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

Not Applicable

Completed

• Conditions: Brain Injuries
• Interventions: Other: Goal Management Training; Other: Brain Health Workshop

• Registration Number: NCT02692352
• Lead Sponsor: Sunnaas Rehabilitation Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-02
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-25
• Last Update Submitted: 2016-02-25
• Study First Posted: 2016-02-26
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Goal Management Training	8 sessions of Goal Management Training
Active control group	Brain Health Workshop	8 sessions of Brain Health Workshop

Primary Outcome Measures

Name	Time	Method
Executive functioning in daily life measured by self report questionnaire	one year	Behavior Rating Inventory Executive Functions Adult version
Executive functioning measured by neuropsychological assessment	one year	Conners Continous Performance Test