Clinical trial NCT03814122: Action-based Cognitive Remediation for First Episode Psychosis
Official title: Examining the Effectiveness of Action-based Cognitive Remediation for First Episode Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Psychosis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2019-01-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The proposed study will be a two-group randomized control cross-over trial. Participants 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. Evaluations of the participant's cognitive functioning, self-esteem, psychotic symptoms, and functional skills will be completed at baseline, post-treatment (approximately 8 weeks), and 16 weeks later.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005).
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
Secondary outcomes:
measure: Change in Cognitive Functioning; Screen for Cognitive Impairment in Psychiatry (Purdon, 2005).
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Psychotic Symptoms; Brief Psychotic Rating Scale (Overall & Gorham, 1962).
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Functional Skills; Canadian Objective Life Skills (COALS) (McDermid Vaz & Heinrichs)
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Visual Memory; Brief visuospatial memory test-revised (Benedict, 1997).
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Self-Esteem; Rosenberg Self-Esteem Scale (Rosenberg, 1965).
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Disability Beliefs; World Health Organization Disability Assessment Schedule II (World Health Organization)
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Illness Beliefs; Personal Beliefs About Illness Questionnaire-Revised (Birchwood, Jackson, Brunet, Holden & Barton, 2012).
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
measure: Change in Perceived Competence; Perceived Competence for Learning Scale
timeFrame: Baseline, after approximately 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Crisis Response Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Colleen Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References: