NCT01926613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

3.5 years

First QC Date

August 19, 2013

Last Update Submit

August 20, 2013

Conditions

Keywords

SchizophreniaChronic Mental DisorderEmploymentCognitive remediationVocational rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • EXECUTIVE FUNCTIONING AND MEMORY

    BASELINE, 6, 12, and 24 months

Study Arms (2)

Supported Employment Only

ACTIVE COMPARATOR

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.

Behavioral: Supported Employment

Thinking Skills for Work

EXPERIMENTAL

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.

Behavioral: Thinking Skills for Work Program

Interventions

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.

Thinking Skills for Work

Supported Employment is an evidence based vocational rehabilitation program

Supported Employment Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of neurological conditions that impair cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thresholds, Inc.

Chicago, Illinois, 60613, United States

Location

Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDepressive Disorder, MajorBipolar DisorderAnxiety Disorders

Interventions

Employment, Supported

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDepressive DisorderMood DisordersBipolar and Related Disorders

Intervention Hierarchy (Ancestors)

EmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susan R McGurk, Ph.D.

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

April 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2011

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations