NCT06604000 Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury
| NCT ID | NCT06604000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Olavs Hospital |
| Condition | Acquired Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2023-09-26 |
| Primary Completion | 2029-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2023-09-26 with a primary completion date of 2029-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18-65 with acquired brain injury with no concomitant diseases minimum 12 months' post-injury/surgery, reporting cognitive control problems by structured interview or clinical performance measures. Exclusion Criteria: * Non-fluency in Norwegian Language * 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 linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with training or estimated IQ \< 85
Contact & Investigator
Alexander Olsen
PRINCIPAL INVESTIGATOR
National Taiwan Normal University
Frequently Asked Questions
Who can join the NCT06604000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acquired Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06604000 currently recruiting?
Yes, NCT06604000 is actively recruiting participants. Contact the research team at alexander.olsen@ntnu.no for enrollment information.
Where is the NCT06604000 trial being conducted?
This trial is being conducted at Trondheim, Norway.
Who is sponsoring the NCT06604000 clinical trial?
NCT06604000 is sponsored by St. Olavs Hospital. The principal investigator is Alexander Olsen at National Taiwan Normal University. The trial plans to enroll 116 participants.