Cognitive Rehabilitation of Executive Dysfunction With the Goal Management Training (GMT) - Exploring Variations in Mode of Administration, Frequency and Intensity.
NCT07924774, Not applicable, Recruiting, Karolinska Institutet
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Rehabilitation of Executive Dysfunction With the Goal Management Training (GMT) - Exploring Variations in Mode of Administration, Frequency and Intensity. | ClinicalTrials.gov |
| NCT number | NCT07924774 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Karolinska Institutet | ClinicalTrials.gov |
| Conditions | Acquired Brain Injury (Including Stroke), Chronic Pain | ClinicalTrials.gov |
| Interventions | Goal Management Training (GMT) | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change following Goal Management Training in participant-reported everyday executive difficulties over the follow-up period measured with the Dysexecutive Questionnaire (DEX) | Change over time will be evaluated using assessments conducted at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up. | Everyday executive difficulties are assessed using the participant-reported Dysexecutive Questionnaire from the Behavioural Assessment of the Dysexecutive Syndrome. The 20-item questionnaire assesses cognitive, behavioral, and emotional manifestations of executive dysfunction in everyday life. The total score ranges from 0 to 60, with higher scores indicating greater executive difficulties. | ClinicalTrials.gov |
| Secondary | Change in Attainment of Individual Rehabilitation Goals with Goal Attainment Scale (GAS), Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Attainment of individually defined rehabilitation goals is assessed using Goal Attainment Scaling. Before the intervention, individualized goals and levels of expected attainment are defined using a five-level scale ranging from -2 to +2, where 0 represents the expected level of goal attainment, negative values represent outcomes below the expected level, and positive values represent outcomes above the expected level. The primary GAS metric reported will be iterative GAS T-score. Higher scores indicate greater attainment of the predefined rehabilitation goals. | ClinicalTrials.gov |
| Secondary | Change in functional ability, adjustment, and participation with the Mayo-Portland Adaptability Inventory-4 (MPAI-4) following Goal Management Training. | Change over time will be evaluated using assessments conducted at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up. | Functional outcome is assessed using the Mayo-Portland Adaptability Inventory-4, total score. The inventory assesses ability, adjustment, and participation following acquired brain injury. The total score will be calculated and transformed according to the standardized scoring procedure, with higher scores indicating greater limitations. | ClinicalTrials.gov |
| Secondary | Change following Goal Management Training in informant-reported everyday executive difficulties over the follow-up period measured with the Dysexecutive Questionnaire for informants (DEX) | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Everyday executive difficulties are assessed using the informant-reported Dysexecutive Questionnaire from the Behavioural Assessment of the Dysexecutive Syndrome. The 20-item questionnaire assesses cognitive, behavioral, and emotional manifestations of executive dysfunction in everyday life. The total score ranges from 0 to 60, with higher scores indicating greater executive difficulties. | ClinicalTrials.gov |
| Secondary | Change in Observed Work Performance with Assessment of Work Performance (AWP) Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | The Assessment of Work Performance (AWP) is a standardized observation-based instrument used to assess an individual's work skills during the performance of a work activity. It evaluates 14 items divided into three subdomains (motor skills, process skills, communication/interaction skills). Items are scored on a 4-point ordinal scale ranging from 1 (Incompetent performance) to 4 (Competent performance), thus ranging from 14 to 56, with higher scores indicating better observed work performance. To allow for precise linear measurement and to demonstrate a targeted intervention effect, raw ordinal scores are converted into interval-scale Logit values using Rasch analysis. The intervention effect will be evaluated on two levels: 1. Total Score Change (increase in overall Logit value indicates improvement) 2. Subdomain Profile Changes | ClinicalTrials.gov |
| Secondary | Change in Self-Rated Occupational Performance and satisfaction with performance Following with Canadian Occupational Perfomrance Measure (COPM) Goal Management Training | Baseline and immediately after completion of Goal Management Training | Self-rated occupational performance is assessed using the Canadian Occupational Performance Measure. Participants identify activities that are important to them and rate their current performance and satisfaction of performance of the selected activities on a scale from 1 to 10, with higher scores indicating better perceived performance nad satisfaction with perfomrance respectively. The outcome is the mean performance rating across the activities selected for reassessment. | ClinicalTrials.gov |
| Secondary | Change in Executive Attention and Working Memory Measured With the Paced Auditory Serial Addition Test (PASAT) Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Executive attention and working memory are assessed using the Paced Auditory Serial Addition Test. The prespecified outcome is number of correct responses and standardized score for the PASAT version A (presentation rate 2,4 sec) and version C (presentation rate 1,8 sec). Scores range from 0 to 60, with higher scores indicating better performance. | ClinicalTrials.gov |
| Secondary | Change in Inhibitory Control and Cognitive Flexibility Measured With the D-KEFS Color-Word Interference Test Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Inhibitory control and Cognitve Flexibility is assessed using the Color-Word Interference Test from the Delis-Kaplan Executive Function System. The prespecified outcome is completion time including scaled and error score for conditions 3 (Inhibition) and 4 (Inhibition-Switching). Performance is measured by completion time (in seconds) and error rates. Raw scores are converted to standardized scaled scores (normative mean = 10, SD = 3). Higher scaled scores indicate better executive functioning, whereas higher raw scores (more seconds used) indicate poorer performance. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Visual-Motor Sequencing and Set-Shifting (D-KEFS Trail Making Test) | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | The D-KEFS Trail Making Test evaluates visual scanning, motor speed, and executive set-shifting across 5 conditions (Visual Scanning, Number Sequencing, Letter Sequencing, Number-Letter Switching, and Motor Speed). Raw scores (completion time in seconds) for each condition, as well as contrast scores, are converted into age-corrected scaled scores based on normative data. Scaled scores range from 1 to 19, with higher scores indicating better performance (i.e., faster processing speed and superior set-shifting flexibility). | ClinicalTrials.gov |
| Secondary | Change in Verbal Phonemic and Semantic Fluency and Cognitive Flexibility Measured With the D-KEFS Verbal Fluency Test Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | The D-KEFS Verbal Fluency Test assesses fluent productivity in the verbal domain under specific executive constraints. It consists of 3 conditions: Letter Fluency (phonemic), Category Fluency (semantic), and Category Switching. Performance is measured by the total number of correct words generated within designated time limits (typically 60 seconds per trial). Raw counts are converted into age-corrected scaled scores. Scaled scores range from 1 to 19, with higher scores indicating better verbal fluency and cognitive flexibility. | ClinicalTrials.gov |
| Secondary | Change in Processing Speed and Attention including Performance Fatigability Measured With the WAIS-IV NI Coding Subtest From Baseline to Follow-Up | Baseline and and at 6 months and 12 months after completion of Goal Management Training | Processing speed and sustained visual attention are assessed using the Coding subtest from the Wechsler Adult Intelligence Scale-Fourth Edition Neuropsychological Instrument. The prespecified outcome is raw and scaled total score, ranging from 0-135, with higher scores indicating better performance, Incidental Learning (Free Recall) (0-9), Incidental Learning (Pairing) (0-18), and Interval Discrepancy (raw difference in correct stimuli between the first 30 seconds and the last 30 seconds of the test (ranging from -15 to +15; negative scores indicate fatigue, while positive scores indicate a beneficial learning curve). | ClinicalTrials.gov |
| Secondary | Change in Mental Fatigue Measured With the Multidimensional Fatigue Inventory (MFI-20)Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Mental fatigue is assessed using the Mental Fatigue subscale of the 20-item Multidimensional Fatigue Inventory. The subscale consists of five items and has a mean score ranging from 4 to 20 per subscale, with higher scores indicating greater mental fatigue. | ClinicalTrials.gov |
| Secondary | Change in Self-Rated Mental Fatigue During Goal Management Training Sessions | Immediately before and after each Goal Management Training session throughout the intervention period of 5, 7, or 9 weeks | Mental fatigue is rated immediately before and immediately after each Goal Management Training session using a visual analogue scale ranging from 0 to 100, where 0 represents no fatigue and 100 mm represents excruciating fatigue. The prespecified outcome is mean within-session change across completed sessions and change in pre-session ratings across the treatment period. | ClinicalTrials.gov |
| Secondary | Change in Self-Rated Pain Discomfort During Goal Management Training Sessions in the Long-Term Pain Cohort | Immediately before and after each Goal Management Training session throughout the intervention period | Pain-related discomfort is rated immediately before and immediately after each Goal Management Training session by participants in the long-term pain cohort using a visual analogue scale ranging from 0 to 100 mm, where 0 represents no pain and 100 represents extreme pain. The prespecified outcome is mean within-session change across completed sessions and change in pre-session ratings across the intervention period. | ClinicalTrials.gov |
| Other | Change in Depression and Anxiety Symptoms Measured With the Hospital Anxiety and Depression Scale Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Symptoms are assessed using the Anxiety and Depression subscale of the Hospital Anxiety and Depression Scale. The scale consists of forteen items (seven items for anxiety, seven items for derpession)and has a total score ranging from 0 to 42, with higher scores indicating more severe symptoms. | ClinicalTrials.gov |
| Other | Change in Global Life Satisfaction Measured With the Life Satisfaction Questionnaire-11 Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Global life satisfaction is assessed using global and domain-specific items (covering Vocation, Financial situation, Leisure, Contact with friends/acquaintances, Sexual life, Activities of daily living (ADL), Family life, Partnership, Physical health, and Psychological health) from the Life Satisfaction Questionnaire-11. The items are rated on a six-point scale ranging from 1 to 6, with higher scores indicating greater life satisfaction. Median Scores (Evaluation of changes in central tendency) and Dichotomized Proportions for Satisfaction Rates (Calculation of the percentage of participants classified as "satisfied" (scores 5-6) versus "not satisfied" (scores 1-4) will be used to track the clinical rate of satisfaction over time. | ClinicalTrials.gov |
| Other | Change in Health-Related Quality of Life Measured With the EQ-5D-3L Health Utility Index Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | The EQ-5D-3L index score is used to evaluate generic health-related quality of life across 5 dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression). The index score is derived by applying the Swedish experience-based Time Trade-Off (TTO) value set to the descriptive profile. The Swedish index scores range from 0.340 to 1.00, where 1.00 represents full health and 0.340 represents the worst possible health state. Higher scores indicate a better health-related quality of life. | ClinicalTrials.gov |
| Other | Change in Self-Rated Health Measured With the EQ Visual Analogue Scale Following Goal Management Training | Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion | Self-rated health is assessed using the EQ Visual Analogue Scale. Scores range from 0 to 100, with 0 representing the worst imaginable health and 100 representing the best imaginable health. | ClinicalTrials.gov |
| Other | Change in Sense of Coherence (SOC-13) From Baseline to 12-Month Follow-Up | Baseline and 12 months after completion of Goal Management Training | Sense of coherence is assessed using the 13-item Sense of Coherence Scale. A total score is calculated by summing the item scores after reverse scoring the applicable items. The total score ranges from 13 to 91, with higher scores indicating a stronger sense of coherence. | ClinicalTrials.gov |
| Other | Change in Self-Rated Mental Fatigue During Neuropsychological Assessment | Immediately before and after neuropsychological assessment at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up | Mental fatigue is rated immediately before and immediately after each neuropsychological assessment using a visual analogue scale ranging from 0 to 100, where 0 represents no fatigue and 100 mm represents excruciating fatigue. The prespecified outcome is the within-assessment change from the pre-assessment rating to the post-assessment rating. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 13
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 10824502 | BACKGROUND | PubMed |
| 23597002 | BACKGROUND | PubMed |
| 26031289 | BACKGROUND | PubMed |
| 26812574 | BACKGROUND | PubMed |
| 28651477 | BACKGROUND | PubMed |
| 29540124 | BACKGROUND | PubMed |
| 30926291 | BACKGROUND | PubMed |
| 31232252 | BACKGROUND | PubMed |
| 36594859 | BACKGROUND | PubMed |
| 36855274 | BACKGROUND | PubMed |
| 39546453 | BACKGROUND | PubMed |
| 40562264 | BACKGROUND | PubMed |
| 42533838 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)