Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

January 26, 2015 updated by: Deirdre Dawson, Baycrest

Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach

Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Executive dysfunction is endemic after severe acquired brain injuries (ABIs) and is highly associated with long-lasting psychosocial distress, problems in a multiplicity of everyday activities and overall reduced quality of life. There is increasing evidence to suggest that a novel behavioral intervention is a treatment of choice for executive dysfunction. However few studies have addressed ecological relevance: failing to take into account the significant impact of the complex settings of real life on executive function. More data are desperately needed in this area given the devastating consequences of ABI. We propose to investigate the benefits of two community- based interventions.

Study Type

Interventional

Enrollment (Actual)

95

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 Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A2E1
        • Baycrest Centre for Geriatric Care

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:

  • fluent in written and spoken English,
  • have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke,

Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional rehabilitation
In-home work on problems in daily living.
Behavioral: Conventional rehabilitation.
1 hour / 2x / week for up to 15 sessions
Experimental: Novel rehabilitation approach
Behavioral: Novel rehabilitation approach
1 hr, 2x/week for up to 15 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in performance on COPM
Time Frame: pre, post, 3 month follow-up
Canadian Occupational Performance Measure: standardized interview
pre, post, 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DEX, IADL profile
Time Frame: pre, post, 3 month follow-up
Perceived and observed impact of dysexecutive syndrome in everyday life
pre, post, 3 month follow-up

Collaborators and Investigators

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

Sponsor

Baycrest

Investigators

  • Principal Investigator: Deirdre D Dawson, PhD, Baycrest centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB1120

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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