Acquired Brain InjuryNCT06604000
Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury
A study testing GMT Usual, GMT Cuing and GMT Boost in people with Acquired Brain Injury and Executive Function Disorder, run by St. Olavs Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Brain Injury, Executive Function Disorder
- What is being tested?
- GMT Usual, GMT Cuing and GMT Boost
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteNorway
- Study dates
- 26 Sep 2023to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
St. Olavs Hospital
Trondheim, 7030
Alexander Olsen, PhD, +4791722824, alexander.olsen@ntnu.no
alexander.olsen@ntnu.no
About this study
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)?
Read more
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.
Read the detailed description
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. Data will be analyzed based on an intention-to-treat approach. Penalized linear regression by the elastic net approach (a combination of the Lasso and Ridge regression approaches) will be used to identify demographic, clinical and cognitive predictors of outcome at 6 months after treatment (T3), which is the primary aim of the study. For the secondary aim of investigating the differences in outcome for primary and secondary outcomes between "GMT Cuing" and "GMT Usual", and between "GMT Boost" and "GMT No Boost", linear mixed models (LMMs) will be used. Data for all time points will be included, but of primary interest are differences at T2 (immediately after treatment) for assessing the effect of cuing, and at T3 (6 months after treatment) for the effect of boosting. The LMMs can account for within-subject correlations due to repeated measurements. In addition, the investigators will perform exploratory moderation and mediation analyses across both treatment groups. For the penalized regression models, complete case analyses will be performed as long as the number of missing observations is small. Otherwise, imputation will be considered, but imputation is not straightforward for variable selection models. Linear mixed models can handle missing data for the outcome variable. Considering multiple testing linked to several secondary outcomes, p-values will be interpreted with care rather than using a formal p-value adjustment. Results will be interpreted according to the magnitude of the group difference (effect size) as well as the p-values. Data will be analyzed using IBM SPSS, STATA and R.
- Conditions
- Acquired Brain Injury, Executive Function Disorder
- Being tested
- GMT Usual, GMT Cuing, GMT Boost
- Keywords
- acquired brain injury, goal management training, executive function, cognitive control, GMT, cognitive rehabilitation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMT UsualBehavioural
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.
GMT CuingBehavioural
The participants will 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 (as in "GMT Usual"), on a daily basis receive a message that says "STOP" as a reminder to do their home assignments. An sms with the the text "STOP"; as a reminder everyday from the third session until the fifth session. The message is pseudorandomly sent on different timepoints ranging from 11am to 8pm, including in weekends.
GMT BoostBehavioural
After completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, the participants will receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response.
| Study group | Role | What they receive |
|---|---|---|
| GMT Usual (+ GMT No Boost) | Active comparator | 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. Receives: Behavioral: GMT Usual |
| GMT Usual + GMT Boost | Experimental | 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. After completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, the participants will receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. Receives: Behavioral: GMT Usual; Behavioral: GMT Boost |
| GMT Usual + GMT Cuing (+ GMT No Boost) | Experimental | 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. In this arm participants will also 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 (as in "GMT Usual"), on a daily basis receive a message that says "STOP" as a reminder to do their home assignments. An sms with the the text "STOP" as a reminder everyday from the third session until the fifth session. The message is pseudorandomly sent on different timepoints ranging from 11am to 8pm, including in weekends. Receives: Behavioral: GMT Usual; Behavioral: GMT Cuing |
| GMT Usual + GMT Cuing + GMT Boost | Experimental | Participants will receive GMT Usual + GMT Cuing (see description above). In this arm, after completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, the participants will also receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. Receives: Behavioral: GMT Usual; Behavioral: GMT Cuing; Behavioral: GMT Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Global Executive Composite score from BRIEF-A
Assessed with the Behavior Rating Inventory of Executive Function for Adults (BREIF-A), a 75 item questionnaire that that captures views of an adult\'s executive functions or self- regulation in his or her everyday environment. Items are rated on a 3-point scale (Never a problem - sometimes a problem - often a problem).
Range:70-210. Higher score indicate greater executive dysfunction.
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Secondary outcomes (25)
Conners Continuous Performance Test -III (CPT-III)
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Wechslers Adult Inteligence Scale IV (WAIS-IV): Block Design
Measured: Baseline
Wechslers Adult Inteligence Scale IV (WAIS-IV): Matrix
Measured: Baseline
Wechslers Adult Inteligence Scale IV (WAIS-IV): Vocabulary
Measured: Baseline
Wechslers Adult Inteligence Scale IV (WAIS-IV): Similarities
Measured: Baseline
California Verbal Learning Test 2 (CVLT-2)
Measured: Baseline
Rey Complex Figure Test (Rey-O)
Measured: Baseline
Behavior rating Inventory of Executive function (BRIEF-A): significant other
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Tower
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Trail Making Test (TMT)
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Word Fluency
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Stroop Color-Word Interference Test
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Hopkins Symptom Checklist
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Achenbach System of Empirically Based Assessment (ASEBA): adult self-report
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Achenbach System of Empirically Based Assessment (ASEBA): adult behavior checklist (ABCL)
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Resilience Scale for Adults
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
The Metacognition questionnaire (MCQ-30)
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
SF-12
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Pittsburg Sleep Quality Index
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Insomnia Severity Index
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Epworth Sleepiness Scale
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Fatigue Severity Scale
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Community Integration Questionnaire
Measured: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Group Session Rating Scale (GSRS)
Measured: After each "GMT usual" treatment session (5 times throughout 5-weeks) and after the booster session ("GMT boost" at 3 months after last "GMT usual" session)
Week to week change rating scale ORS
Measured: After each "GMT usual" treatment session (5 times throughout 5-weeks) and after the booster session ("GMT boost" at 3 months after last "GMT usual" session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Sep 2023
- Primary completion18 Dec 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Alexander Olsen, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604000
- Sponsor's protocol ID
- 62983
- Status last verified
- Dec 2025
- First submitted
- 13 Aug 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data cannot be shared in this study due to laws and regulations in Norway.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06604000
- Acronym / sponsor ID
- 62983
- Conditions
- Acquired Brain Injury, Executive Function Disorder
- Keywords
- acquired brain injury, goal management training, executive function, cognitive control, GMT, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 18 Dec 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Data will be analyzed based on an intention-to-treat approach. Penalized linear regression by the elastic net approach (a combination of the Lasso and Ridge regression approaches) will be used to identify demographic, clinical and cognitive predictors of outcome at 6 months after treatment (T3), which is the primary aim of the study. For the secondary aim of investigating the differences in outcome for primary and secondary outcomes between "GMT Cuing" and "GMT Usual", and between "GMT Boost" and "GMT No Boost", linear mixed models (LMMs) will be used. Data for all time points will be included, but of primary interest are differences at T2 (immediately after treatment) for assessing the effect of cuing, and at T3 (6 months after treatment) for the effect of boosting. The LMMs can account for within-subject correlations due to repeated measurements. In addition, the investigators will perform exploratory moderation and mediation analyses across both treatment groups. For the penalized regression models, complete case analyses will be performed as long as the number of missing observations is small. Otherwise, imputation will be considered, but imputation is not straightforward for variable selection models. Linear mixed models can handle missing data for the outcome variable. Considering multiple testing linked to several secondary outcomes, p-values will be interpreted with care rather than using a formal p-value adjustment. Results will be interpreted according to the magnitude of the group difference (effect size) as well as the p-values. Data will be analyzed using IBM SPSS, STATA and R.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GMT Usual (+ GMT No Boost) | Active comparator | Behavioral: GMT UsualParticipants 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. |
| GMT Usual + GMT Boost | Experimental | Behavioral: GMT Usual, Behavioral: GMT BoostParticipants 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. After completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, the participants will receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. |
| GMT Usual + GMT Cuing (+ GMT No Boost) | Experimental | Behavioral: GMT Usual, Behavioral: GMT CuingParticipants 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. In this arm participants will also 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 (as in "GMT Usual"), on a daily basis receive a message that says "STOP" as a reminder to do their home assignments. An sms with the the text "STOP" as a reminder everyday from the third session until the fifth session. The message is pseudorandomly sent on different timepoints ranging from 11am to 8pm, including in weekends. |
| GMT Usual + GMT Cuing + GMT Boost | Experimental | Behavioral: GMT Usual, Behavioral: GMT Cuing, Behavioral: GMT BoostParticipants will receive GMT Usual + GMT Cuing (see description above). In this arm, after completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, the participants will also receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMT UsualParticipants 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. | Behavioural | GMT Usual (+ GMT No Boost), GMT Usual + GMT Boost, GMT Usual + GMT Cuing (+ GMT No Boost), GMT Usual + GMT Cuing + GMT Boost |
| GMT CuingThe participants will 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 (as in "GMT Usual"), on a daily basis receive a message that says "STOP" as a reminder to do their home assignments. An sms with the the text "STOP"; as a reminder everyday from the third session until the fifth session. The message is pseudorandomly sent on different timepoints ranging from 11am to 8pm, including in weekends. | Behavioural | GMT Usual + GMT Cuing (+ GMT No Boost), GMT Usual + GMT Cuing + GMT Boost |
| GMT BoostAfter completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, the participants will receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. | Behavioural | GMT Usual + GMT Boost, GMT Usual + GMT Cuing + GMT Boost |
Primary outcome
The Global Executive Composite score from BRIEF-A
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Assessed with the Behavior Rating Inventory of Executive Function for Adults (BREIF-A), a 75 item questionnaire that that captures views of an adult\'s executive functions or self- regulation in his or her everyday environment. Items are rated on a 3-point scale (Never a problem - sometimes a problem - often a problem). Range:70-210. Higher score indicate greater executive dysfunction.
25 secondary outcomes
Conners Continuous Performance Test -III (CPT-III)
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Wechslers Adult Inteligence Scale IV (WAIS-IV): Block Design
Time frame: Baseline
Wechslers Adult Inteligence Scale IV (WAIS-IV): Matrix
Time frame: Baseline
Wechslers Adult Inteligence Scale IV (WAIS-IV): Vocabulary
Time frame: Baseline
Wechslers Adult Inteligence Scale IV (WAIS-IV): Similarities
Time frame: Baseline
California Verbal Learning Test 2 (CVLT-2)
Time frame: Baseline
Rey Complex Figure Test (Rey-O)
Time frame: Baseline
Behavior rating Inventory of Executive function (BRIEF-A): significant other
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Tower
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Trail Making Test (TMT)
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Word Fluency
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
D-KEFS: Stroop Color-Word Interference Test
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Hopkins Symptom Checklist
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Achenbach System of Empirically Based Assessment (ASEBA): adult self-report
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Achenbach System of Empirically Based Assessment (ASEBA): adult behavior checklist (ABCL)
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Resilience Scale for Adults
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
The Metacognition questionnaire (MCQ-30)
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
SF-12
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Pittsburg Sleep Quality Index
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Insomnia Severity Index
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Epworth Sleepiness Scale
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Fatigue Severity Scale
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Community Integration Questionnaire
Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment
Group Session Rating Scale (GSRS)
Time frame: After each "GMT usual" treatment session (5 times throughout 5-weeks) and after the booster session ("GMT boost" at 3 months after last "GMT usual" session)
Week to week change rating scale ORS
Time frame: After each "GMT usual" treatment session (5 times throughout 5-weeks) and after the booster session ("GMT boost" at 3 months after last "GMT usual" session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Individual patient data cannot be shared in this study due to laws and regulations in Norway.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Olsen principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMT Usual, GMT Cuing and GMT Boost in people with Acquired Brain Injury and Executive Function Disorder, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Olsen, PhD (+4791722824, alexander.olsen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Global Executive Composite score from BRIEF-A (time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.