Actively Recruiting
A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue - a Randomized Controlled Study
Led by Vastra Gotaland Region · Updated on 2025-11-21
96
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying mental fatigue in patients with Graves' disease, a common form of hyperthyroidism. Mental fatigue includes trouble focusing, feeling tired during mental tasks, memory problems, and mood changes, which often lower quality of life. This study aims to see if a special mental fatigue course can improve mental fatigue and overall mental ability, quality of life, and function compared to usual care. The study also looks at whether this course is cost-effective. Participants are randomly assigned to either a mental fatigue course plus usual care or usual care alone. The mental fatigue course involves six meetings of two hours each, held every two weeks over 12 weeks, with groups of 10 to 15 people. These sessions cover topics like understanding mental fatigue, managing emotions, balancing rest and activity, meditation, and mindfulness. Usual care includes follow-up visits and blood tests related to Graves' disease treatment. Participants will be assessed at the start and then at 3, 6, and 12 months after starting the study. Researchers will measure mental fatigue levels as the main outcome at 3 months, along with other mental health, quality of life, coping, stress, thyroid function, and work productivity outcomes over time. Safety and ongoing health will be monitored throughout the study, which lasts up to 12 months for each participant.
CONDITIONS
Brief Title
Course for Brain Fatigue After Graves' Disease Controlled Study
Who Can Participate
Eligibility Criteria
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 diagnosis
- Normal thyroid hormone levels for the past 6 months before inclusion
- Symptoms of mental fatigue related to Graves' disease
- Mental fatigue scale score of 10.5 points or higher
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
- Unable to follow the study protocol as assessed by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants undergo a Mental Fatigue course consisting of six 2-hour meetings every two weeks over 12 weeks focusing on understanding and managing mental fatigue, combined with usual health care follow-up. Some participants receive usual care only.
6 group meetings every two weeks over 12 weeks plus 1 to few follow-up visits with blood tests
Duration - Up to 12 months
Participants are followed up to assess changes in mental fatigue and other health outcomes after completing treatment.
Visits at 3, 6, and 12 months post-treatment
Trial Site Locations
Total: 1 location
1
Agneta Lindo
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
A
Agneta Lindo
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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