• Have stable medication orders for 3 months
• Have capacity to voluntarily consent to participate in the treatment study

Exclusion Criteria

• Organic brain damage
• Intellectual disability

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colleen Murphy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Crisis Response Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

H2017:214

Identifier Type: -

Identifier Source: org_study_id