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New treatment option for Multiple Sclerosis
Official title Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue
ClinicalTrials.gov ID: NCT06809192
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed MS diagnosis of any subtype
- Score of 4 or higher on the Fatigue Severity Scale
- Able to fluently converse and read in English
- 18 years of age or older
- Able to comply with study procedures and complete self-report measures
You likely can't join if
- MS relapse within last 30 days (although participants will be considered eligible after the 30-day window)
- Change in disease modifying medications (DMTs) in the prior three months (although participants will be considered eligible after the 3-month window)
- 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...
- Currently engaged in psychotherapy for fatigue
- Currently participating in another research study that could impact fatigue such as intervention studies targeting mood, energy management...
See the full eligibility criteria
- Confirmed MS diagnosis of any subtype
- Score of 4 or higher on the Fatigue Severity Scale
- Able to fluently converse and read in English
- 18 years of age or older
- Able to comply with study procedures and complete self-report measures
- Willing to have intervention sessions audiotaped for fidelity coding
- Has experienced fatigue for 3 or more months
- MS relapse within last 30 days (although participants will be considered eligible after the 30-day window)
- Change in disease modifying medications (DMTs) in the prior three months (although participants will be considered eligible after the 3-month window)
- 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...
- Currently engaged in psychotherapy for fatigue
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.