Action-based Cognitive Remediation for First Episode Psychosis

NCT03814122 | Completed

• 1 other identifier: H2017:214
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Psychosis

Outcome Measures

Primary Outcomes (1)

• Change in Executive Functioning; Wisconsin Card Sorting Test (Heaton and PAR Staff, 2005).

  Commonly used neuropsychological computerized test to assess the ability to form abstract concepts, to shift and maintain set, and to utilize feedback. Total number of categories completed and perseverative errors (reported as t-score with range \<20 to \>80) will be reported. Higher values indicate better outcome. More information can be found at: http://www4.parinc.com/Products/Product.aspx?ProductID=WCST

  Baseline, after approximately 8 weeks and 16 weeks

Secondary Outcomes (8)

• Change in Cognitive Functioning; Screen for Cognitive Impairment in Psychiatry (Purdon, 2005).

  Baseline, after approximately 8 weeks and 16 weeks

• Change in Psychotic Symptoms; Brief Psychotic Rating Scale (Overall & Gorham, 1962).

  Baseline, after approximately 8 weeks and 16 weeks

• Change in Functional Skills; Canadian Objective Life Skills (COALS) (McDermid Vaz & Heinrichs)

  Baseline, after approximately 8 weeks and 16 weeks

• Change in Visual Memory; Brief visuospatial memory test-revised (Benedict, 1997).

  Baseline, after approximately 8 weeks and 16 weeks

• Change in Self-Esteem; Rosenberg Self-Esteem Scale (Rosenberg, 1965).

  Baseline, after approximately 8 weeks and 16 weeks

Study Arms (2)

ABCR Treatment Group

EXPERIMENTAL

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

Behavioral: Action-based cognitive remediation

Waitlist Control Group

ACTIVE COMPARATOR

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

Behavioral: Action-based cognitive remediation; Other: Waitlist Control Group

Interventions

Action-based cognitive remediation 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.

ABCR Treatment Group; Waitlist Control Group

Waitlist Control Group OTHER

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

Waitlist Control Group

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Organic brain damage
• Intellectual disability

Sponsors & Collaborators

• University of Manitoba: lead
• Queen's University: collaborator

Study Sites (1)

Crisis Response Centre

Winnipeg, Manitoba, R3E 0Y1, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Psychotic Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Colleen Murphy, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Pre- and post- assessments will be administered by someone blind to group assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: January 23, 2019
• Study Start: February 13, 2019
• Primary Completion: June 14, 2019
• Study Completion: November 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)