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Thinking Skills for Work in Severe Mental Illness (TSW)

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thinking Skills for Work Program
Supported Employment
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Chronic Mental Disorder, Employment, Cognitive remediation, Vocational rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic mental disorder
  • Minimum age 18
  • Unemployed
  • Wants employment
  • Must be a recipient of services at one of two participating agencies
  • Fluent in English
  • Willing and legally able to provide informed consent to participate in study -Subjects with court appointed legal guardians will be included

Exclusion Criteria:

  • History of neurological conditions that impair cognition

Sites / Locations

  • Thresholds, Inc.
  • Mental Health Center of Greater Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Supported Employment Only

Thinking Skills for Work

Arm Description

Supported employment is an evidence based practice designed to help people with serious mental illness obtain competitive work. This vocational model adheres to the principles of zero inclusion, rapid job search, no prevocational training, attention to client preferences and integration with clinical services.

The Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation.

Outcomes

Primary Outcome Measures

AMOUNT OF EMPLOYMENT
TOTAL HOURS OF COMPETITIVE EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.

Secondary Outcome Measures

EXECUTIVE FUNCTIONING AND MEMORY
CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 6 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 12 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 24 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.

Full Information

First Posted
August 19, 2013
Last Updated
August 20, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01926613
Brief Title
Thinking Skills for Work in Severe Mental Illness
Acronym
TSW
Official Title
Cognitive Rehabilitation and Supported Employment for Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is help people with serious mental illness and receiving vocational rehabilitation get and keep the job they want by improving their thinking skills, such as attention and memory, using computer exercises and other strategies. One half of the participants in the study will receive vocational rehabilitation and the exercises to improve thinking skills, and the other half will receive just vocational rehabilitation. All participants will receive an assessment of symptoms and thinking skills at the beginning of the study and 6, 12, and 24 months later. Work activity during the 24 months in the study will be collected. It is expected that those participants who receive the practice of their thinking skills will be more likely to get and keep the job they want compared with people who do not receive this treatment.
Detailed Description
This randomized controlled trial is evaluating the effectiveness of a pilot-tested, manualized cognitive remediation intervention entitled the "Thinking Skills for Work Program" by comparing it to enhanced supported employment services in clients with severe mental illness (SMI) who are participants in high fidelity supported employment programs at the Greater Mental health Center of Manchester and Thresholds, Inc., Chicago, Il, but who have had difficulty getting or keeping jobs. Participants are randomized to either the Thinking Skills for Work (cognitive remediation +supported employment; CT+SE) or enhanced supported employment (E-SE), with cognitive, symptom, and quality of life assessments performed at baseline, 3 months (following the completion of the computerized cognitive training component of the Thinking Skills for Work program), 12 months, and 24 months, and employment data gathered over the full 2-year period. For the E-SE condition, supported employment services are enhanced by training provided to the employment specialists regarding to recognize cognitive problems related to work performance, and how employment specialists can teach clients coping strategies for managing these problems. Primary analyses will focus on testing the hypotheses that the Thinking Skills for Work Program (CT+SE) leads to better cognitive functioning and better competitive work outcomes over the 2-year follow-up period compared to the E-SE program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Major Depression, Bipolar Disorder, Anxiety Disorder
Keywords
Schizophrenia, Chronic Mental Disorder, Employment, Cognitive remediation, Vocational rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supported Employment Only
Arm Type
Active Comparator
Arm Description
Supported employment is an evidence based practice designed to help people with serious mental illness obtain competitive work. This vocational model adheres to the principles of zero inclusion, rapid job search, no prevocational training, attention to client preferences and integration with clinical services.
Arm Title
Thinking Skills for Work
Arm Type
Experimental
Arm Description
The Thinking Skills for Work Program includes 5 components delivered by a Cognitive Specialist who works collaboratively with the consumer's Employment Specialist: a) assessing the consumer's strengths and weaknesses in cognitive functioning, and analysis of the contribution of cognitive impairments and other factors to job losses and difficulties obtaining a job; b) teaching coping strategies for dealing with cognitive challenges associated with job search or maintaining a job; c) computer cognitive training involving cognitive exercises with a commercially available software program, which is designed to improve the broad range of cognitive skills through a combination of practice and strategy coaching by the Cognitive Specialist; d) job search planning; and e) job support consultation.
Intervention Type
Behavioral
Intervention Name(s)
Thinking Skills for Work Program
Intervention Description
The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and supported employment services.
Intervention Type
Behavioral
Intervention Name(s)
Supported Employment
Intervention Description
Supported Employment is an evidence based vocational rehabilitation program
Primary Outcome Measure Information:
Title
AMOUNT OF EMPLOYMENT
Description
TOTAL HOURS OF COMPETITIVE EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL WEEKS OF EMPLOYMENT FROM BASELINE TO 24 MONTHS. TOTAL NUMBER OF JOBS HELD FROM BASELINE TO 24 MONTHS.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
EXECUTIVE FUNCTIONING AND MEMORY
Description
CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 6 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 12 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.. CHANGE FROM BASELINE IN EXECUTIVE FUNCTIONING AND MEMORY AT 24 MONTHS USING THE MATRICS COGNITIVE ASSESSMENT BATTERY.
Time Frame
BASELINE, 6, 12, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic mental disorder Minimum age 18 Unemployed Wants employment Must be a recipient of services at one of two participating agencies Fluent in English Willing and legally able to provide informed consent to participate in study -Subjects with court appointed legal guardians will be included Exclusion Criteria: History of neurological conditions that impair cognition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan R McGurk, Ph.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thresholds, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25998278
Citation
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.
Results Reference
derived

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Thinking Skills for Work in Severe Mental Illness

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