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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03005574
• Other study ID #: 4391
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Boston University Charles River Campus
• Contact: Susan R McGurk, PhD
• Phone: 617- 353-3549
• Email: mcgurk[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• TSW-HP
TSW-HP involves home practice of cognitive exercises along with the training sessions facilitated by the cognitive specialist at the agency.
• 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

Locations

Country	Name	City	State
United States	Brooklyn Community Services	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Measure of Change in Neurocognitive Functioning	Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery	6 months and 12 months