Actively Recruiting

Phase Not Applicable
Age: 18Years - 72Years
All Genders
NCT06134219

Course for Brain Fatigue After Graves' Disease Controlled Study

Led by Vastra Gotaland Region · Updated on 2025-11-21

96

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Course for Brain Fatigue After Graves' Disease Controlled Study

Who Can Participate

Age: 18Years - 72Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 72 years
  • Diagnosis of Graves' disease made 15 to 72 months ago
  • High free thyroxin and thyroid antibodies (TRAb) at time of diagnosis
  • Normal thyroid hormone levels for the last 6 months
  • Symptoms of mental fatigue related to Graves' disease
  • Mental fatigue scale score of 10.5 points or higher
Not Eligible

You will not qualify if you...

  • Presence of other diseases or conditions that may cause mental fatigue, such as active inflammatory or neurological diseases
  • Pregnancy
  • Breastfeeding
  • Inability to follow the study protocol as assessed by the researchers

AI-Screening

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Trial Site Locations

Total: 1 location

1

Agneta Lindo

Gothenburg, Sweden, 413 45

Actively Recruiting

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Research Team

A

Agneta Lindo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Course for Brain Fatigue After Graves' Disease Controlled Study | DecenTrialz