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Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

Factorial Optimization Randomized Controlled Trial to Test The Effects of Cognitive Behavioral Therapy Components For Multiple Sclerosis Fatigue

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A random sample of two participants from each trial condition with at least one component will also complete qualitative interviews at post-intervention."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether relaxation training, planning activities, and learning ways to change thinking patterns help reduce fatigue and improve daily life. It is for adults with multiple sclerosis (MS) who have had fatigue, or strong tiredness, for at least 3 months.

This randomized controlled factorial trial will examine whether and how relaxation training, behavioral activation, and cognitive therapy improve fatigue and functioning in fatigued adults living with multiple sclerosis.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of any type of MS.
  • Score 4 or higher on the Fatigue Severity Scale, a survey about tiredness.
  • Speak and read English fluently.
  • Be age 18 or older.
  • Be able to follow study steps and fill out surveys about yourself.
  • Agree to have audio recordings of sessions so researchers can check that treatment is given as planned.
  • Have had fatigue for at least 3 months.

Who can't join

  • Had an MS relapse, or flare-up, in the past 30 days. You may qualify after 30 days.
  • Changed medicines that treat the course of MS in the past 3 months. You may qualify after 3 months.
  • Currently have thoughts of suicide with a plan or intent to act, based on screening and further assessment. Thoughts without a plan or intent do not rule you out.
  • Currently receive talk therapy for fatigue.
  • Are in another study that could affect fatigue, such as one focused on mood, energy use, exercise, or diet. You may be screened again after finishing that study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Confirmed MS diagnosis of any subtype 2. Score of 4 or higher on the Fatigue Severity Scale 3. Able to fluently converse and read in English 4. 18 years of age or older 5. Able to comply with study procedures and complete self-report measures 6. Willing to have intervention sessions audiotaped for fidelity coding 7. Has experienced fatigue for 3 or more months Exclusion Criteria: 1. MS relapse within last 30 days (although participants will be considered eligible after the 30-day window) 2. Change in disease modifying medications (DMTs) in the prior three months (although participants will be considered eligible after the 3-month window) 3. Current suicidal ideation with intent or plan as indicated by a score of ≥1 on the Patient Health Questionnaire-9 suicide item and further assessment via the Columbia Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible) 4. Currently engaged in psychotherapy for fatigue 5. Currently participating in another research study that could impact fatigue such as intervention studies targeting mood, energy management, exercise/physical activity, and diet (although participants can be screened for eligibility again once they have completed the other research study)

Study sites (1)

WA