Course for Brain Fatigue After Graves' Disease Controlled Study

Official title

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

Overview

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.

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.

Primary outcome measures

• Mental fatigue score [Time frame: Change from baseline examined at 3 months follow-up.]

Secondary outcome measures (12)

• Comprehensive psychopathological rating questionnaire (CPRS) [Time frame: Change from baseline examined at 3 months follow-up.]
• Comprehensive psychopathological rating questionnaire (CPRS) [Time frame: Change from baseline examined at 6 months follow-up.]
• Comprehensive psychopathological rating questionnaire (CPRS) [Time frame: Change from baseline examined at 12 months follow-up.]
• Coping Orientations to Problems Experienced (Brief cope) [Time frame: Change from baseline examined at 3 months follow-up.]
• Coping Orientations to Problems Experienced (Brief cope) [Time frame: Change from baseline examined at 6 months follow-up.]
• Coping Orientations to Problems Experienced (Brief cope) [Time frame: Change from baseline examined at 12 months follow-up.]
• General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 3 months follow-up.]
• General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 6 months follow-up.]
• General Self-Efficacy Scale (GSE) [Time frame: Change from baseline examined at 12 months follow-up.]
• Perceived Stress Scale (PSS-14) [Time frame: Change from baseline examined at 3 months follow-up.]
• Perceived Stress Scale (PSS-14) [Time frame: Change from baseline examined at 6 months follow-up.]
• Perceived Stress Scale (PSS-14) [Time frame: Change from baseline examined at 12 months follow-up.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Agneta Lindo — Gothenburg

Identifiers

NCT: NCT06134219 · MF-Course

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗