Autoimmune Intervention Mastery Course Study

BEHAVIORAL

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

BEHAVIORAL

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.

BEHAVIORAL

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

BEHAVIORAL

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.

Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

Time frame: baseline to 3 months

Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)

Time frame: baseline to 6months

Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better.

Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

Time frame: baseline to 3 months

Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)

Time frame: baseline to 6 months

Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better.

Short form 36 (SF 36)

Time frame: baseline to 3 months

Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.

Short form 36 (SF 36)

Time frame: baseline to 6 months

Change in (SF 36) survey questions mean scores, range 0-100, higher number is better.

The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):

Time frame: baseline to 3 months

FACIT-FS is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, which can be completed in less than 5 minutes.10 Each question provides 5 ordinal response options ("not at all," "a little bit," "somewhat," "quite a bit," and "very much"). Each item contributes equally (item score range=0-4) to a total score that ranges from 0 to 52, where higher scores represent less fatigue.

The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS):

Time frame: baseline to 6 months

FACIT-FS is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, which can be completed in less than 5 minutes.10 Each question provides 5 ordinal response options ("not at all," "a little bit," "somewhat," "quite a bit," and "very much"). Each item contributes equally (item score range=0-4) to a total score that ranges from 0 to 52, where higher scores represent less fatigue.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.