Course for Brain Fatigue After Graves' Disease Controlled Study

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

Interventions

OTHER

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).

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.

Sponsors & Collaborators

• Vastra Gotaland Region

  lead OTHER_GOV

Principal Investigators

• Helena Filipsson Nyström · Sahlgrenska Universitet sjukhus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

72 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-10

Primary Completion

2026-07-10

Completion

2027-05-10

Countries

• Sweden

Study Locations