Actively Recruiting
Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury
Led by St. Olavs Hospital · Updated on 2025-12-02
116
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
N
Norwegian University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate predictors of treatment outcome, and the effect of individual treatment components of Goal Management Training (GMT) for improvement of cognitive control function in people with acquired brain injury (ABI). Primary aim: To identify demographic, clinical and cognitive predictors of treatment response in Goal Management Training after acquired brain injury (ABI)? Secondary aims: To investigate the effects of a) extended cuing (via a smartphone) and b) a booster module? * All included participants will receive Goal Management Training in groups of 4-6 patients, as implemented in a rehabilitation hospital setting (St. Olavs Hospital, Trondheim University Hospital). The standard treatment ("GMT Usual") consists of 10 sessions, delivered as 2 sessions a day, one day per week, over 5 weeks. * All participants will be asked to complete self-report measures and performance-based cognitive testing at baseline (T1), immediately after the main treatment period (T2), at 6 months (T3), and 1 year (T4) after treatment. * After baseline assessment, 50% of participants will be randomized to receive extended cuing through a smartphone application ("GMT Cuing") - intended to facilitate the effect of between-session tasks (homework) completed by the participants. These participants will, in addition to the standard treatment, on a daily basis receive a message that says "STOP" as a reminder to do their home assignments. * After completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, 50% of the participants will be randomized to receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. The remaining 50% will receive no booster module ("GMT No Boost") * Randomization will be carried out on treatment group-level (all patients in the same group receive the same treatment). The total anticipated sample size is N = 116 patients. * The Global Executive Composite (GEC) score derived from BRIEF-A will be used as the primary outcome measure. A selection of other included measures will be used as secondary outcome measures.
CONDITIONS
Official Title
Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18-65 with acquired brain injury with no concomitant diseases minimum 12 months post-injury or surgery
- Reporting cognitive control problems by structured interview or clinical performance measures
You will not qualify if you...
- Non-fluency in Norwegian language
- Major psychiatric disorder or ongoing alcohol or substance abuse
- Premorbid neurological disease or insult and/or comorbid neurological disease
- Aphasia or other language problems causing communication difficulties
- Impaired basic linguistic, memory, motor, or perceptual function that interferes with training or estimated IQ less than 85
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Olavs Hospital
Trondheim, Norway, 7030
Actively Recruiting
Research Team
A
Alexander Olsen, PhD
CONTACT
J
Janne-Birgitte Børke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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