Course for Brain Fatigue After Graves' Disease Controlled Study

NCT06134219 | Recruiting

• 1 other identifier: MF-Course
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Mental fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline examined at 3 months follow-up.

Secondary Outcomes (44)

• Comprehensive psychopathological rating questionnaire (CPRS)

  Change from baseline examined at 3 months follow-up.

• Comprehensive psychopathological rating questionnaire (CPRS)

  Change from baseline examined at 6 months follow-up.

• Comprehensive psychopathological rating questionnaire (CPRS)

  Change from baseline examined at 12 months follow-up.

• Coping Orientations to Problems Experienced (Brief cope)

  Change from baseline examined at 3 months follow-up.

• Coping Orientations to Problems Experienced (Brief cope)

  Change from baseline examined at 6 months follow-up.

Study Arms (2)

Intervention

EXPERIMENTAL

Mental Fatigue course + Usual care in clinical care

Other: MF course; Other: Usual health care

Control Group

ACTIVE COMPARATOR

Usual care in clinical care

Other: Usual health care

Interventions

MF course 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).

Intervention

Usual health care 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; Intervention

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• months since first Graves' diagnosis
• high free thyroxin and thyroid antibodies (TRAb) at diagnosis
• symptoms on MF in connection to Graves diagnosis
• MF-scale ≥10.5 points

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Agneta Lindo

Gothenburg, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Graves Disease; Mental Fatigue

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Helena Filipsson Nyström

  Sahlgrenska Universitet sjukhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agneta Lindo

CONTACT

+4676-6185481; agneta.lindo@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): May 10, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

SE (1)