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

NCT06604000 | Recruiting

• 1 other identifier: 62983
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Executive Function Disorder

Keywords

acquired brain injury; goal management training; executive function; cognitive control; GMT; cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Immediately after treatment, 6 months and 1 year after treatment

Secondary Outcomes (25)

• Conners Continuous Performance Test -III (CPT-III)

  Baseline, Immediately after treatment, 6 months and 1 year after treatment

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

  Baseline

• Wechslers Adult Inteligence Scale IV (WAIS-IV): Matrix

  Baseline

• Wechslers Adult Inteligence Scale IV (WAIS-IV): Vocabulary

  Baseline

• Wechslers Adult Inteligence Scale IV (WAIS-IV): Similarities

  Baseline

Study Arms (4)

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.

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.

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.

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.

Behavioral: GMT Usual; Behavioral: GMT Cuing; Behavioral: GMT Boost

Interventions

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 Usual (+ GMT No Boost); GMT Usual + GMT Boost; GMT Usual + GMT Cuing (+ GMT No Boost); GMT Usual + GMT Cuing + GMT Boost

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 Usual + GMT Cuing (+ GMT No Boost); GMT Usual + GMT Cuing + GMT Boost

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.

GMT Usual + GMT Boost; GMT Usual + GMT Cuing + GMT Boost

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St. Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Alexander Olsen

  National Taiwan Normal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Olsen, PhD

CONTACT

+4791722824; alexander.olsen@ntnu.no

Janne-Birgitte Børke

CONTACT

41283909; Janne-Birgitte.Borke@stolav.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: September 19, 2024
• Study Start: September 26, 2023
• Primary Completion (Estimated): December 18, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)