Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- Terry L. Wahls
- Study ID
- NCT07180537
- Status
- Recruiting
Conditions
- Anxiety Disorders
- Depressive Disorders
- Mixed Connective Tissue Disease
- Moderate Anxiety
- Moderate Depression
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Sjogren's Syndrome
- Systemic Lupus Erythematosus
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Creating Health Online Course — BEHAVIORALImmediate access to an online audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care
- Delayed access to Creating Health Online Course — BEHAVIORALDelayed access (12-week delay) to an online audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care
Study Details
The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
Key Dates
- First listed
- Sep 18, 2025
- Start date
- Dec 1, 2025
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Immediate Intervention: Creating Health Online courseThis arm will begin the intervention immediately after randomization
- Other: Delayed Intervention: Creating Health Online courseThis is the control arm.
Primary Outcome Measure
Modified Fatigue Impact Scale (MFIS) [ Time Frame: Day 0 to Month 3 ]
Central Contacts
- Study Coordinator319 384 5002
- Mary Ehlinger, BS319 384 5002
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Univeristy of Iowa | Iowa City | Iowa | 52246 | Terry Wahls, MD (PRINCIPAL_INVESTIGATOR) Linda Snetselaar, PhD, RD (SUB_INVESTIGATOR) |
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