Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Gabriela Markovic, PhD
CONTACT
Marika Möller, associate professor
CONTACT
Lead
Karolinska Institutet
With
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.
Age
18–67
Sex
ALL
Healthy volunteers
Not accepted
