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Comparing Thinking Skills for Work (TSW)Home Practice Program With Traditional TSW Program

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2016 by Boston University
Sponsor:
Information provided by (Responsible Party):
Susan Mcgurk, Boston University
ClinicalTrials.gov Identifier:
NCT03005574
First received: December 26, 2016
Last updated: January 1, 2017
Last verified: December 2016
  Purpose
The purpose of this study is to determine if using a tablet computer, which is a very small, easy-to-carry computer, to practice thinking exercises at home will help improve your attention, memory, and problem solving abilities. All the participants will receive training in the thinking skills for work program. But in order to determine the effect of tablet use for home practice, half of the participants will be given a tablet to practice the thinking exercises at home. All participants will be receiving vocational rehabilitation and have a goal of getting a job.

Condition Intervention
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression
Behavioral: TSW-HP
Behavioral: TSW-T

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Impact of Thinking Skills for Work (TSW)Tablet-based Home Practice Program on Cognitive Functioning and Work With the Traditional TSW Program

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Composite Measure of Change in Neurocognitive Functioning [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery


Estimated Enrollment: 50
Study Start Date: January 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TSW-HP
TSW-HP Intervention implemented by a cognitive specialist over a 6-month treatment period which includes 24 hours (1 hour per week) of facilitated cognitive exercise sessions, which will be supplemented by approximately 24 hours of home practice sessions on a tablet computer.
Behavioral: TSW-HP
TSW-HP involves home practice of cognitive exercises along with the training sessions facilitated by the cognitive specialist at the agency.
Active Comparator: TSW-T
Participants assigned to traditional TSW will receive the usual TSW program, which includes a one hour cognitive exercise practice session per week at Brooklyn Community Services (BCS) for 6 months. This group will not receive home based cognitive practice exercises.
Behavioral: TSW-T
Participants assigned to traditional TSW will receive the usual TSW program which includes a one hour session per week at BCS for 6 months. This group will not receive home based cognitive practice exercises

Detailed Description:

The Thinking Skills for Work (TSW) program has been shown to improve cognitive functioning and work in multiple studies in a variety of vocational programs. TSW includes agency-based, computer cognitive practice facilitated by a cognitive specialist, and teaching of compensatory strategies to manage cognitive challenges, which are integrated with vocational services. Supplementing agency-based practice with home practice on a tablet addresses the need and desire for more cognitive practice, which is expected to further improve cognitive and work outcomes.

This randomized controlled trial will evaluate the impact of supplementing the traditional TSW cognitive practice with home based practice of cognitive exercises using a tablet.. Fifty clients enrolled in vocational services at Brooklyn Community Services will be recruited and randomized either to TSW-Home Practice (N=25) or traditional TSW (N=25).

All the participants will be assessed at baseline, 6 months and 12 months on cognitive functioning and symptoms; work activity will be tracked for 12 months; program satisfaction will be assessed at 6 and 12 months. The study will establish the efficacy of using home practice on a tablet to increase the number of computer cognitive practice exercises completed by clients.

Study hypotheses: 1) Individuals assigned to TSW HP will complete more cognitive practice sessions using COGPACK software than those assigned to traditional TSW; 2) Individuals who are exposed to TSW HP (i.e., complete 6 or more cognitive practice sessions) will complete more practice sessions than those who are exposed to traditional TSW; 3) Individuals assigned to TSW - HP will show greater improvements in cognitive functioning at post treatment and follow up than those assigned to traditional TSW; 4) Individuals assigned to TSW - HP will show greater improvements in work related outcomes (number of job interviews, % obtaining competitive work, weeks worked, wages earned) at post-treatment and follow up than those assigned to traditional TSW.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

age 18 years or older; severe mental illness based on New York State Office of Mental Health criteria; not competitively employed but want to work; enrolled in vocational rehabilitation at Brooklyn Community Services; fluent in English.

Exclusion Criteria:

prior receipt of more than 3 sessions of Thinking Skills for Work (TSW) Cognitive Remediation; medical disorder with known effects on cognitive functioning; inability to give informed consent.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03005574

Contacts
Contact: Susan R McGurk, PhD 617- 353-3549 mcgurk@bu.edu

Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Susan R McGurk, PhD Boston University
  More Information

Responsible Party: Susan Mcgurk, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT03005574     History of Changes
Other Study ID Numbers: 4391 
Study First Received: December 26, 2016
Last Updated: January 1, 2017
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Boston University:
Severe Mental Illness
Cognitive Remediation
Employment

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Depressive Disorder, Major
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders

ClinicalTrials.gov processed this record on January 17, 2017