Cognitive Training to Enhance VA Work Program Outcomes

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether augmenting work services with cognitive remediation can improve vocational outcomes for psychiatrically disabled participants in VA work services.

Clinical Trial Description

Background: Our previous RR&D funded study demonstrated significantly better vocational outcomes for people with schizophrenia when cognitive training supplemented their participation in Incentive Therapy. We have found in a subsequent NIMH funded study involving cognitive training and supported employment that competitive employment outcomes were better for those who received cognitive training. Moreover, we found that patients with the poorest community function at intake were very unlikely to obtain competitive employment unless they received the cognitive training. The current study will test the effectiveness of cognitive training by extending it to a broader range of VA patients with psychotic disorders participating in all types of VA work services currently available, including Incentive Therapy, Compensated Work Therapy, and Supported Employment. We plan to offer it to any patient with a psychotic disorder who is unlikely to obtain competitive employment without additional services. We will also compare two types of cognitive training to determine whether cognitive game software works as well narrowly focused cognitive exercises.

Design and Method: This is a randomized clinical trial in which 80 VA patients referred for VA work services and who meet criteria for psychotic disorder and impaired community function will be randomized to one of two types of cognitive training. There will be two conditions with approximately 40 subjects per condition. Intake procedures will include psychosocial, neuropsychological, and psychiatric assessments. These assessments will be repeated at 6-months and 12 month follow-up. Cognitive training will consist of computer-based cognitive exercises of attention, memory and problem-solving and a weekly group that focuses on improving work behaviors. One of the computer-based systems employs engaging cognitive game software and the other uses specially designed exercises that narrowly focus on discrete cognitive processes. Work services will be provided as usual to both conditions. Primary endpoints are measures of productive activity including obtaining competitive employment, total hours worked, and money earned. Secondary endpoints include neuropsychological, quality of life and health status changes. The study will be for three years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00829400
Study type	Interventional
Source	VA Connecticut Healthcare System
Contact
Status	Completed
Phase	N/A
Start date	May 2008
Completion date	December 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.