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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483701
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Ministry of Social Development and Poverty Reduction, British Columbia
Information provided by (Responsible Party):
Fraser Health

Brief 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.


Condition or disease Intervention/treatment Phase
Schizophrenia and Related Disorders Psychotic Disorder Behavioral: Cognitive Remediation Therapy Not Applicable

Detailed Description:

Background Information:

The Individual Placement and Support (IPS) program is an evidence-based vocational rehabilitation services that assist individuals with mental illness or significant mental health concerns gain and maintain competitive employment in the community. Unemployment rates among people with mental illness are high, even though most people with serious mental illness want to work.

Fraser Health provides IPS services to approximately 350 MHSU clients per year in six communities. The IPS strategy helps about 55% of clients find competitive jobs, but almost half (45%) fail to find work. Among those who fail to find employment, cognitive dysfunction is often a significant problem.

Cognitive remediation therapy (CRT) is an evidence-based, psychological treatment for the neurocognitive deficits seen in patients with severe mental illness. CRT targets cognitive functioning with the goal of improving role functioning in daily life. When compared with employment intervention alone, programs that incorporate CRT have shown a variety of vocational benefits, (e.g., more likely to work, held more jobs, worked more weeks, and earned more in wages) that are maintained even at a 3-year follow-up. CRT targeted to clients who have not been successful with IPS is efficient: non-responders improved employment outcome with a number needed-to-treat (NNT) of 4 over a two-year period.

Cognitive remediation (CRT) improves thinking skills and work functioning. CRT provides specific training modules and exercises that target thinking skills known to be impaired in severe mental illness. For example, working memory and cognitive flexibility are trained through real-world exercises that teach clients to organize and manage time, focus their attention, consider errors and their consequences, control answers and plan ahead. These skills are important to be successful in obtaining and maintaining employment.

Purpose of Study:

The primary purpose of this study is to assess, for people with serious mental illness who have failed to find employment despite three months of support in the IPS program, the effects of 12 weeks of cognitive remediation therapy (CRT) on subsequent employment outcomes while they continue to receive IPS employment-support services. Hypothesis:

The first hypothesis is that adding CRT for those who have not found employment by 3 months in the program will result in better competitive work outcomes, compared to those who continue IPS alone. The second hypothesis is that participants receiving CRT will improve more in cognitive functioning than those who did not receive CRT training. The third hypothesis is that symptom severity will be related to work outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: This randomized controlled trial will use a single-blind study design with two treatment arms. The research team that assesses participants at baseline and follow-up will have no knowledge of their assigned treatment arm. The participants, however, will know which treatment arm they have been assigned.
Primary Purpose: Treatment
Official Title: Cognitive Remediation Therapy for Patients With Serious Mental Illness Who Failed to Benefit From Supported Employment
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: Cognitive Remediation Therapy
Participants in the experimental group will continue to receive IPS services, which is part of their standard care. In addition, they will be required to complete up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer, on their own schedule. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, learn about different cognitive domains and develop ways to generalize their cognitive remediation gains.
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.

No Intervention: Treatment as Usual
Participants in the control condition will continue to receive IPS services as usual.



Primary Outcome Measures :
  1. Employment Outcomes [ Time Frame: 90 days ]
    The number of hours client worked in the past 90 days.


Secondary Outcome Measures :
  1. Cognitive Functioning [ Time Frame: 90 minutes ]
    Cognitive functioning will be measured using the Matrics Consensus Cognitive Battery. The MCCB has 10 tests that measures 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Raw scores will be converted to T-score for each domain. T-score has a mean of 50 and a standard deviation of 10.

  2. Psychiatric Symptoms [ Time Frame: 2 weeks ]
    Brief Psychiatric Rating Scale. The BPRS is a semi-structured interview of psychiatric symptoms over the past 2 weeks. There are 24 items rated from 1 to 7 with higher scores indicating more severe symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants aged 19-60 years old
  • Enrolled in the IPS program for at least 3 months
  • Clinically stable (no changes to psychiatric medication and psychiatric hospitalization in the 30 days prior to intake)

Exclusion Criteria:

  • History of traumatic brain injury
  • Neurological disorder
  • Developmental disability
  • Difficulty understanding written and spoken English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483701


Contacts
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Contact: Amy Burns, PhD 604-375-1476 amy.burns@fraserhealth.ca
Contact: David Erickson, PhD 604-520-4663 david.erickson@fraserhealth.ca

Locations
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Canada, British Columbia
Fraser Health: Royal Columbian Hospital Recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Contact: Amy Burns, PhD    604-375-1476    amy.burns@fraserhealth.ca   
Contact: David Erickson, PhD    604-520-4663    david.erickson@fraserhealth.ca   
Sponsors and Collaborators
Fraser Health
Ministry of Social Development and Poverty Reduction, British Columbia
Investigators
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Principal Investigator: David Erickson, PhD Fraser Health

Publications:

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Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT03483701    
Other Study ID Numbers: FHREB No. 2016-096
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fraser Health:
Cognitive Remediation Therapy
Additional relevant MeSH terms:
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Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders