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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSt. Olavs Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

116 Participants
are divided into 4 treatment groups
Group A: GMT Usual (+ GMT No Boost)Active comparator 1 intervention
Group B: GMT Usual + GMT BoostExperimental treatment 2 interventions
Group C: GMT Usual + GMT Cuing (+ GMT No Boost)Experimental treatment 2 interventions
Group D: GMT Usual + GMT Cuing + GMT BoostExperimental treatment 3 interventions

Trial outcomes

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.

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator