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NCT Number: NCT06604000

Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GMT Usual

Behavioral

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 Cuing

Behavioral

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 Boost

Behavioral

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.

Primary outcomes

  1. 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&#39;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.

Secondary outcomes

  1. Conners Continuous Performance Test -III (CPT-III)

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  2. Wechslers Adult Inteligence Scale IV (WAIS-IV): Block Design

    Time frame: Baseline

  3. Wechslers Adult Inteligence Scale IV (WAIS-IV): Matrix

    Time frame: Baseline

  4. Wechslers Adult Inteligence Scale IV (WAIS-IV): Vocabulary

    Time frame: Baseline

  5. Wechslers Adult Inteligence Scale IV (WAIS-IV): Similarities

    Time frame: Baseline

  6. California Verbal Learning Test 2 (CVLT-2)

    Time frame: Baseline

  7. Rey Complex Figure Test (Rey-O)

    Time frame: Baseline

  8. Behavior rating Inventory of Executive function (BRIEF-A): significant other

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  9. D-KEFS: Tower

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  10. D-KEFS: Trail Making Test (TMT)

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  11. D-KEFS: Word Fluency

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  12. D-KEFS: Stroop Color-Word Interference Test

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  13. Hopkins Symptom Checklist

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  14. Achenbach System of Empirically Based Assessment (ASEBA): adult self-report

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  15. Achenbach System of Empirically Based Assessment (ASEBA): adult behavior checklist (ABCL)

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  16. Resilience Scale for Adults

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  17. The Metacognition questionnaire (MCQ-30)

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  18. SF-12

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  19. Pittsburg Sleep Quality Index

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  20. Insomnia Severity Index

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  21. Epworth Sleepiness Scale

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  22. Fatigue Severity Scale

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  23. Community Integration Questionnaire

    Time frame: Baseline, Immediately after treatment, 6 months and 1 year after treatment

  24. 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)

  25. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Olsen, PhD

CONTACT

[email protected]

+4791722824

Janne-Birgitte Børke

CONTACT

[email protected]

41283909

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Sep 19, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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