Cognitive Behavioral Therapy for Multiple Sclerosis Fatigue

Overseen By Dawn Ehde, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: MS relapse, Suicidal ideation, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8-16 weeks

112 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{1 2 3 4 7}

Research Team

Lindsey Knowles, PhD

Principal Investigator

University of Washington

Eligibility 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 have been diagnosed with multiple sclerosis.

Able to fluently converse and read in English

Able to comply with study procedures and complete self-report measures

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)

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

Treatment Details

Interventions

• Behavioral Activation
• Cognitive Therapy
• Relaxation Training

Trial Overview 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.

Participant Groups

Group I: Relaxation Training, Behavioral Activation, and Cognitive Therapy Experimental Treatment 3 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 only Experimental Treatment 1 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 Therapy Experimental Treatment 2 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 Activation Experimental Treatment 2 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 only Experimental Treatment 1 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 only Experimental Treatment 1 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 Therapy Experimental Treatment 2 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 Treatment Active Control 1 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).

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Cognitive Behavioral Therapy (CBT) significantly improved cognitive and behavioral factors related to fatigue in multiple sclerosis patients compared to Relaxation Training (RT), with 70 participants involved in the study.

Changes in negative beliefs about fatigue were found to mediate the reduction in fatigue severity, indicating that addressing these beliefs is crucial for the effectiveness of CBT, independent of mood improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? Knoop, H., van Kessel, K., Moss-Morris, R.[2022]

Fatigue is the most common symptom reported by people with multiple sclerosis (MS) and significantly affects their quality of life, making its early detection and management crucial.

Rehabilitative interventions, particularly aerobic exercise, have shown positive effects on managing fatigue in MS, while medications like amantadine may offer some benefits, though their efficacy lacks strong evidence from randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatigue and multiple sclerosis. Béthoux, F.[2006]

Blended cognitive behavioural therapy (CBT), which combines online modules with therapist support, was found to be non-inferior to traditional face-to-face CBT in reducing fatigue severity in 166 patients with multiple sclerosis, demonstrating its effectiveness as an alternative treatment.

The blended approach not only maintained treatment efficacy but also significantly reduced the time therapists spent with patients, making it a more efficient option without any reported harm related to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT. de Gier, M., Beckerman, H., Twisk, J., et al.[2023]

Cognitive Behavioral Therapy (CBT) significantly reduces fatigue in patients with Multiple Sclerosis (MS) during treatment, with improvements linked to better fatigue perceptions, increased physical activity, and enhanced physical functioning.

Post-treatment, maintaining low fatigue levels is associated with continued focus on physical activity, concentration, and managing sleepiness, suggesting these factors are crucial for sustaining the benefits of CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for MS-related fatigue explained: A longitudinal mediation analysis. van den Akker, LE., Beckerman, H., Collette, EH., et al.[2019]

Over 80% of multiple sclerosis (MS) patients experience fatigue, which significantly impacts their quality of life and employment, yet effective pharmacological treatments are limited and poorly understood.

A comprehensive, individualized treatment strategy for MS-related fatigue should include identifying comorbid conditions, utilizing specific assessment scales, and considering therapies such as exercise, cognitive behavioral therapy, and medications like alfacalcidol or fampridine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Berlin Treatment Algorithm: recommendations for tailored innovative therapeutic strategies for multiple sclerosis-related fatigue. Veauthier, C., Hasselmann, H., Gold, SM., et al.[2020]

Cognitive behavior therapy (CBT) significantly reduced fatigue in patients with multiple sclerosis (MS) more than relaxation training (RT) over an 8-month period, with a large effect size of 3.03 for CBT compared to 1.83 for RT.

Both CBT and RT were effective in reducing fatigue to levels comparable to those of healthy individuals, indicating that both therapies can provide meaningful relief for MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. van Kessel, K., Moss-Morris, R., Willoughby, E., et al.[2022]

A pilot randomized controlled trial involving 40 patients with Multiple Sclerosis demonstrated that the Internet-based cognitive behavior therapy program, MS Invigor8, significantly reduced fatigue severity and impact compared to standard care, with large treatment effects (d=1.19 for severity and d=1.02 for impact).

Participants in the MS Invigor8 group also experienced notable improvements in anxiety, depression, and overall quality of life, suggesting that this online intervention could be a clinically effective and cost-effective option for managing MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue. Moss-Morris, R., McCrone, P., Yardley, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fatigue and multiple sclerosis. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis: A non-inferiority RCT. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for MS-related fatigue explained: A longitudinal mediation analysis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Berlin Treatment Algorithm: recommendations for tailored innovative therapeutic strategies for multiple sclerosis-related fatigue. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A pilot randomised controlled trial of an Internet-based cognitive behavioural therapy self-management programme (MS Invigor8) for multiple sclerosis fatigue. [2022]