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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692352
• Other study ID #: 2011/2/0204
• Status: Completed
• Phase: N/A
• First received: February 23, 2016
• Last updated: February 25, 2016
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Other:
• Goal Management Training
Goal Management training, 8 sessions of 2 hours
• Brain Health Workshop
Brain Health Workshop training, 8 sessions of 2 hours

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	Oslo University Hospital, University of Glasgow, University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive functioning in daily life measured by self report questionnaire	Behavior Rating Inventory Executive Functions Adult version	one year	No
Primary	Executive functioning measured by neuropsychological assessment	Conners Continous Performance Test	one year	No