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

NCT03483701 | Completed

• 1 other identifier: FHREB No. 2016-096
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia and Related Disorders; Psychotic Disorder

Keywords

Cognitive Remediation Therapy

Outcome Measures

Primary Outcomes (1)

• Employment Outcomes

  The number of hours client worked in the past 90 days.

  90 days

Secondary Outcomes (2)

• Cognitive Functioning

  90 minutes

• Psychiatric Symptoms

  2 weeks

Study Arms (2)

Cognitive Remediation Therapy

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Participants in the control condition will continue to receive IPS services as usual.

Interventions

Cognitive Remediation Therapy BEHAVIORAL

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.

Cognitive Remediation Therapy

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Fraser Health: lead
• Ministry of Social Development and Poverty Reduction, British Columbia: collaborator

Study Sites (1)

Fraser Health: Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Related Publications (7)

• Marshall T, Goldberg RW, Braude L, Dougherty RH, Daniels AS, Ghose SS, George P, Delphin-Rittmon ME. Supported employment: assessing the evidence. Psychiatr Serv. 2014 Jan 1;65(1):16-23. doi: 10.1176/appi.ps.201300262.

  PMID: 24247197 BACKGROUND

• Green MF, Kern RS, Heaton RK. Longitudinal studies of cognition and functional outcome in schizophrenia: implications for MATRICS. Schizophr Res. 2004 Dec 15;72(1):41-51. doi: 10.1016/j.schres.2004.09.009.

  PMID: 15531406 BACKGROUND

• McGurk SR, Mueser KT. Cognitive functioning, symptoms, and work in supported employment: a review and heuristic model. Schizophr Res. 2004 Oct 1;70(2-3):147-73. doi: 10.1016/j.schres.2004.01.009.

  PMID: 15329293 BACKGROUND

• McGurk SR, Mueser KT, Feldman K, Wolfe R, Pascaris A. Cognitive training for supported employment: 2-3 year outcomes of a randomized controlled trial. Am J Psychiatry. 2007 Mar;164(3):437-41. doi: 10.1176/ajp.2007.164.3.437.

  PMID: 17329468 BACKGROUND

• McGurk SR, Mueser KT, Xie H, Welsh J, Kaiser S, Drake RE, Becker DR, Bailey E, Fraser G, Wolfe R, McHugo GJ. Cognitive Enhancement Treatment for People With Mental Illness Who Do Not Respond to Supported Employment: A Randomized Controlled Trial. Am J Psychiatry. 2015 Sep 1;172(9):852-61. doi: 10.1176/appi.ajp.2015.14030374. Epub 2015 May 22.

  PMID: 25998278 BACKGROUND

• Bell MD, Zito W, Greig T, Wexler BE. Neurocognitive enhancement therapy with vocational services: work outcomes at two-year follow-up. Schizophr Res. 2008 Oct;105(1-3):18-29. doi: 10.1016/j.schres.2008.06.026. Epub 2008 Aug 19.

  PMID: 18715755 BACKGROUND

• Kurtz MM, Wexler BE, Fujimoto M, Shagan DS, Seltzer JC. Symptoms versus neurocognition as predictors of change in life skills in schizophrenia after outpatient rehabilitation. Schizophr Res. 2008 Jul;102(1-3):303-11. doi: 10.1016/j.schres.2008.03.023. Epub 2008 May 20.

  PMID: 18495433 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• David Erickson, PhD

  Fraser Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 30, 2018
• Study Start: April 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: May 25, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

CA (1)