Clinical trial NCT06134219: Course for Brain Fatigue After Graves' Disease Controlled Study
Official title: A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue -a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graves Disease
Keywords: Mental fatigue
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Mental fatigue score
timeFrame: Change from baseline examined at 3 months follow-up.
Secondary outcomes:
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Comprehensive psychopathological rating questionnaire (CPRS)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Coping Orientations to Problems Experienced (Brief cope)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: General Self-Efficacy Scale (GSE)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Perceived Stress Scale (PSS-14)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
timeFrame: Change from baseline examined at 12 months follow-up.
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: EuroQol- health questionnaire (EQ-5D)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Frenchay Activities Index (FAI)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI).
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Days of sick-leave and cost related to health care and medication
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Days of sick-leave and cost related to health care and medication
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Days of sick-leave and cost related to health care and medication
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Levels of thyroid autoantibodies
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Levels of thyroid hormones
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Clinical Activity Score (CAS)
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Severity score
timeFrame: Change from baseline examined at 3 months follow-up.
measure: Severity score
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Severity score
timeFrame: Change from baseline examined at 12 months follow-up.
measure: Mental fatigue score
timeFrame: Change from baseline examined at 6 months follow-up.
measure: Mental fatigue score
timeFrame: Change from baseline examined at 12 months follow-up.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Agneta Lindo
Study officials:
affiliation: Sahlgrenska Universitet sjukhus
name: Helena Filipsson Nyström
role: PRINCIPAL_INVESTIGATOR
References: