Rheumatoid ArthritisNCT07180537
Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders
A study testing Creating Health Online Course and Delayed access to Creating Health Online Course in people with Rheumatoid Arthritis and Sjogren's Syndrome, run by Terry L. Wahls at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus
- What is being tested?
- Creating Health Online Course and Delayed access to Creating Health Online Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Must be age 18 and older, at time of consent.
- 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.
- Must have access to high-speed internet with devices capable of audio/video streaming.
- 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.
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- 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.
Who cannot join
- 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)).
- Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.
- Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Univeristy of Iowa
Iowa City, Iowa, 52246
Mary Ehlinger, BS, 319-384-5002, CH-studies@uiowa.edu
Whitney Schley, BA, (319) 356-8555, whitney-schley@uiowa.edu
About this study
Official title: Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions and Mood Disorders
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.
Read the detailed description
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, we 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.
Once the eligibility criteria are established and consent is obtained, investigators will invite study participants randomized to the intervention arm to the online course via email. Participants will be required to create a password to access the course. The online course and supplementary resources will be hosted on a secure website through the UIowa Canvas Classroom platform. Participants will progress through the online health course modules similarly to a non-graded online course. Within the course, there are exercises and personal assessments designed to enhance the participants' experience and success.
The course will cover various topics, including modules on developing an inner game plan, a food intervention plan, a physical intervention plan, and an increased resilience plan. The fourth module will propose various strategies to improve health beyond diet and exercise, such as the use of supplements, light therapy, detoxification, improved sleep, stress reduction, and other strategies to enhance bodily resilience.
Participants are encouraged to communicate and collaborate with their healthcare teams to personalize their treatment and determine whether the strategies suggested in the course are appropriate for their individual healthcare needs. This study aims to provide dietary education to a broader sample size than previously studied, including patients with limited resources such as financial constraints and geographic barriers that restrict access to registered dietitians experienced in dietary instruction for various rheumatological conditions. There is a growing interest in delivering education and support through an online platform to improve diet quality and self-care practices for autoimmune patients.
This study will utilize a randomized single-blind waitlist control design to evaluate the impact of the online course, which includes materials covering a modified Paleolithic elimination (MPE) diet, nutrient-dense vegetarian diets, Mediterranean diets, stress reduction techniques, and exercise strategies designed for autoimmune patients. Data will be collected in the short term (after 3 months) and long term (at the end of 6 months) to analyze the effects of the online wellness program on quality of life (QoL) and related outcomes among individuals with RA, SS, SLE, MCTD, PsA, anxiety disorders, depressive disorders, and moderate depression. .
Investigators will request that study participants complete their baseline assessments within approximately 7 to 14 days following consent. Participants will receive an individual link to their baseline assessments via REDCap. Patients will be randomized into different study arms based on their baseline fatigue severity scores.
The proposed study will be conducted entirely online. The schedule will include three virtual visits at three-month intervals (months 0, 3, and 6). Online questionnaires will be distributed via REDCap to assess fatigue, quality of life, and dietary information according to the study schedule (months 0, 3, and 6).
- Conditions
- Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Psoriatic Arthritis, Anxiety Disorders
- Being tested
- Creating Health Online Course, Delayed access to Creating Health Online Course
- Keywords
- diet, self-care, internet course, anxiety, depression, Sjogren's, rheumatoid arthritis, lupus, fatigue, arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Mixed Connective Tissue Disease, Arthritis, Psoriatic, Anxiety Disorders, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creating Health Online CourseBehavioural
Also called Online wellness course
Immediate 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 CourseBehavioural
Also called Online wellness course
Delayed 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 group | Role | What they receive |
|---|---|---|
| Immediate Intervention: Creating Health Online course | Experimental | This arm will begin the intervention immediately after randomization Receives: Behavioral: Creating Health Online Course |
| Delayed Intervention: Creating Health Online course | Other | This is the control arm. Receives: Behavioral: Delayed access to Creating Health Online Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: Day 0 to Month 3
Modified Fatigue Impact Scale (MFIS)
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Measured: Day 0 to Month 6
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Measured: Day 0 to Month 3
Fatigue Severity Scale (FFS)
Change in FSS survey questions, scores range from 1-63, lower score is better.
Measured: Day 0 to Month 6
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Measured: Day 0 to Month 3
Short form 36 (SF 36)
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Measured: Day 0 to Month 6
Rapid 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Measured: Day 0 to Month 3
Rapid 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Measured: Day 0 to Month 6
Secondary outcomes (17)
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Measured: Baseline
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Measured: Month 3
Mediterranean and Paleo Diet Screener
Mediterranean and Paleo Diet Screener questions, scores range 0-14, higher is better
Measured: Month 6
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Measured: Day 0 to Month 3
Hospital Anxiety and Depression Scale (HADS)
Change in HADS survey questions, scores range from 0-42, lower score is better.
Measured: Day 0 to Month 6
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Change in MDHAQ survey questions, scores range from 0 to 40, lower is better
Measured: Day 3 to Month 3
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Change in MDHAQ survey questions, scores range from 0 to 40, lower is better
Measured: Day 3 to Month 6
Patient Health Questionnaire -8
Questions about mood, scores range from 0 to 32, lower is better
Measured: Day 0 to Month 3
Patient Health Questionnaire -8
Questions about mood, scores range from 0 to 32, lower is better
Measured: Day 0 to Month 6
General Anxiety Disorder -7
Questions about anxiety, scores range from 0 to 28, lower is better
Measured: Day 0 to month 3
General Anxiety Disorder -7
Questions about anxiety, scores range from 0 to 28, lower is better
Measured: Day 0 to month 6
Perceived Deficits Questionnaire
Questions about thinking functions, scores range from 0 to 80, lower is better
Measured: Day 0 to month 3
Perceived Deficits Questionnaire
Questions about thinking functions, scores range from 0 to 80, lower is better
Measured: Day 0 to month 6
Single sleep questionnaire
Question about sleep quality, score ranges from 0 to 10, higher is better
Measured: Day 0 to month 3
Single sleep questionnaire
Question about sleep quality, score ranges from 0 to 10, higher is better
Measured: Day 0 to month 6
UCLA loneliness scale
Question about loneliness, scores range from 20 to 80, lower is better
Measured: Day 0 to month 3
UCLA loneliness scale
Question about loneliness, scores range from 20 to 80, lower is better
Measured: Day 0 to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- waitlist control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terry L. Wahls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terry L. Wahls, University of Iowa
- Investigators
- Terry L Wahls, MD, Other, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180537
- Sponsor's protocol ID
- 202503591
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sandikci SC, Ozbalkan Z. Fatigue in rheumatic diseases. Eur J Rheumatol. 2015 Sep;2(3):109-113. doi: 10.5152/eurjrheum.2015.0029. Epub 2015 Sep 1.
PubMed 27708942Wolfe F, Hawley DJ, Wilson K. The prevalence and meaning of fatigue in rheumatic disease. J Rheumatol. 1996 Aug;23(8):1407-17.
PubMed 8856621Nikolaus S, Bode C, Taal E, van de Laar MA. Fatigue and factors related to fatigue in rheumatoid arthritis: a systematic review. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1128-46. doi: 10.1002/acr.21949.
PubMed 23335492Omdal R, Mellgren SI, Koldingsnes W, Jacobsen EA, Husby G. Fatigue in patients with systemic lupus erythematosus: lack of associations to serum cytokines, antiphospholipid antibodies, or other disease characteristics. J Rheumatol. 2002 Mar;29(3):482-6.
PubMed 11908560Miller FW. The increasing prevalence of autoimmunity and autoimmune diseases: an urgent call to action for improved understanding, diagnosis, treatment, and prevention. Curr Opin Immunol. 2023 Feb;80:102266. doi: 10.1016/j.coi.2022.102266. Epub 2022 Nov 26.
PubMed 36446151Dean C, Parks S, Titcomb TJ, Arthofer A, Meirick P, Grogan N, Ehlinger MA, Bisht B, Fox SS, Daack-Hirsch S, Snetselaar LG, Wahls TL. Facilitators of and Barriers to Adherence to Dietary Interventions Perceived by Women With Multiple Sclerosis and Their Support Persons. Int J MS Care. 2022 Sep-Oct;24(5):235-241. doi: 10.7224/1537-2073.2021-051. Epub 2022 May 26.
PubMed 36090239
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions and Mood Disorders
- ClinicalTrials.gov ID
- NCT07180537
- Acronym / sponsor ID
- 202503591
- Conditions
- Rheumatoid Arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Mixed Connective Tissue Disease, Psoriatic Arthritis, Anxiety Disorders
- Keywords
- diet, self-care, internet course, anxiety, depression, Sjogren's, rheumatoid arthritis, lupus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Terry L. WahlsUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, we 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.
Once the eligibility criteria are established and consent is obtained, investigators will invite study participants randomized to the intervention arm to the online course via email. Participants will be required to create a password to access the course. The online course and supplementary resources will be hosted on a secure website through the UIowa Canvas Classroom platform. Participants will progress through the online health course modules similarly to a non-graded online course. Within the course, there are exercises and personal assessments designed to enhance the participants' experience and success.
The course will cover various topics, including modules on developing an inner game plan, a food intervention plan, a physical intervention plan, and an increased resilience plan. The fourth module will propose various strategies to improve health beyond diet and exercise, such as the use of supplements, light therapy, detoxification, improved sleep, stress reduction, and other strategies to enhance bodily resilience.
Participants are encouraged to communicate and collaborate with their healthcare teams to personalize their treatment and determine whether the strategies suggested in the course are appropriate for their individual healthcare needs. This study aims to provide dietary education to a broader sample size than previously studied, including patients with limited resources such as financial constraints and geographic barriers that restrict access to registered dietitians experienced in dietary instruction for various rheumatological conditions. There is a growing interest in delivering education and support through an online platform to improve diet quality and self-care practices for autoimmune patients.
This study will utilize a randomized single-blind waitlist control design to evaluate the impact of the online course, which includes materials covering a modified Paleolithic elimination (MPE) diet, nutrient-dense vegetarian diets, Mediterranean diets, stress reduction techniques, and exercise strategies designed for autoimmune patients. Data will be collected in the short term (after 3 months) and long term (at the end of 6 months) to analyze the effects of the online wellness program on quality of life (QoL) and related outcomes among individuals with RA, SS, SLE, MCTD, PsA, anxiety disorders, depressive disorders, and moderate depression. .
Investigators will request that study participants complete their baseline assessments within approximately 7 to 14 days following consent. Participants will receive an individual link to their baseline assessments via REDCap. Patients will be randomized into different study arms based on their baseline fatigue severity scores.
The proposed study will be conducted entirely online. The schedule will include three virtual visits at three-month intervals (months 0, 3, and 6). Online questionnaires will be distributed via REDCap to assess fatigue, quality of life, and dietary information according to the study schedule (months 0, 3, and 6).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- waitlist control
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention: Creating Health Online course | Experimental | Behavioral: Creating Health Online CourseThis arm will begin the intervention immediately after randomization |
| Delayed Intervention: Creating Health Online course | Other | Behavioral: Delayed access to Creating Health Online CourseThis is the control arm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Must be age 18 and older, at time of consent.
- 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.
- Must have access to high-speed internet with devices capable of audio/video streaming.
Key exclusion criteria (4 listed)
- 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)).
- Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.
- Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creating Health Online CourseAlso: Online wellness courseImmediate 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 | Behavioural | Immediate Intervention: Creating Health Online course |
| Delayed access to Creating Health Online CourseAlso: Online wellness courseDelayed 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 | Behavioural | Delayed Intervention: Creating Health Online course |
Primary outcome
Modified Fatigue Impact Scale (MFIS)
Time frame: Day 0 to Month 3
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Modified Fatigue Impact Scale (MFIS)
Time frame: Day 0 to Month 6
Change in MFIS survey questions, scores range from 0-84, lower score is better.
Fatigue Severity Scale (FFS)
Time frame: Day 0 to Month 3
Change in FSS survey questions, scores range from 1-63, lower score is better.
Fatigue Severity Scale (FFS)
Time frame: Day 0 to Month 6
Change in FSS survey questions, scores range from 1-63, lower score is better.
Short form 36 (SF 36)
Time frame: Day 0 to Month 3
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Short form 36 (SF 36)
Time frame: Day 0 to Month 6
Change in (SF 36) survey questions mean scores, range 0-100, higher number is better
Rapid 3
Time frame: Day 0 to Month 3
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
Rapid 3
Time frame: Day 0 to Month 6
Change in Rapid 3 survey questions mean scores, range 0-30, lower number is better
17 secondary outcomes
Mediterranean and Paleo Diet Screener
Time frame: Baseline
Mediterranean and Paleo Diet Screener
Time frame: Month 3
Mediterranean and Paleo Diet Screener
Time frame: Month 6
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 0 to Month 3
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 0 to Month 6
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Time frame: Day 3 to Month 3
Multi-Dimensional Health Assessment Questionnaire (MDHAQ)
Time frame: Day 3 to Month 6
Patient Health Questionnaire -8
Time frame: Day 0 to Month 3
Patient Health Questionnaire -8
Time frame: Day 0 to Month 6
General Anxiety Disorder -7
Time frame: Day 0 to month 3
General Anxiety Disorder -7
Time frame: Day 0 to month 6
Perceived Deficits Questionnaire
Time frame: Day 0 to month 3
Perceived Deficits Questionnaire
Time frame: Day 0 to month 6
Single sleep questionnaire
Time frame: Day 0 to month 3
Single sleep questionnaire
Time frame: Day 0 to month 6
UCLA loneliness scale
Time frame: Day 0 to month 3
UCLA loneliness scale
Time frame: Day 0 to month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 27708942Sandikci SC, Ozbalkan Z. Fatigue in rheumatic diseases. Eur J Rheumatol. 2015 Sep;2(3):109-113. doi: 10.5152/eurjrheum.2015.0029. Epub 2015 Sep 1.
- Background: PubMed 8856621Wolfe F, Hawley DJ, Wilson K. The prevalence and meaning of fatigue in rheumatic disease. J Rheumatol. 1996 Aug;23(8):1407-17.
- Background: PubMed 23335492Nikolaus S, Bode C, Taal E, van de Laar MA. Fatigue and factors related to fatigue in rheumatoid arthritis: a systematic review. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1128-46. doi: 10.1002/acr.21949.
- Background: PubMed 11908560Omdal R, Mellgren SI, Koldingsnes W, Jacobsen EA, Husby G. Fatigue in patients with systemic lupus erythematosus: lack of associations to serum cytokines, antiphospholipid antibodies, or other disease characteristics. J Rheumatol. 2002 Mar;29(3):482-6.
- Background: PubMed 36446151Miller FW. The increasing prevalence of autoimmunity and autoimmune diseases: an urgent call to action for improved understanding, diagnosis, treatment, and prevention. Curr Opin Immunol. 2023 Feb;80:102266. doi: 10.1016/j.coi.2022.102266. Epub 2022 Nov 26.
- Background: PubMed 36090239Dean C, Parks S, Titcomb TJ, Arthofer A, Meirick P, Grogan N, Ehlinger MA, Bisht B, Fox SS, Daack-Hirsch S, Snetselaar LG, Wahls TL. Facilitators of and Barriers to Adherence to Dietary Interventions Perceived by Women With Multiple Sclerosis and Their Support Persons. Int J MS Care. 2022 Sep-Oct;24(5):235-241. doi: 10.7224/1537-2073.2021-051. Epub 2022 May 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terry L Wahls, MD, Other principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creating Health Online Course and Delayed access to Creating Health Online Course in people with Rheumatoid Arthritis and Sjogren's Syndrome, run by Terry L. Wahls at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (319 384 5002, ch-studies@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Impact Scale (MFIS) (time frame: Day 0 to Month 3). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180537, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.