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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TSW-HP
TSW-T
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Severe Mental Illness, Cognitive Remediation, Employment

Eligibility Criteria

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

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.

Sites / Locations

  • Brooklyn Community ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TSW-HP

TSW-T

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite Measure of Change in Neurocognitive Functioning
Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery

Secondary Outcome Measures

Full Information

First Posted
December 26, 2016
Last Updated
January 23, 2019
Sponsor
Boston University Charles River Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03005574
Brief Title
Comparing Thinking Skills for Work (TSW)Home Practice Program With Traditional TSW Program
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression
Keywords
Severe Mental Illness, Cognitive Remediation, Employment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TSW-HP
Arm Type
Experimental
Arm Description
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.
Arm Title
TSW-T
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TSW-HP
Intervention Description
TSW-HP involves home practice of cognitive exercises along with the training sessions facilitated by the cognitive specialist at the agency.
Intervention Type
Behavioral
Intervention Name(s)
TSW-T
Intervention Description
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
Primary Outcome Measure Information:
Title
Composite Measure of Change in Neurocognitive Functioning
Description
Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan R McGurk, PhD
Phone
617- 353-3549
Email
mcgurk@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan R McGurk, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooklyn Community Services
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Querbach

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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