Prospective Case Series to Refine Standalone Cognitive Behavioral Ther

Prospective Case Series to Refine Standalone Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

CompletedNot a drug-phase studyMS (type not specified)NCT05848323

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

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

Results by group

Intervention Acceptability

Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

GroupValueIntervalNumber analysed
Relaxation Training4.36 Units on a scale0.7 (Standard Deviation)7
Behavioral Activation4.64 Units on a scale0.48 (Standard Deviation)7
Cognitive Therapy4.68 Units on a scale0.59 (Standard Deviation)7

Relaxation Training

4.36

Behavioral Activation

4.64

Cognitive Therapy

4.68

Intervention Appropriateness

Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

GroupValueIntervalNumber analysed
Relaxation Training4.14 Units on a scale0.57 (Standard Deviation)7
Behavioral Activation4.25 Units on a scale0.74 (Standard Deviation)7
Cognitive Therapy4.25 Units on a scale0.78 (Standard Deviation)7

Relaxation Training

4.14

Behavioral Activation

4.25

Cognitive Therapy

4.25

Intervention Feasibility

Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

GroupValueIntervalNumber analysed
Relaxation Training4.46 Units on a scale0.57 (Standard Deviation)7
Behavioral Activation4.39 Units on a scale0.61 (Standard Deviation)7
Cognitive Therapy4.42 Units on a scale0.66 (Standard Deviation)7

Relaxation Training

4.46

Behavioral Activation

4.39

Cognitive Therapy

4.42

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Relaxation Training70 (0.0%)0
Behavioral Activation70 (0.0%)0
Cognitive Therapy70 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Intervention Acceptability

    Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Feasibility

  • Intervention Appropriateness

    Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

  • Intervention Feasibility

    Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Feasibility

Other measures (7)

  • Fatigue

    Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Fatigue

  • Participation in Social Roles and Activities

    Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Quality of life (reported by participants)

  • Relaxation/Serenity

    Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).

  • Fatigue Catastrophizing

    Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Fatigue

  • Behavioral Activation

    Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Mood and sleep

  • Cognitive Behavioural Responses Questionnaire - Short Form

    Collected via online survey at pre-treatment (up to 4 weeks before treatment session 1) and post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Thinking and memoryFatigueBladder, bowel and sexual function

  • Global Impression of Change

    Collected via online survey at post-treatment (approximately 4-8 weeks after the pre-treatment survey).

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

1. MS diagnosis of any subtype per chart review 2. Score 4 or higher on the Fatigue Severity Scale 3. Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for 3 or more months 4. Are able to comply with study procedures and complete measures independently assessed via self-report 5. All genders 6. 18 years of age or older 7. Able to read and speak English 8. Are willing to maintain current fatigue treatment regimen for duration of study (although individuals who want to make a change to their fatigue treatment regimen will be considered eligible 3 months after making that change)

Exclusion criteria

1. Score greater than 7 on the Patient Determined Disease Steps Scale 2. Has significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener 3. Change in disease modifying medications in the prior three months assessed via self-report (although participants will be considered eligible after the 3-month window) 4. History of MS relapse within the last 30 days prior to screening assessed via self-report (although participants will be considered eligible after the 30-day window) 5. Current suicidal ideation with intent or plan as indicated by a score of 1 or higher on the Patient Health Questionnaire-9 suicide item and further assessment with the Columbia-Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible) 6. Currently engaged in psychotherapy for fatigue assessed via self-report 7. Current pregnancy (although participants will be considered eligible when they are no longer pregnant) 8. 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 once they have completed the other research study).

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

About this trial

In the sponsor's words

This prospective case series will use mixed methods to examine the feasibility, acceptability, and initial effects of three telehealth cognitive behavioral therapy components (relaxation training, behavioral activation, cognitive therapy) for fatigue in people with multiple sclerosis.

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History

    1. Started

      Oct 2023

    2. Main results due

      Sept 2024

    3. Finished

      Sept 2024

    4. Results posted

      Nov 2025

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