Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-06-30

Brief Summary

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The main objective of this study is to examine the effect of Goal Management Training for patients with executive difficulties after acquired brain injury in a randomized controlled trial. The effect on cognitive functioning will be examined, as will the relationship between treatment effects and lesion location and size. The effect of Goal Management training on regulating emotions, quality of life and coping will be examined. The generalizability of treatment effects across etiologies will be explored by comparing effects in three patient groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors. Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity will be used to establish detailed lesion descriptions. Functional MRI data will provide information on the neural underpinnings of treatment related change. A secondary objective is to expand the Goal Management Training protocol with increased focus on emotional regulation and adherence to homework assignment.

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Detailed Description

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Conditions

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Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental

8 sessions of Goal Management Training

Group Type EXPERIMENTAL

Goal Management Training

Intervention Type OTHER

Goal Management training, 8 sessions of 2 hours

Active control group

8 sessions of Brain Health Workshop

Group Type ACTIVE_COMPARATOR

Brain Health Workshop

Intervention Type OTHER

Brain Health Workshop training, 8 sessions of 2 hours

Interventions

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Goal Management Training

Goal Management training, 8 sessions of 2 hours

Intervention Type OTHER

Brain Health Workshop

Brain Health Workshop training, 8 sessions of 2 hours

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Traumatic Brain Injury, stroke and resected brain tumor patients with no concomitant diseases
* Minimum 6 months post-injury/surgery
* Reporting executive problems by structured interview or baseline assessment (cognitive performance measures)

Exclusion Criteria

* Major psychiatric disorder or reported ongoing alcohol or substance abuse
* Premorbid neurological disease or insult and/or comorbid neurological disease
* Aphasia or other specified language problems causing potential communication problems
* Impaired basic cognitive, linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training

Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No