Course for Brain Fatigue After Graves' Disease Controlled Study

NCT ID: NCT06134219

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2027-05-10

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.

Conditions

Graves Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Mental Fatigue course + Usual care in clinical care

Group Type: EXPERIMENTAL

MF course

Intervention Type: OTHER

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 care

Intervention Type: OTHER

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.

Control Group

Usual care in clinical care

Group Type: ACTIVE_COMPARATOR

Usual health care

Intervention Type: OTHER

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.

Interventions

MF course

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).

Intervention Type: OTHER

Usual health care

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helena Filipsson Nyström

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Universitet sjukhus

Locations

Agneta Lindo

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Agneta Lindo

Role: CONTACT

agneta.lindo@vgregion.se

+4676-6185481

Facility Contacts

Agneta Lindo

Role: primary

agneta.lindo@vgregion.se

+4676-6185481

Other Identifiers

MF-Course

Identifier Type: -

Identifier Source: org_study_id