Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders

NCT ID
NCT07180537
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Terry L. Wahls
Conditions
Anxiety Disorders, Depressive Disorders, Mixed Connective Tissue Disease, Moderate Anxiety, Moderate Depression, Psoriatic Arthritis, Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions and Mood Disorders

Enrollment: 400 participants (Estimated).

What is being studied

  • Behavioral: Creating Health Online Course
  • Behavioral: Delayed access to Creating Health Online Course

Who may be eligible

Ages
18 Years to 100 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion criteria: 1. A diagnosis of one of the following: Rheumatoid Arthritis (RA), Sjogren's Syndrome, Systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), or Psoriatic Arthritis (PsA), as documented by their treating specialist or primary care provider, as reported by the participant. 2. Must be age 18 and older, at time of consent. 3. Must be fluent in both speaking and reading English. \*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call. 4. Must have access to high-speed internet with devices capable of audio/video streaming. 5. Must be willing to participate in an online health course designed to improve dietary intake and self-care routines to help improve cellular function and health, and complete online surveys over the course of a 6-month period. 6. Individuals must pass the Short Portable Mental Status Questionnaire with scores for normal mental functioning (up to 2 errors). Cognitive impairment as measured by the SPMS Questionnaire could interfere with the completion of the online course. SCORING\* 0-2 errors: normal mental functioning 3-4 errors: mild cognitive impairment 5-7 errors: moderate cognitive impairment 8-10 errors: severe cognitive impairment \*Allow one more error for a subject with only a grade school education. Allow one less error for a subject with education beyond high school. Source: Pfeiffer, E. (1975). A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. Journal of American Geriatrics Society. 23, 433-41. Exclusion criteria: 1. Inability to provide informed consent, including participation in a consent call conducted via Zoom with the study team during business hours (8:00 a.m. to 5:00 p.m. Central Time (Chicago)). 2. Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded. 3. Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance. 4. Any diagnosis or condition that is contraindicated from starting a gentle exercise program (ex. poorly controlled diseases of the heart, kidney, or liver in the prior 12 months, or severe psychiatric disease, e.g., schizophrenia, making adherence to study procedures difficult.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Iowa, United States: 1

Sample of listed locations

  • Univeristy of Iowa — Iowa City, Iowa, 52246, United States — Recruiting

Study details

Start date
December 1, 2025
Primary completion date
December 31, 2027
Completion date
December 31, 2027
First posted
September 18, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07180537
Registry last updated
August 10, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07180537 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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