Graves DiseaseMF-CourseNCT06134219
Course for Brain Fatigue After Graves' Disease Controlled Study
A study testing MF course and Usual health care in people with Graves Disease, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and… Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- MF course and Usual health care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- 10 Oct 2023to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-72 years old
- 15-72 months since first Graves' diagnosis
- high free thyroxin and thyroid antibodies (TRAb) at diagnosis
- euthyroid the last 6 months normal thyroid hormone levels at inclusion
- symptoms on MF in connection to Graves diagnosis
- MF-scale ≥10.5 points
Who cannot join
- other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease)
- pregnancy
- lactation
- assessment that the patient cannot follow the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Agneta Lindo
Gothenburg, 413 45
Agneta Lindo, +4676-6185481, agneta.lindo@vgregion.se
Helena Filipsson Nyström
About this study
Official title: A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue -a Randomized Controlled Study
BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation.
AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention.
Read more
METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months.
CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units.
In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.
- Conditions
- Graves Disease
- Being tested
- MF course, Usual health care
- Keywords
- Mental fatigue
- Medical subject headings
- Graves Disease, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF courseOther
A course consisting of six 2-hour-meetings every two-weeks with 10-15 participants (12 weeks in total). The meetings have different themes related to MF, such as understanding, practices for a deeper understanding of emotions, balance in everyday life with rest and activity, meditation practice to give time for brain rest, and mindfulness).
Usual health careOther
The usual health care consists of one or few follow-up visits with blood tests at Sahlgrenska university hospital in Gothenburg or follow-up at the primary care after the end of treatment for Graves' treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mental Fatigue course + Usual care in clinical care Receives: Other: MF course; Other: Usual health care |
| Control Group | Active comparator | Usual care in clinical care Receives: Other: Usual health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 3 months follow-up.
Secondary outcomes (44)
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 3 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 6 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS). Scores are compared between the intervention and the control group. Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression. The Scores for anxiety is between 0-27 and for depression is between 0-27.
Measured: Change from baseline examined at 12 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each). The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Evaluated by the validated questionnaire Brief cope. The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).The overall mean is calculated with more than three being worse outcome. Coping strategies are compared between the intervention and the control group.
Measured: Change from baseline examined at 12 months follow-up.
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 6 months follow-up.
General Self-Efficacy Scale (GSE)
Evaluated by the validated questionnaire General Self-Efficacy. Scores are compared between the intervention and the control group. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Change from baseline examined at 12 months follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 3 months follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 6 months follow-up.
Perceived Stress Scale (PSS-14)
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14). Scores are compared between the intervention and the control group. The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
Measured: Change from baseline examined at 12 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 3 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. hyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 6 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39). Scores are compared between the intervention and the control group. hyPRO scales is scored as a summary score and linearly transformed to range 0- 100. Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
Measured: Change from baseline examined at 12 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 3 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 6 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL). Scores are compared between the intervention and the control group. The range of each score is from 0 to 100, higher scores indicating better health.
Measured: Change from baseline examined at 12 months follow-up.
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 3 months follow-up.
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 6 months follow-up.
EuroQol- health questionnaire (EQ-5D)
Evaluated by the validated questionnaire EuroQol- health (EQ-5D). Scores are compared between the intervention and the control group. Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state. The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1. This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
Measured: Change from baseline examined at 12 months follow-up.
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 3 months follow-up.
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 6 months follow-up.
Frenchay Activities Index (FAI)
Evaluated by the validated Frenchay Activities Index (FAI). Compare function and work ability between the intervention and the control group. Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active).
Measured: Change from baseline examined at 12 months follow-up.
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 3 months follow-up.
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI).
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 6 months follow-up.
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group.
Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents.
Measured: Change from baseline examined at 12 months follow-up.
Days of sick-leave and cost related to health care and medication
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up.
Days of sick-leave and cost related to health care and medication
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up.
Days of sick-leave and cost related to health care and medication
Evaluated sick leave days between the intervention and the control group.
Measured: Change from baseline examined at 12 months follow-up.
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up.
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up.
Levels of thyroid autoantibodies
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 12 months follow-up.
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 3 months follow-up.
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 6 months follow-up.
Levels of thyroid hormones
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
Measured: Change from baseline examined at 12 months follow-up.
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 3 months follow-up.
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 6 months follow-up.
Clinical Activity Score (CAS)
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-10 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 12 months follow-up.
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 3 months follow-up.
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 6 months follow-up.
Severity score
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group. Scores can be between 0-29 and higher scores mean more eye symptoms.
Measured: Change from baseline examined at 12 months follow-up.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores can be between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 6 months follow-up.
Mental fatigue score
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores can be between 0-42 and higher scores mean more brain fatigue.
Measured: Change from baseline examined at 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Oct 2023
- Primary completion10 Jul 2026 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Helena Filipsson Nyström, Principal investigator, Sahlgrenska Universitet sjukhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134219
- Sponsor's protocol ID
- MF-Course
- Acronym
- MF-Course
- Status last verified
- Oct 2025
- First submitted
- 10 Nov 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue -a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06134219
- Acronym / sponsor ID
- MF-Course / MF-Course
- Conditions
- Graves Disease
- Keywords
- Mental fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation.
AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention.
METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months.
CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units.
In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MF course, Other: Usual health careMental Fatigue course + Usual care in clinical care |
| Control Group | Active comparator | Other: Usual health careUsual care in clinical care |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-72 years old
- 15-72 months since first Graves' diagnosis
- high free thyroxin and thyroid antibodies (TRAb) at diagnosis
- euthyroid the last 6 months normal thyroid hormone levels at inclusion
- symptoms on MF in connection to Graves diagnosis
Key exclusion criteria (4 listed)
- other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease)
- pregnancy
- lactation
- assessment that the patient cannot follow the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF courseA course consisting of six 2-hour-meetings every two-weeks with 10-15 participants (12 weeks in total). The meetings have different themes related to MF, such as understanding, practices for a deeper understanding of emotions, balance in everyday life with rest and activity, meditation practice to give time for brain rest, and mindfulness). | Other | Intervention |
| Usual health careThe usual health care consists of one or few follow-up visits with blood tests at Sahlgrenska university hospital in Gothenburg or follow-up at the primary care after the end of treatment for Graves' treatment. | Other | Control Group, Intervention |
Primary outcome
Mental fatigue score
Time frame: Change from baseline examined at 3 months follow-up.
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
44 secondary outcomes
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 3 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 6 months follow-up.
Comprehensive psychopathological rating questionnaire (CPRS)
Time frame: Change from baseline examined at 12 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 3 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 6 months follow-up.
Coping Orientations to Problems Experienced (Brief cope)
Time frame: Change from baseline examined at 12 months follow-up.
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 3 months follow-up.
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 6 months follow-up.
General Self-Efficacy Scale (GSE)
Time frame: Change from baseline examined at 12 months follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 3 months follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 6 months follow-up.
Perceived Stress Scale (PSS-14)
Time frame: Change from baseline examined at 12 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 3 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 6 months follow-up.
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time frame: Change from baseline examined at 12 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 3 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 6 months follow-up.
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time frame: Change from baseline examined at 12 months follow-up.
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 3 months follow-up.
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 6 months follow-up.
EuroQol- health questionnaire (EQ-5D)
Time frame: Change from baseline examined at 12 months follow-up.
Frenchay Activities Index (FAI)
Time frame: Change from baseline examined at 3 months follow-up.
Frenchay Activities Index (FAI)
Time frame: Change from baseline examined at 6 months follow-up.
Frenchay Activities Index (FAI)
Time frame: Change from baseline examined at 12 months follow-up.
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Time frame: Change from baseline examined at 3 months follow-up.
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI).
Time frame: Change from baseline examined at 6 months follow-up.
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Time frame: Change from baseline examined at 12 months follow-up.
Days of sick-leave and cost related to health care and medication
Time frame: Change from baseline examined at 3 months follow-up.
Days of sick-leave and cost related to health care and medication
Time frame: Change from baseline examined at 6 months follow-up.
Days of sick-leave and cost related to health care and medication
Time frame: Change from baseline examined at 12 months follow-up.
Levels of thyroid autoantibodies
Time frame: Change from baseline examined at 3 months follow-up.
Levels of thyroid autoantibodies
Time frame: Change from baseline examined at 6 months follow-up.
Levels of thyroid autoantibodies
Time frame: Change from baseline examined at 12 months follow-up.
Levels of thyroid hormones
Time frame: Change from baseline examined at 3 months follow-up.
Levels of thyroid hormones
Time frame: Change from baseline examined at 6 months follow-up.
Levels of thyroid hormones
Time frame: Change from baseline examined at 12 months follow-up.
Clinical Activity Score (CAS)
Time frame: Change from baseline examined at 3 months follow-up.
Clinical Activity Score (CAS)
Time frame: Change from baseline examined at 6 months follow-up.
Clinical Activity Score (CAS)
Time frame: Change from baseline examined at 12 months follow-up.
Severity score
Time frame: Change from baseline examined at 3 months follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Graves Disease
RecruitingPhase 2
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Graves' Disease
RecruitingPhase 2
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
Not yet recruitingPhase 2/3
An Open-Label Study to Determine if BHV-1300 is Safe in Adults With Graves' Disease
Graves' Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
Graves Disease
RecruitingObservational study
Early Risk Stratification of Thyroid Eye Disease in Newly Diagnosed Graves' Disease
Graves' Orbitopathy, Thyroid Eye Disease, TED
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Filipsson Nyström principal investigator
Sahlgrenska Universitet sjukhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MF course and Usual health care in people with Graves Disease, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agneta Lindo (+4676-6185481, agneta.lindo@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental fatigue score (time frame: Change from baseline examined at 3 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.