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Multiple SclerosisPhase 2CALMNCT06428006

Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

A Phase 2 study testing Cognitive behavioral therapy for insomnia and Sleep and lifestyle education in people with Multiple Sclerosis and Insomnia, run by University of Kansas Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis, Insomnia
What is being tested?
Cognitive behavioral therapy for insomnia and Sleep and lifestyle education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
30 Jul 2024to 31 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 years old
  • Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist
  • Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
  • Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
  • ≥10 on Insomnia Severity Index
  • English speaking
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  • ≥31 on modified Telephone Interview of Cognitive Status23
  • Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
  • Report having access to internet service or a data plan and access to a computer, tablet, or smart phone

Who cannot join

  • Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
  • >3 on STOP BANG indicating increased risk of sleep apnea
  • Restless legs syndrome as determined by RLS-Diagnosis Index
  • Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
  • Parasomnia as determined by the Sleep Disorders-Revised
  • Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia
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  • Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
  • Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
  • Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
  • History of other nervous system disorder such as stroke or Parkinson's disease
  • Currently pregnant or intending to become pregnant in the next 6 months
  • Severe mental illness such as schizophrenia or bipolar disorder
  • Severe neurological or sensory impairments that would interfere significantly with testing
  • Relapse and/or corticosteroid use in the past 8 weeks
  • History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
  • Currently receiving a behavioral sleep health intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

Being tested
Cognitive behavioral therapy for insomnia, Sleep and lifestyle education
Keywords
Cognitive behavioral therapy for insomnia, CBT-I
Medical subject headings
Multiple Sclerosis, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioral therapy for insomniaBehavioural

    The general sessions outlines are as follows with each session:

    Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention

  • Sleep and lifestyle educationBehavioural

    The general sessions outlines are as follows with each session:

    Session 1: Basic sleep education, stretching exercises Session 2: Sleep hygiene education (environmental factors \& sleep positions), stretching exercises Session 3: Sleep hygiene education (lifestyle factors), stretching exercises Session 4: Diet recommendations, stretching exercises Session 5: Exercises recommendations, stretching exercises Session 6: Discus maintaining achievements \& preventing relapses, stretching exercises

Study groups in NCT06428006
Study groupRoleWhat they receive
Cognitive behavioral therapy for insomniaExperimental1x/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.
Receives: Behavioral: Cognitive behavioral therapy for insomnia
Sleep and lifestyle educationActive comparator1x/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.
Receives: Behavioral: Sleep and lifestyle education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia Severity Index (ISI)

    The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.

    Measured: baseline, Week 6, Month 6

Secondary outcomes (10)

  1. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of >5 reflects poor sleep quality.

    Measured: baseline, Week 6, Month 6

  2. Epworth Sleepiness Scale (ESS)

    Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.

    Measured: baseline, Week 6, Month 6

  3. Dysfunctional Beliefs About Sleep

    This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.

    Measured: baseline, Week 6, Month 6

  4. Positive Affect and Negative Affect Schedule (PANAS)

    is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions.

    Measured: baseline, Week 6, Month 6

  5. Sleep Self-Efficacy Scale (SESS)

    Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.

    Measured: baseline, Week 6, Month 6

  6. Actigraphy

    Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration

    Measured: baseline, Week 6, Month 6

  7. Modified Fatigue Impact Scale (MFIS)

    The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.

    Measured: baseline, Week 6, Month 6

  8. Fatigue Severity Scale (FSS)

    The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.

    Measured: baseline, Week 6, Month 6

  9. Multiple Sclerosis Impact Scale (MSIS-29)

    Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS

    Measured: baseline, Week 6, Month 6

  10. Cognitive Failures Questionnaire (CFQ)

    Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.

    Measured: baseline, Week 6, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start30 Jul 2024
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06428006
Sponsor's protocol ID
STUDY00160476
Acronym
CALM
Status last verified
Oct 2026
First submitted
13 May 2024
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siengsukon CF, Robichaud J, Nelson E, Glaser A, Baber GR, Gratton MKP, Zanotto A, Phadnis MA, Lynch S. Cognitive behavioral therapy for insomnia for individuals with multiple sclerosis (CALM): A randomized control trial protocol. Contemp Clin Trials Commun. 2026 Jan 10;49:101595. doi: 10.1016/j.conctc.2026.101595. eCollection 2026 Feb.

    PubMed 41626064

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cognitive behavioral therapy for insomnia and Sleep and lifestyle education in people with Multiple Sclerosis and Insomnia, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: baseline, Week 6, Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06428006, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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