Thinking Skills at Work: Cognitive Remediation Therapy for Patients With Serious Mental Illness

NCT03483701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-07-23

No results posted yet for this study

Summary

The purpose of this study is to help people with serious mental illness get and keep the job they want by improving their thinking skills, using cognitive remediation therapy. For people with serious mental illness, the Individual Placement and Support (IPS) Program is an effective approach to help people become employed. Despite its general success, still only 55% of clients find employment. Most of that success occurs in the first three months; after six months, the chances of finding competitive work are quite low. Among those who fail to find employment with IPS, cognitive dysfunction is often a significant problem. The proposed study will target IPS clients who have not found work after 3 months of employment-support services: our hypothesis is that, after three months with no success, the addition of cognitive remediation to IPS will improve employment rates (compared to those who continue to receive IPS alone).

The proposed randomized controlled trial will use a single-blind study design, focused on IPS clients who are slow to (or may never) find employment success. Specifically, the proposed study will have two treatment arms: a) cognitive remediation added to continued IPS services, and b) continued IPS services alone. The study will collaborate with IPS workers at 11 Mental Health and Substance Use (MHSU) clinics to identify clients who are non-responders in the first 3 months, and seek their consent to participate in the study. They will be randomized to either TAU (continuation with IPS and other standard treatments), or TAU plus cognitive remediation. The CRT will consist of computerized cognitive exercise practice, strategy coaching, and teaching coping/compensatory strategies for 12 weeks. Clients will be assessed at 3-time points: prior to the start of cognitive remediation ("baseline"), end-point (3-month), and 6 months after the endpoint evaluation. Primary outcome measures will include success at gaining a competitive job, total hours of competitive employment, and neuropsychological measures of cognition.

Conditions

  • Schizophrenia and Related Disorders
  • Psychotic Disorder

Interventions

BEHAVIORAL

Cognitive Remediation Therapy

The intervention of interest for participants in the experimental group is the addition of up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer. For participants without access to a computer, a laptop/tablet computer with the necessary software will be provided for the duration of training. Participants will be able to complete the cognitive exercises on their own schedule, with participation verified by the software. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, e.g. to learn about different cognitive domains and develop ways to generalize their cognitive remediation gains.

Sponsors & Collaborators

  • Ministry of Social Development and Poverty Reduction, British Columbia

    collaborator OTHER
  • Fraser Health

    lead OTHER

Principal Investigators

  • David Erickson, PhD · Fraser Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-03-31
Completion
2020-05-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483701 on ClinicalTrials.gov