A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue -a Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 72
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Agneta Lindo
RECRUITING
Gothenburg
Contact Information
Primary
Agneta Lindo
agneta.lindo@vgregion.se
+4676-6185481
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2026-10-10
Participants
Target number of participants: 96
Treatments
Experimental: Intervention
Mental Fatigue course + Usual care in clinical care
Active_comparator: Control Group
Usual care in clinical care
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov