NCT03005574

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

December 26, 2016

Last Update Submit

August 5, 2024

Conditions

Keywords

Severe Mental IllnessCognitive RemediationEmployment

Outcome Measures

Primary Outcomes (1)

  • Composite Measure of Change in Neurocognitive Functioning

    Neurocognitive tests for primary outcome variables are from (MATRICS) Consensus Cognitive Battery

    6 months and 12 months

Study Arms (2)

TSW-HP

EXPERIMENTAL

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-T

ACTIVE COMPARATOR

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

Interventions

TSW-HPBEHAVIORAL

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

TSW-HP
TSW-TBEHAVIORAL

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

TSW-T

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooklyn Community Services

Brooklyn, New York, 11236, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepressive Disorder, MajorMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Study Officials

  • Susan R McGurk, PhD

    Boston University

    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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 26, 2016

First Posted

December 29, 2016

Study Start

January 27, 2017

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations