Cognitive Behavioral Therapy for Insomnia in Multiple Sclerosis

(CALM Trial)

Overseen By Catherine Siengsukon, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must not be taking: Benzodiazepines, Non-benzodiazepines, Melatonin

Disqualifiers: Sleep apnea, Severe depression, Severe anxiety, Alcohol abuse, Schizophrenia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cognitive behavioral therapy for insomnia (CBT-I) to determine its effectiveness for people with multiple sclerosis (MS) who struggle with sleep. The study aims to assess whether CBT-I can improve sleep issues, reduce fatigue, and enhance participants' quality of life compared to a program offering sleep and lifestyle education. It includes weekly one-on-one sessions via video calls over six weeks. Suitable candidates have MS and experience frequent sleep problems, such as difficulty falling or staying asleep, at least three nights a week for the past three months. Participants should have internet access and a device for video conferencing. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications for this trial?

The trial requires that you are not currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia. If you are taking these, you would need to stop before participating.

What prior data suggests that cognitive behavioral therapy for insomnia is safe for individuals with multiple sclerosis?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally easy for participants to handle. Studies have found that CBT-I helps people sleep better, feel less tired, and improves their overall quality of life if they have trouble sleeping.

For example, one study found that participants reported better sleep and felt less tired and depressed after trying CBT-I. Another study showed that older adults benefited from digital CBT-I, indicating it can be a flexible and effective treatment.

While the studies mainly focus on the benefits, they also suggest that serious side effects are rare. This reassures those considering joining a CBT-I trial, as it suggests a safe track record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) in treating sleep issues in people with Multiple Sclerosis (MS) because it offers a personalized, medication-free approach. Unlike standard treatments for insomnia, which often involve sleep medications, CBT-I uses techniques like time in bed restriction, stimulus control, relaxation strategies, and cognitive restructuring to improve sleep naturally. Delivered through video conferencing, it provides convenient access to therapy, making it easier for people with MS to participate from home. This approach not only targets sleep problems but also promotes overall sleep health, potentially leading to more sustainable and long-term improvements.

What evidence suggests that cognitive behavioral therapy for insomnia is effective for improving insomnia symptoms in individuals with multiple sclerosis?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can improve sleep for people with multiple sclerosis (MS). One study found that 86% of MS patients who tried CBT-I experienced fewer insomnia symptoms. Another study revealed that CBT-I not only alleviated insomnia but also reduced fatigue and depression, while increasing total sleep time. CBT-I appears promising for addressing sleep problems in MS, enhancing sleep quality, reducing tiredness, and boosting overall quality of life. These findings suggest CBT-I could be an effective treatment for insomnia in people with MS. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-65 with relapsing-remitting or secondary progressive Multiple Sclerosis who experience insomnia symptoms at least three nights a week for the past three months. Participants should have mild-to-moderate disability, be English-speaking, and have internet access plus a suitable device.

Inclusion Criteria

≥31 on modified Telephone Interview of Cognitive Status

Has a high school diploma or equivalent

≥10 on Insomnia Severity Index

Exclusion Criteria

Current or history (up to 2 years) of alcohol or drug abuse as indicated by DSM-5 criteria

Severe mental illness such as schizophrenia or bipolar disorder

Severe neurological or sensory impairments that would interfere significantly with testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy for insomnia (CBT-I) or sleep and lifestyle education once a week for 6 weeks via video conferencing

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, Week 6, and Month 6

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview

The study aims to test if Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep, reduce fatigue, and enhance quality of life in MS patients compared to an active control group that receives only sleep and lifestyle education.

How Is the Trial Designed?

Group I: Cognitive behavioral therapy for insomnia Experimental Treatment 1 Intervention

1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.

Group II: Sleep and lifestyle education Active Control 1 Intervention

1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education.

Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Approved in United States as Somryst for:

• Chronic Insomnia

Approved in United Kingdom as Sleepio for:

• Insomnia

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

Digital cognitive behavioral therapy for insomnia (dCBT-I) was found to be more effective than medication alone in reducing insomnia symptoms, with significant improvements in Pittsburgh Sleep Quality Index scores over 6 months for dCBT-I and combination therapy.

While dCBT-I showed comparable effectiveness to combination therapy, its benefits were less stable over time, indicating that while it is a strong treatment option, further research is needed to understand its long-term reliability in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. Lu, M., Zhang, Y., Zhang, J., et al.[2023]

Digital cognitive behavioural therapy for insomnia (dCBT-I) significantly reduces insomnia severity, with a mean difference of -5.00 on the Insomnia Severity Index (ISI) immediately after treatment, based on a meta-analysis of 33 studies involving nearly 9,400 participants.

The benefits of dCBT-I are sustained over time, showing continued improvement at both short-term (4 weeks to 6 months) and 1-year follow-ups, making it a promising alternative to traditional face-to-face therapy, which, while slightly more effective, falls within a non-inferiority margin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. Soh, HL., Ho, RC., Ho, CS., et al.[2021]

In a study of 127 multiple sclerosis patients with depression, the prevalence of insomnia was found to be very high at 78% before treatment, but significantly decreased to 43% after a 16-week psychotherapy intervention, indicating that targeted therapy can effectively reduce insomnia symptoms.

Insomnia was closely linked to depression and anxiety, and patients with ongoing insomnia after treatment were more likely to experience severe multiple sclerosis symptoms and lower quality of life, suggesting that additional treatments specifically for insomnia may be necessary alongside psychological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of psychotherapy on insomnia symptoms in patients with depression and multiple sclerosis. Baron, KG., Corden, M., Jin, L., et al.[2022]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

A study involving 41 individuals with multiple sclerosis (MS) demonstrated that a 6-week Web-based cognitive behavioral therapy for insomnia (CBT-I) program significantly improved insomnia severity, sleep quality, and anxiety, making it a feasible treatment option for those with mobility issues or living in remote areas.

The Web-based CBT-I program was effective in enhancing sleep outcomes, with notable improvements in depression and fatigue observed only in the group that received the program without additional telephone support, suggesting that the online format alone can be beneficial for managing insomnia in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Treatment Effect of a Web-Based Cognitive Behavioral Therapy for Insomnia Program in Individuals with Multiple Sclerosis: A Pilot Randomized Controlled Trial. Siengsukon, CF., Beck, ES., Drerup, M.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is feasible for individuals with multiple sclerosis (MS) and shows promising improvements in insomnia severity, sleep quality, and symptoms of fatigue and depression, based on a pilot study with 33 participants.

The study found that while all groups improved their insomnia symptoms, only the CBT-I group showed significant enhancements in sleep self-efficacy and depression, suggesting that CBT-I may offer unique benefits beyond general sleep education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and treatment effect of cognitive behavioral therapy for insomnia in individuals with multiple sclerosis: A pilot randomized controlled trial. Siengsukon, CF., Alshehri, M., Williams, C., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) improved sleep efficiency and reduced time in bed for individuals with multiple sclerosis, as measured by both sleep logs and actigraphy in a study of 25 participants.

The results suggest that CBT-I can enhance sleep outcomes in people with MS, but further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Cognitive Behavioral Therapy for Insomnia on Sleep Log and Actigraphy Outcomes in People with Multiple Sclerosis: A Secondary Analysis. Williams-Cooke, C., LeSuer, L., Drerup, M., et al.[2022]

Individuals with multiple sclerosis (MS) experience sleep disorders, particularly insomnia, at a rate 3-5 times higher than the general population, which significantly contributes to fatigue, a major symptom of MS.

Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia in MS patients, and this review discusses how to adapt standard insomnia treatments to better suit the unique needs of individuals with MS, considering their level of disability and other health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Approaches to Insomnia and Fatigue in Patients with Multiple Sclerosis. Drerup, M., Roth, A., Kane, A., et al.[2021]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

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