Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue
Recruiting in Palo Alto (17 mi)
Overseen byLindsey Knowles, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Disqualifiers: MS relapse, Suicidal ideation, Psychotherapy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not have changed your disease modifying medications in the past three months to be eligible.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue?
Research shows that cognitive behavioral therapy (CBT) is effective in reducing fatigue in multiple sclerosis (MS) patients. A study found that CBT was more effective than relaxation training in decreasing MS fatigue, and other studies confirm CBT's positive impact on fatigue management.
12345Is Cognitive Behavioral Therapy safe for treating fatigue in Multiple Sclerosis?
The research does not specifically address safety concerns, but Cognitive Behavioral Therapy (CBT) is generally considered safe for treating various conditions, including fatigue in Multiple Sclerosis. It is a non-invasive therapy that focuses on changing negative thought patterns and behaviors.
12346How does the treatment Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue differ from other treatments?
This treatment is unique because it combines Behavioral Activation, Cognitive Therapy, and Relaxation Training to specifically target the thoughts and behaviors that perpetuate fatigue in multiple sclerosis, rather than just addressing physical symptoms. Unlike some medications, this approach has shown effectiveness in reducing fatigue by changing how patients think and behave, and it can be delivered face-to-face or through an internet-based program, making it more accessible.
12347Eligibility Criteria
This trial is for adults with multiple sclerosis who experience fatigue. It's not specified, but typically participants should be in stable health aside from their MS and fatigue symptoms.Inclusion Criteria
I am 18 years old or older.
I have been diagnosed with multiple sclerosis.
Able to fluently converse and read in English
+4 more
Exclusion Criteria
I have had an MS flare-up in the last 30 days.
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)
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)
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive telehealth CBT components including Relaxation Training, Behavioral Activation, and Cognitive Therapy for multiple sclerosis fatigue
8-16 weeks
4 sessions per component, delivered via phone or videoconference
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Patient-reported outcome measures collected at 3-month follow-up
Participant Groups
The study tests three different short therapies: cognitive therapy to change thought patterns, relaxation training to reduce stress, and behavioral activation to increase engagement in activities. The goal is to see which helps most with MS-related fatigue.
8Treatment groups
Experimental Treatment
Active Control
Group I: Relaxation Training, Behavioral Activation, and Cognitive TherapyExperimental Treatment3 Interventions
4 sessions of telehealth Relaxation Training, 4 sessions of telehealth Behavioral Activation, and 4 sessions of telehealth Cognitive Therapy for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.
Group II: Relaxation Training onlyExperimental Treatment1 Intervention
A 4-session telehealth Relaxation Training intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis and the cognitive behavioral model of multiple sclerosis fatigue, b) treatment rationale, c) didactic and experiential training in relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation, and autogenic relaxation, and d) goal setting and problem-solving barriers to integrate relaxation practices into daily routine.
Group III: Relaxation Training and Cognitive TherapyExperimental Treatment2 Interventions
4 sessions of telehealth Relaxation Training and 4 sessions of telehealth Cognitive Therapy for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.
Group IV: Relaxation Training and Behavioral ActivationExperimental Treatment2 Interventions
4 sessions of telehealth Relaxation Training and 4 sessions of telehealth Behavioral Activation for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.
Group V: Cognitive Therapy onlyExperimental Treatment1 Intervention
A 4-session telehealth Cognitive Therapy intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, self-monitoring thoughts, and core beliefs, b) treatment rationale, c) labeling thoughts as helpful, unhelpful, or neutral, d) using distraction to cope with unhelpful thoughts, e) challenging and changing unhelpful thoughts, f) problem-solving barriers to coping with or changing unhelpful thoughts.
Group VI: Behavioral Activation onlyExperimental Treatment1 Intervention
A 4-session telehealth Behavioral Activation intervention for multiple sclerosis fatigue that is derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. The intervention is based on the cognitive behavioral model of fatigue in multiple sclerosis. The intervention involves 4, 30-60-minute sessions including the following content a) education about fatigue in multiple sclerosis, the cognitive behavioral model of multiple sclerosis fatigue, and self-monitoring activity and energy, b) treatment rationale, c) identification of values/priorities to guide activities, d) activity planning, e) goal setting and problem-solving barriers to engaging in activities.
Group VII: Behavioral Activation and Cognitive TherapyExperimental Treatment2 Interventions
4 sessions of telehealth Behavioral Activation and 4 sessions of telehealth Cognitive Therapy for multiple sclerosis fatigue that are derived from evidence-based multicomponent CBT for multiple sclerosis fatigue. Each intervention involves 4, 30-60-minute sessions delivered via phone or videoconference.
Group VIII: No TreatmentActive Control1 Intervention
Participants in the "No Treatment" condition will not complete any component sessions and will complete assessments at baseline (within 1 month of randomization), at approximately 2 months after randomization (the weighted average of weeks of treatment in the other conditions), and 3-month follow-up (dated from randomization). Upon study completion, these participants will be offered the opportunity to complete a component of their choice (Relaxation Training, Behavioral Activation, or Cognitive Therapy).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Multiple Sclerosis Center at UW Medical Center - NorthwestSeattle, WA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? [2022]Chronic fatigue is a common symptom of multiple sclerosis (MS). A randomized controlled trial (RCT) showed that cognitive behavioural therapy (CBT) was more effective in reducing MS fatigue than relaxation training (RT). The aim of the current study was to analyse additional data from this trial to determine whether (1) CBT compared to RT leads to significantly greater changes in cognitions and behaviours hypothesized to perpetuate MS fatigue; (2) changes in these variables mediate the effect of CBT on MS fatigue; and (3) these mediation effects are independent of changes in mood.
Fatigue and multiple sclerosis. [2006]Even if the definition and pathophysiology of fatigue in multiple sclerosis (MS) are still debated, and despite the scarcity of objective markers correlated with the subjective sensation of fatigue, a review of the literature shows the importance of its detection and management, and allows one to propose therapeutic strategies. Fatigue is not only the most frequently reported symptom in MS, but also a frequent source of activity and participation limitations, psychological distress, and impairment of quality of life. Its management, which must be initiated early, is based on a comprehensive evaluation of its characteristics and consequences (sometimes with the use of scales such as the Fatigue Severity Scale and the Modified Fatigue Impact Scale), and on the identification of many potential contributing factors (psychological disorders, sleep disturbances, pain, infections and other comorbidities, medications, and deconditioning). Rehabilitative interventions are essential to the treatment of fatigue. Beyond the traditional energy conservation strategies and cooling techniques, several randomized controlled studies have demonstrated the positive impact of aerobic exercise. Medications are partially beneficial, and with the exception of amantadine, their efficacy has not been confirmed by randomized double-blind trials.
Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT. [2023]Cognitive behavioural therapy (CBT) reduces multiple sclerosis (MS)-related fatigue. Implementation of face-to-face CBT is hindered by limited treatment capacity and traveling distances to treatment locations.
Cognitive behavioural therapy for MS-related fatigue explained: A longitudinal mediation analysis. [2019]Cognitive behavioural therapy (CBT) effectively reduces fatigue directly following treatment in patients with Multiple Sclerosis (MS), but little is known about the process of change during and after CBT.
The Berlin Treatment Algorithm: recommendations for tailored innovative therapeutic strategies for multiple sclerosis-related fatigue. [2020]More than 80% of multiple sclerosis (MS) patients suffer from fatigue. Despite this, there are few therapeutic options and evidence-based pharmacological treatments are lacking. The associated societal burden is substantial (MS fatigue is a major reason for part-time employment or early retirement), and at least one out of four MS patients view fatigue as the most burdensome symptom of their disease. The mechanisms underlying MS-related fatigue are poorly understood, and objective criteria for distinguishing and evaluating levels of fatigue and tiredness have not yet been developed. A further complication is that both symptoms may also be unspecific indicators of many other diseases (including depression, sleep disorders, anemia, renal failure, liver diseases, chronic obstructive pulmonary disease, drug side effects, recent MS relapses, infections, nocturia, cancer, thyroid hypofunction, lack of physical exercise). This paper reviews current treatment options of MS-related fatigue in order to establish an individualized therapeutic strategy that factors in existing comorbid disorders. To ensure that such a strategy can also be easily and widely implemented, a comprehensive approach is needed, which ideally takes into account all other possible causes and which is moreover cost efficient. Using a diagnostic interview, depressive disorders, sleep disorders and side effects of the medication should be identified and addressed. All MS patients suffering from fatigue should fill out the Modified Fatigue Impact Scale, Epworth Sleepiness Scale, the Beck Depression Inventory (or a similar depression scale), and the Pittsburgh Sleep Quality Index (or the Insomnia Severity Index). In some patients, polygraphic or polysomnographic investigations should be performed. The treatment of underlying sleep disorders, drug therapy with alfacalcidol or fampridine, exercise therapy, and cognitive behavioral therapy-based interventions may be effective against MS-related fatigue. The objectives of this article are to identify the reasons for fatigue in patients suffering from multiple sclerosis and to introduce individually tailored treatment approaches. Moreover, this paper focuses on current knowledge about MS-related fatigue in relation to brain atrophy and lesions, cognition, disease course, and other findings in an attempt to identify future research directions.
A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. [2022]The purpose of this study was to assess the efficacy of cognitive behavior therapy (CBT) as a treatment for multiple sclerosis (MS) fatigue.
A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue. [2022]The majority of people affected by Multiple Sclerosis (paMS) experience severe and disabling fatigue. A recent randomised controlled trial (RCT) showed that cognitive behaviour therapy with a clinical psychologist was an effective treatment for MS fatigue. An Internet-based version of this intervention, MS Invigor8, was developed for the current study using agile design and input from paMS. MS Invigor8 includes eight tailored, interactive sessions. The aim was to test the feasibility and potential efficacy and cost-effectiveness of the programme in a pilot RCT. 40 patients were randomised to MS Invigor8 (n=23) or standard care (n=17). The MS Invigor8 group accessed sessions over 8-10 weeks and received up to three 30-60min telephone support sessions. Participants completed online standardised questionnaires assessing fatigue, mood, quality of life and service use at baseline and 10 weeks follow-up. Large between group treatment effects were found for the primary outcomes of fatigue severity (d=1.19) and impact (d=1.02). The MS Invigor8 group also reported significantly greater improvements in anxiety, depression and quality-adjusted life years. These data suggest that Internet-based CBT may be a clinically and cost-effective treatment for MS fatigue. A larger RCT with longer term follow-up is warranted.