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Not recruiting

Observational Study

Sponsor:

Terry L. Wahls

Code:

NCT05057676

Conditions

Multiple Sclerosis

Clinically Isolated Syndrome

Fibromyalgia

Post Acute Sequelae of COVID-19

Cancer in Remission With Persisting Fatigue

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Immediate Autoimmune Intervention Mastery Course (AIM)

Immediate Question and Answer sessions. (AIM Q and A sessions)

Delayed Autoimmune Intervention Mastery Course (delayed AIM course)

Delayed AIM Question and Answer sessions

Study Details

Brief summary:

The goal of this project is to critically evaluate the effectiveness of using an online program to improve diet and self-care in patients with multiple sclerosis (MS), clinically isolated syndrome (CIS), fibromyalgia, post acute sequela of covid, and cancer in remission with persisting fatigue.

Conditions

Multiple Sclerosis

Clinically Isolated Syndrome

Fibromyalgia

Post Acute Sequelae of COVID-19

Cancer in Remission With Persisting Fatigue

Study ID

NCT05057676

Start date

Dec 1, 2021

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • self-reported multiple sclerosis
  • self-reported clinically isolated syndrome

OR self-reported post-acute sequelae of COVID (PASC), also known as long COVID, with a confirmed laboratory test of COVID-19 infection, persisting fatigue and neuropsychiatric symptoms for longer than 6 months after confirmation of COVID diagnosis,

OR self-reported diagnosis of fibromyalgia as documented by their treating specialist or primary care provider,

Exclusion Criteria:

\-

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Autoimmune Intervention Mastery Course (AIM) online course

This arm will begin the intervention immediately after randomization

other: Delayed Autoimmune Intervention Mastery Course

This is the control arm.

Interventions

Immediate Autoimmune Intervention Mastery Course (AIM)

Immediate access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care

Immediate Question and Answer sessions. (AIM Q and A sessions)

Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.

Delayed Autoimmune Intervention Mastery Course (delayed AIM course)

Delayed access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care

Delayed AIM Question and Answer sessions

Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.

Primary outcome measure

  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 3 months ]
  • Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH) [ Time Frame: baseline to 6months ]
  • Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 3 months ]
  • Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH) [ Time Frame: baseline to 6 months ]
  • Short form 36 (SF 36) [ Time Frame: baseline to 3 months ]
  • Short form 36 (SF 36) [ Time Frame: baseline to 6 months ]
  • The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS): [ Time Frame: baseline to 3 months ]
  • The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS): [ Time Frame: baseline to 6 months ]

Central Contacts and Locations

More Information

Sponsor

Terry L. Wahls

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • diet
  • self care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Terry L. Wahls on 2026-08-10.