An interventional study of Goal Management Training (GMT) in Acquired Brain Injury (Including Stroke) and Chronic Pain, sponsored by Karolinska Institutet. Recruiting at 3 sites in Sweden. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
Executive functions help people initiate, organize, monitor, and complete everyday activities. Difficulties with these functions are common after acquired brain injury and may also occur in people with long-term pain. A person may understand what needs to be done but still have difficulty starting an activity, maintaining focus on the overall goal, monitoring performance, adjusting a plan, or completing the activity. These difficulties can affect independence, rehabilitation, work, studies, family life, and participation in society.
Goal Management Training is a structured cognitive rehabilitation program designed to help people manage goal-directed activities. Participants learn strategies for stopping ongoing or automatic behavior, identifying the current goal, dividing complex activities into manageable steps, monitoring progress, and redirecting attention when they lose track of the goal.
This multicenter study evaluates the implementation and effects of a Swedish version of Goal Management Training in adults with executive difficulties or reduced working memory following acquired brain injury or in association with long-term pain. The program is delivered as part of clinical rehabilitation at participating centers in Sweden.
The study examines whether Goal Management Training can be implemented in different rehabilitation settings and delivered in different clinical formats, including group-based, individually delivered, in-person, and remotely delivered treatment. The choice of format is based on the participant's clinical rehabilitation needs and the conditions at the participating center. Specific program formats in terms of intensity (five-, seven-, and nine-session versions of Goal Management Training), may be evaluated in separate analyses within the overall study.
Changes are assessed in areas including cognitive functioning, everyday executive difficulties, activity, and participation. The study also examines whether improvements are maintained after the intervention and explores differences in patterns of response between participants and treatment formats.
The overall aim is to improve knowledge about how Goal Management Training can be implemented in Swedish rehabilitation services and adapted to different patient groups, clinical settings, and modes of delivery. The findings may contribute to more accessible and individually adapted cognitive rehabilitation for people with acquired brain injury or long-term pain.
Executive functions are higher-order cognitive processes involved in the initiation, planning, execution, monitoring, and adjustment of goal-directed behavior. Executive dysfunction may substantially affect an individual's ability to organize daily activities, maintain focus on intended goals, adapt behavior to changing circumstances, and participate independently in work, education, family life, and other areas of everyday life.
A central manifestation of executive dysfunction is goal neglect, defined as difficulty maintaining and implementing an overarching goal despite adequate comprehension of the task or instruction. An individual may understand and describe what should be done but fail to initiate, sustain, monitor, or appropriately regulate the actions required to achieve the intended goal. This discrepancy between knowledge and implementation can be particularly disabling in complex and unstructured everyday situations.
Goal Management Training (GMT) is a structured, manual-based metacognitive intervention developed to address goal neglect and related executive difficulties. Participants learn to interrupt ongoing or automatic behavior, direct attention to the present situation, define the current goal, divide complex activities into manageable steps, monitor performance, and redirect behavior when actions are no longer aligned with the intended goal. The intervention is intended to promote the application and generalization of cognitive strategies in everyday life.
GMT has been evaluated in several neurological and psychiatric populations, including people with acquired brain injury. It has primarily been delivered as an interactive group intervention but can also be administered individually and through remote technology. Important questions remain regarding its implementation in different rehabilitation settings, the influence of treatment format and intensity on outcomes, the maintenance of treatment-related changes, and individual variation in treatment response. GMT has not previously been evaluated in people receiving rehabilitation for long-term pain, despite the occurrence of executive, attentional, memory, and processing-speed difficulties in this population.
This is a non-randomized, open-label, multicenter clinical implementation and intervention study evaluating a Swedish version of GMT within routine rehabilitation services. The study comprises two distinct clinical cohorts: adults with acquired brain injury and executive dysfunction, and adults with long-term pain and associated executive difficulties or reduced working memory. Participants are recruited consecutively from participating rehabilitation services, and GMT is incorporated into the participant's individual rehabilitation plan.
The study evaluates GMT across three dimensions:
mode of administration, including in-person versus remote delivery and individual versus group-based treatment; treatment intensity, represented by five-, seven-, and nine-week formats; and diagnostic group, comprising acquired brain injury and long-term pain.
The study has three interrelated objectives. The first is to evaluate the implementation and clinical applicability of Swedish GMT across rehabilitation settings and delivery formats. The second is to examine treatment-related changes in cognitive functioning, everyday executive functioning, activity, and participation. The third is to investigate whether outcomes and individual improvement profiles differ according to diagnostic, demographic, and clinical characteristics, rehabilitation setting, treatment intensity, and mode of delivery.
The diagnostic cohorts are analyzed as distinct clinical populations rather than being combined into a single patient group. Analyses are conducted according to the objectives and predefined study groups of the respective substudies.
Within the acquired brain injury cohort, three context-adapted GMT formats are implemented at different rehabilitation centers. GMT-9 is delivered at a rehabilitation center in Östersund, GMT-7 is delivered at Garnis in Luleå, and GMT-5 is delivered within a high-intensity rehabilitation setting in Stockholm. GMT-7 and GMT-9 represent established treatment formats, whereas GMT-5 is an adapted format being evaluated within the study.
Assignment to treatment format is determined by the participating center, rehabilitation setting, and the participant's clinical rehabilitation needs rather than by random allocation. Comparisons between GMT-5, GMT-7, and GMT-9 therefore evaluate the relative outcomes of three context-adapted implementation models. As treatment intensity, center, and rehabilitation context are linked, these comparisons are not intended to isolate the effect of intervention duration alone.
Participants with long-term pain constitute a separate diagnostic cohort. This part of the study evaluates the feasibility and clinical outcomes of GMT among individuals receiving pain rehabilitation who also experience executive difficulties or reduced working memory.
Across the study, GMT may be delivered in groups or individually, either in person or remotely, according to clinical need and local feasibility. Group-based treatment may involve more than one clinician, whereas individually administered treatment, including remotely delivered treatment, is provided by a single clinician.
The study is open label. Participants and treating professionals are aware that GMT is being provided. Neuropsychological assessments are conducted by a psychologist other than the treating clinician; however, the assessor is aware that the participant is enrolled in the study. No participant, clinician, or outcome-assessor masking is therefore applied.
The evaluation is informed by the International Classification of Functioning, Disability and Health framework. Treatment-related changes are examined across the domains of body functions, activities, and participation.
At the level of body functions, the study addresses cognitive processes relevant to executive control, attention, working memory, and goal-directed behavior. At the activity level, the study examines the participant's ability to plan, organize, initiate, monitor, and complete everyday tasks. At the participation level, the study concerns functioning in broader life situations, including work, education, family life, social relationships, and community activities.
Assessments are conducted before the intervention, immediately after its completion, and at the follow-up points specified for the applicable substudy and outcome measure. The study examines both short-term treatment-related changes and the maintenance of outcomes over time. Where included in the applicable substudy, the contribution of booster sessions to continued strategy use and maintenance of treatment-related changes is also evaluated.
An additional objective is to examine individual improvement profiles rather than relying exclusively on average changes at group level. Response to cognitive rehabilitation may vary according to demographic and clinical characteristics, the nature and extent of cognitive difficulties, rehabilitation context, treatment format, and the participant's ability to learn, apply, and maintain compensatory strategies. Exploring this variation may support more individualized decisions regarding treatment format, intensity, and follow-up.
The multicenter design also allows GMT to be evaluated under different clinical and geographical conditions. Remote delivery may increase access to specialized rehabilitation when travel distances or other practical barriers limit in-person attendance. However, because cognitive difficulties may affect a participant's ability to use digital technology, remote delivery is evaluated as a clinical implementation format rather than assumed to be suitable for all participants.
Written informed consent is obtained from all participants before study inclusion and in connection with the eligibility assessment. At baseline, participants undergo neuropsychological assessment and complete measures of everyday executive functioning, psychological health, activity, participation, fatigue, and health-related quality of life, as applicable to the relevant cohort and substudy.
Demographic and health-related information is collected through participant interviews. Relevant diagnostic, injury-related, and clinical information is obtained from medical records and clinical history. The participant's involvement in the study is documented in the medical record.
Selected baseline measures are used for eligibility assessment, characterization of the study population, or planned predictor and covariate analyses rather than as intervention outcomes. Nonverbal reasoning ability is assessed with the Matrix Reasoning subtest of the Wechsler Adult Intelligence Scale-Fourth Edition. Baseline planning and execution are assessed using the Zoo Map Test from the Behavioural Assessment of the Dysexecutive Syndrome. The Rey 15-Item Test is used to support the interpretation of neuropsychological test performance. Resilient coping is assessed with the Brief Resilient Coping Scale and may be examined as a baseline predictor or covariate.
GMT is delivered by experienced neuropsychologists and occupational therapists with clinical expertise in cognitive rehabilitation and knowledge of the relevant patient populations.
Before participating in study-related treatment and data collection, clinicians complete standardized training in the theoretical basis, structure, objectives, and practical components of GMT. Training includes theoretical instruction, interactive workshops, joint review of treatment content and exercises, and discussion of clinical implementation. Clinicians are encouraged to gain practical experience delivering GMT before initiating study data collection.
Manual-based treatment materials and common assessment and scoring procedures are used across participating centers to support treatment fidelity and consistency in intervention delivery and outcome assessment. A shared communication forum is available throughout the study to address questions arising during treatment and implementation.
Study data are pseudonymized, and the code linking study identifiers to participant identities is stored separately from the research data. Study materials and data are handled in accordance with the approved study procedures and applicable data-protection requirements.
Recruitment began in 2022 and is ongoing. The intervention protocol and planned outcome assessments were approved by the ethics review authority before study initiation. An ethics amendment approved in 2026 added further measures and extended the data-collection period. The protocol, outcomes, and analyses relevant to the respective substudies are specified before completion of data collection and the corresponding outcome analyses.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 120 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria meeting either of the following clinical profiles:
1 a) Acquired brain injury (ABI) with an indicated need for rehabilitation and presenting with self-reported and/or test-verified executive dysfunction or working memory deficits.
1 b) Referred to the Pain Section at the Regional University Hospital (RUS) for standard pain rehabilitation and presenting with self-reported and/or test-verified executive dysfunction or working memory deficits.
2. Aged between 18 and 67 years. 3. Participating in team-based rehabilitation at one of the participating multicenter sites.
4. Provided written to participate in the study from the patient or a next of kin/legally authorized representative.
The intervention requires at least moderate illness insight, some awareness of how difficulties manifest in daily life, and adequate memory retention to learn and generalize strategies outside of session. Consequently, the following exclusion criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Goal Management Training (GMT) is a group-based intervention for executive dysfunction intended to promote cognitive control when behaviour is incompatible with stated goals. It comprises self-instruction strategies, self-monitoring exercises and homework assignments. Arm 1 comprises 10 hrs (2 hrs weekly, 5 weeks), led by a neuropsychologist and an occupational therapist specialized in brain injury rehabilitation. The GMT is administered within outpatient rehabilitation services.
Behavioral: Goal Management Training (GMT)
Goal Management Training (GMT) is a group-based intervention for executive dysfunction intended to promote cognitive control when behaviour is incompatible with stated goals. It comprises self-instruction strategies, self-monitoring exercises and homework assignments. Arm 1 comprises 14 hrs (2 hrs weekly, 7 weeks), led by a neuropsychologist and an occupational therapist specialized in brain injury rehabilitation. The GMT is administered within outpatient rehabilitation services.
Behavioral: Goal Management Training (GMT)
Goal Management Training (GMT) is a group-based intervention for executive dysfunction intended to promote cognitive control when behaviour is incompatible with stated goals. It comprises self-instruction strategies, self-monitoring exercises and homework assignments. Arm 1 comprises 18 hrs (2 hrs weekly, 9 weeks), led by a neuropsychologist and an occupational therapist specialized in brain injury rehabilitation. The GMT is administered within outpatient rehabilitation services.
Behavioral: Goal Management Training (GMT)
Goal Management Training (GMT; Levine et al., 2011) is an evidence-based, module-based metacognitive program designed to treat executive dysfunction and goal neglect by fostering deliberate, goal-directed behavior. The protocol utilizes a five-step, mindfulness-integrated cognitive algorithm-Stop, Define, List, Learn, Check-combined with interactive tasks and real-world homework to facilitate improved attention and task management.
Change following Goal Management Training in participant-reported everyday executive difficulties over the follow-up period measured with the Dysexecutive Questionnaire (DEX)
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.
Time frame: Change over time will be evaluated using assessments conducted at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up.
Change in Attainment of Individual Rehabilitation Goals with Goal Attainment Scale (GAS), Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in functional ability, adjustment, and participation with the Mayo-Portland Adaptability Inventory-4 (MPAI-4) following Goal Management Training.
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.
Time frame: Change over time will be evaluated using assessments conducted at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up.
Change following Goal Management Training in informant-reported everyday executive difficulties over the follow-up period measured with the Dysexecutive Questionnaire for informants (DEX)
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Observed Work Performance with Assessment of Work Performance (AWP) Following Goal Management Training
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
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Self-Rated Occupational Performance and satisfaction with performance Following with Canadian Occupational Perfomrance Measure (COPM) 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.
Time frame: Baseline and immediately after completion of Goal Management Training
Change in Executive Attention and Working Memory Measured With the Paced Auditory Serial Addition Test (PASAT) Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Inhibitory Control and Cognitive Flexibility Measured With the D-KEFS Color-Word Interference Test Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change from Baseline in Visual-Motor Sequencing and Set-Shifting (D-KEFS Trail Making Test)
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).
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Verbal Phonemic and Semantic Fluency and Cognitive Flexibility Measured With the D-KEFS Verbal Fluency Test Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Processing Speed and Attention including Performance Fatigability Measured With the WAIS-IV NI Coding Subtest From Baseline to Follow-Up
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).
Time frame: Baseline and and at 6 months and 12 months after completion of Goal Management Training
Change in Mental Fatigue Measured With the Multidimensional Fatigue Inventory (MFI-20)Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Self-Rated Mental Fatigue During Goal Management Training Sessions
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.
Time frame: Immediately before and after each Goal Management Training session throughout the intervention period of 5, 7, or 9 weeks
Change in Self-Rated Pain Discomfort During Goal Management Training Sessions in the Long-Term Pain Cohort
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.
Time frame: Immediately before and after each Goal Management Training session throughout the intervention period
Change in Depression and Anxiety Symptoms Measured With the Hospital Anxiety and Depression Scale Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Global Life Satisfaction Measured With the Life Satisfaction Questionnaire-11 Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Health-Related Quality of Life Measured With the EQ-5D-3L Health Utility Index Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Self-Rated Health Measured With the EQ Visual Analogue Scale Following Goal Management Training
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.
Time frame: Baseline, immediately after completion of Goal Management Training, 6 months after completion, and 12 months after completion
Change in Sense of Coherence (SOC-13) From Baseline to 12-Month Follow-Up
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.
Time frame: Baseline and 12 months after completion of Goal Management Training
Change in Self-Rated Mental Fatigue During Neuropsychological Assessment
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.
Time frame: Immediately before and after neuropsychological assessment at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up
Change in Self-Rated Pain Discomfort During Neuropsychological Assessment in the Chronic Pain Cohort
Pain-related discomfort is rated immediately before and immediately after each neuropsychological assessment 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 the within-assessment change from the pre-assessment rating to the post-assessment rating.
Time frame: Immediately before and after neuropsychological assessment at baseline, immediately after Goal Management Training, and at 6- and 12-month follow-up
Not enrolling at this site.
Plan to share: No — Individual participant data are not planned to be shared. The study includes sensitive clinical and neuropsychological data from relatively small clinical cohorts, which may limit the possibility of complete de-identification. Aggregate findings will be disseminated through scientific publications.
Started Mar 2022 (actual). Primary completion is estimated for Dec 2029, 93 months after the start.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 93 months is above that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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