Thinking Skills for Work in Severe Mental Illness

Schizophrenia Clinical Trial

— TSW  

Official title:

Cognitive Rehabilitation and Supported Employment for Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926613
• Other study ID #: MH077210
• Secondary ID: 1R01MH077210-01
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: August 20, 2013
• Start date: April 2006
• Est. completion date: October 2011

Study information

• Verified date: August 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Bipolar Disorder
• Depressive Disorder, Major
• Disease
• Major Depression
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Thinking Skills for Work Program
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.
• Supported Employment
Supported Employment is an evidence based vocational rehabilitation program

Locations

Country	Name	City	State
United States	Thresholds, Inc.	Chicago	Illinois
United States	Mental Health Center of Greater Manchester	Manchester	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months	No
Secondary	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.	BASELINE, 6, 12, and 24 months	No