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

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Goal Management Training
Brain Health Workshop
Sponsored by
Sunnaas Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Active control group

    Arm Description

    8 sessions of Goal Management Training

    8 sessions of Brain Health Workshop

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 23, 2016
    Last Updated
    February 25, 2016
    Sponsor
    Sunnaas Rehabilitation Hospital
    Collaborators
    University of Oslo, University of Glasgow, Oslo University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02692352
    Brief Title
    Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury
    Official Title
    Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sunnaas Rehabilitation Hospital
    Collaborators
    University of Oslo, University of Glasgow, Oslo University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    8 sessions of Goal Management Training
    Arm Title
    Active control group
    Arm Type
    Active Comparator
    Arm Description
    8 sessions of Brain Health Workshop
    Intervention Type
    Other
    Intervention Name(s)
    Goal Management Training
    Intervention Description
    Goal Management training, 8 sessions of 2 hours
    Intervention Type
    Other
    Intervention Name(s)
    Brain Health Workshop
    Intervention Description
    Brain Health Workshop training, 8 sessions of 2 hours
    Primary Outcome Measure Information:
    Title
    Executive functioning in daily life measured by self report questionnaire
    Description
    Behavior Rating Inventory Executive Functions Adult version
    Time Frame
    one year
    Title
    Executive functioning measured by neuropsychological assessment
    Description
    Conners Continous Performance Test
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    67 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    36002956
    Citation
    Olsen A, Dennis EL, Stubberud J, Hovenden ES, Solbakk AK, Endestad T, Kristian Hol P, Schanke AK, Lovstad M, Tornas S. Regional brain volume prior to treatment is linked to outcome after cognitive rehabilitation in traumatic brain injury. Neuroimage Clin. 2022;35:103126. doi: 10.1016/j.nicl.2022.103126. Epub 2022 Jul 28.
    Results Reference
    derived
    PubMed Identifier
    27424292
    Citation
    Tornas S, Lovstad M, Solbakk AK, Schanke AK, Stubberud J. Goal Management Training Combined With External Cuing as a Means to Improve Emotional Regulation, Psychological Functioning, and Quality of Life in Patients With Acquired Brain Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Nov;97(11):1841-1852.e3. doi: 10.1016/j.apmr.2016.06.014. Epub 2016 Jul 15.
    Results Reference
    derived

    Learn more about this trial

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

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