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

January 23, 2019 updated by: Susan Mcgurk, Boston University Charles River Campus

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Susan R McGurk, PhD
  • Phone Number: 617- 353-3549
  • Email: mcgurk@bu.edu

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11236
        • Recruiting
        • Brooklyn Community Services
        • Contact:
          • Jodi Querbach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Measure of Change in Neurocognitive Functioning
Time Frame: 6 months and 12 months
Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Investigators

  • Principal Investigator: Susan R McGurk, PhD, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

December 26, 2016

First Posted (ESTIMATE)

December 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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