NCT02692352

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

February 23, 2016

Last Update Submit

February 25, 2016

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (2)

  • Executive functioning in daily life measured by self report questionnaire

    Behavior Rating Inventory Executive Functions Adult version

    one year

  • Executive functioning measured by neuropsychological assessment

    Conners Continous Performance Test

    one year

Study Arms (2)

Experimental

EXPERIMENTAL

8 sessions of Goal Management Training

Other: Goal Management Training

Active control group

ACTIVE COMPARATOR

8 sessions of Brain Health Workshop

Other: Brain Health Workshop

Interventions

Goal Management TrainingOTHER

Goal Management training, 8 sessions of 2 hours

Experimental
Brain Health WorkshopOTHER

Brain Health Workshop training, 8 sessions of 2 hours

Active control group

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 36002956DERIVED

  • 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.

    PMID: 27424292DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 26, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share