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Cognitive Behavioral Therapy for MS Fatigue

N/A
Recruiting
Led By Lindsey Knowles, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
MS diagnosis of any subtype per chart review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
Awards & highlights

Study Summary

This trial will look at telehealth therapy for fatigue in people with MS, testing how well it works and how acceptable it is.

Who is the study for?
This trial is for adults of any gender with Multiple Sclerosis who feel very tired, can read and speak English, and are able to follow the study's procedures on their own. They must have a score of 10 or higher on a fatigue scale.Check my eligibility
What is being tested?
The trial tests three separate telehealth treatments over four weeks each: Relaxation Training, Behavioral Activation, and Cognitive Therapy. These aim to see if they help reduce fatigue in people with Multiple Sclerosis.See study design
What are the potential side effects?
Since these interventions involve therapy sessions rather than drugs, side effects may include discomfort from discussing personal issues or temporary increases in distress as new coping strategies are learned.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I have been diagnosed with multiple sclerosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected via online survey at pre-treatment (up to 1 month before treatment session 1) and post-treatment (up to 1 month after treatment session 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention Acceptability
Intervention Appropriateness
Intervention Feasibility
Secondary outcome measures
Behavioral Activation
Cognitive Behavioural Responses Questionnaire - Short Form
Fatigue
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Relaxation TrainingExperimental Treatment1 Intervention
Didactic and experiential training in one or more relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, autogenic relaxation, and guided imagery to reduce autonomic nervous system arousal.
Group II: Cognitive TherapyExperimental Treatment1 Intervention
Didactic material and practice focused on identifying, challenging, and modifying inaccurate and/or unhelpful patterns of thought about the self and the world (e.g., catastrophizing the meaning and consequences of fatigue) to change unwanted behavioral patterns (e.g., excessive rest).
Group III: Behavioral ActivationExperimental Treatment1 Intervention
Didactic material and practice focused on identification and reduction of avoidance behaviors (e.g., excessive rest) and increased engagement in valued and reinforcing activities (e.g., physical activity, social engagement).

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,745 Total Patients Enrolled
23 Trials studying Multiple Sclerosis
3,625 Patients Enrolled for Multiple Sclerosis
Lindsey Knowles, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
51 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are contributing to this medical experiment?

"Indeed, the records on clinicaltrials.gov demonstrate that this research project is currently seeking participants. It was initially listed on October 23rd 2023 and its information was most recently updated on November 27th of the same year. The study requires 21 subjects from 1 medical setting."

Answered by AI

Is access to this medical experiment available at the present moment?

"Indeed, clinicaltrials.gov records confirm that this research project is currently recruiting patients; it was initiated on October 23rd 2023 and last updated November 27th 2023. 21 participants are sought from a single medical centre."

Answered by AI

What goals are researchers aiming to achieve with this trial?

"This medical trial seeks to evaluate the feasibility of an intervention. The primary outcome will be assessed via online surveys one month after session 4 while secondary objectives include measuring fatigue catastrophizing, cognitive and behavioural responses to fatigue, as well as global impression of change."

Answered by AI
~7 spots leftby Jul 2024