CClinicalTrials.gg
CompletedNCT02692352Updated Feb 26, 2016

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

An interventional study of Goal Management Training and Brain Health Workshop in Brain Injuries, sponsored by Sunnaas Rehabilitation Hospital. Completed. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Sunnaas Rehabilitation Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Injuries
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 70 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Sunnaas Rehabilitation Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Experimental

    8 sessions of Goal Management Training

    Other: Goal Management Training

  • Active comparator
    Active control group

    8 sessions of Brain Health Workshop

    Other: Brain Health Workshop

Interventions

  • OtherGoal Management Training

    Goal Management training, 8 sessions of 2 hours

  • OtherBrain Health Workshop

    Brain Health Workshop training, 8 sessions of 2 hours

06

What researchers measure

Primary outcomes

  1. Executive functioning in daily life measured by self report questionnaire

    Behavior Rating Inventory Executive Functions Adult version

    Time frame: one year

  2. Executive functioning measured by neuropsychological assessment

    Conners Continous Performance Test

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 36002956 ↗
  • 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. PubMed 27424292 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02692352
Lead sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Oslo, University of Glasgow, Oslo University Hospital
Responsible party
Sveinung Tornaas (Principal investigator, Sunnaas Rehabilitation Hospital) — Principal investigator
First posted
Feb 26, 2016
Start date
Aug 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Feb 26, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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