The prevalence and meaning of fatigue in rheumatic disease.
F Wolfe, D J Hawley, K Wilson
https://pubmed.ncbi.nlm.nih.gov/8856621/Actively Recruiting
Led by Terry L. Wahls · Updated on 2026-08-10
400
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the effectiveness of an online health program aimed at improving diet and self-care among adults with various rheumatological conditions such as rheumatoid arthritis, Sjogrens syndrome, systemic lupus erythematosus, mixed connective tissue disease, psoriatic arthritis, as well as mood disorders including anxiety and moderate depression. The study also seeks to understand the challenges and supports in using this online wellness program to reduce fatigue and improve quality of life for these patients. Participants will be randomized into two groups one receiving immediate access and another with delayed access after 12 weeks to the Creating Health Online Course. The course includes audio and video materials covering diet plans like the modified Paleolithic elimination diet, nutrient-dense vegetarian, and Mediterranean diets, alongside modules on exercise, stress management, resilience, supplements, light therapy, detoxification, sleep, and other health strategies. The program is delivered entirely online through a secure platform and involves exercises and personal assessments designed to enhance learning and self-care. The study is conducted fully online with three virtual visits at 0, 3, and 6 months where participants complete questionnaires assessing fatigue, quality of life, dietary habits, mood, anxiety, sleep, loneliness, and cognitive function. Participants are encouraged to work with their healthcare providers to tailor the courses recommendations. Data is collected at baseline, 3 months, and 6 months to analyze the programs impact on health outcomes in these populations.
CONDITIONS
Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders
S
Study Coordinator
M
Mary Ehlinger, BS
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Terry L. Wahls
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Immediate Course | Delayed Course (Wait-list Control) |
|---|---|---|
| What it is | Participants begin a 12-week online audio/video health course immediately after enrolling, focusing on improving resilience, diet, exercise, stress reduction, and self-care routines. | Participants wait 12 weeks before starting the same online health course and serve as a wait-list control for the initial period. |
| Role in trial | Experimental intervention arm; participants receive the full course content starting at enrollment. | Comparator arm/control; participants wait 12 weeks before accessing the course materials. |
| Primary use | Intended to reduce fatigue and improve wellbeing for adults with rheumatological conditions and moderate mood disorders by providing digital behavioral health education. | Used as a control condition in the trial for initial 12 weeks, then as intervention for delayed group. Final intent matches immediate arm. |
| How it is given or performed | Access to an online course with multimedia education on resilience, dietary improvement, exercise, stress management, and self-care, delivered via internet-enabled devices over 12 weeks starting at enrollment. | Participants wait 12 weeks before accessing the same online course; the course is then delivered identically via internet-enabled devices. |
| Evidence status | Currently under randomized controlled investigation; no published results available for this specific intervention in this patient population. | Serves as control for initial 12 weeks, then receives the intervention. No effectiveness data for delayed group available yet. |
| Important limitations | This behavioral online intervention's effectiveness in fatigue and mental health is still being evaluated; participants must have digital access, sufficient English literacy, and internet-enabled devices. Adherence to digital programs can vary, and results may not generalize beyond trial conditions. No peer-reviewed outcome data for this intervention in this specific population are currently available. | Outcomes for the delayed group may be affected by events during the wait-list period. Like the immediate group, engagement depends on digital literacy and resources, and published effectiveness data are not yet established. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual consent and screening visit
Duration - 6 months
Participants receive immediate or delayed access to the Creating Health Online Course, which includes modules on diet, exercise, stress reduction, and self-care strategies.
Three virtual visits at months 0, 3, and 6
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
F Wolfe, D J Hawley, K Wilson
https://pubmed.ncbi.nlm.nih.gov/8856621/Cassidy Dean, Samantha Parks, Tyler J Titcomb...
https://pubmed.ncbi.nlm.nih.gov/36090239/Stephanie Nikolaus, Christina Bode, Erik Taal...
https://pubmed.ncbi.nlm.nih.gov/23335492/Sevinç Can Sandıkçı, Zeynep Özbalkan
https://pubmed.ncbi.nlm.nih.gov/27708942/Roald Omdal, Svein Ivar Mellgren, Wenche Koldingsnes...
https://pubmed.ncbi.nlm.nih.gov/11908560/Frederick W Miller
https://pubmed.ncbi.nlm.nih.gov/36446151/Terry L. Wahls
Lead Sponsor