Factorial Optimization Trial to Test Cognitive Behavioral Therapy Comp

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

RecruitingNot a drug-phase studyMS (type not specified)NCT06809192

What it found

Still running

No result yet.

What was tested

Treatment tested

  • 4-session Relaxation Training
  • 4-session Behavioral Activation
  • 4-session Cognitive Therapy

What it measured

Main measures

  • Modified Fatigue Impact Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

    Fatigue

  • PROMIS Short Form - Ability to Participate in Social Roles and Activities

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

Other measures (15)

  • Perceived Stress Questionnaire - Tension scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

  • Behavioral Activation for Depression Scale Short Form

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

    Mood and sleep

  • Fatigue Catastrophizing Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

    Fatigue

  • The Multiple Sclerosis-Fatigue Self Efficacy Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

    Fatigue

  • Perceived Stress Scale

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

  • Positive and Negative Affect Schedule

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

  • PROMIS Emotional Distress-Depression - Short Form 4a

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

    Mood and sleep

  • EQ-5D-5L

    Collected via online survey at baseline/pre-treatment, post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition), and 3-month f

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Global Impression of Change Scale

    Collected via online survey at post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition).

    Quality of life (reported by participants)

  • Global Assessment of Treatment Satisfaction

    Collected via online survey at post-treatment (3 days after last treatment session or 2 months post-randomization for participants in the No Treatment condition).

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2025

    2. Main results due

      Dec 2026

    3. Finished

      Mar 2027

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