Course for Brain Fatigue After Graves' Disease Controlled Study

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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).
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Agneta Lindo — Gothenburg

Идентификаторы

NCT: NCT06134219 · MF-Course

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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