Multiple SclerosisPhase 2CLEARNCT06434571
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
A Phase 2 study testing Telehealth cognitive behavioral therapy for insomnia (tCBT-I), Web-based cognitive behavioral therapy for insomnia (wCBT-I) and Treatment as usual (TAU) in people with Multiple Sclerosis and Insomnia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of… 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?
- Telehealth cognitive behavioral therapy for insomnia (tCBT-I), Web-based cognitive behavioral therapy for insomnia (wCBT-I) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2024to 31 Jul 2028
- 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 guidelines21 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
Show all 9Show fewer
- ≥31 on Telephone Interview of Cognitive Status
- 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
- If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months
Show all 16Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center- Sleep, Health and Wellness Laboratory
Kansas City, Kansas, 66160
Eryen Nelson, MPH, 913-945-7349, enelson5@kumc.edu
Catherine Siengsukon, PT, PhD
About this study
Official title: Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.
- Conditions
- Multiple Sclerosis, Insomnia
- Being tested
- Telehealth cognitive behavioral therapy for insomnia (tCBT-I), Web-based cognitive behavioral therapy for insomnia (wCBT-I), Treatment as usual (TAU)
- 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.
Telehealth cognitive behavioral therapy for insomnia (tCBT-I)Behavioural
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
Web-based cognitive behavioral therapy for insomnia (wCBT-I)Behavioural
Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program.
Treatment as usual (TAU)Behavioural
They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth cognitive behavioral therapy for insomnia (tCBT-I) | Experimental | 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. Receives: Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I) |
| Web-based cognitive behavioral therapy for insomnia (wCBT-I) | Experimental | The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total) Receives: Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I) |
| Treatment as usual (TAU) | Other | The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment. Receives: Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, Week 12
Secondary outcomes (11)
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
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
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
Positive Affect and Negative Affect Schedule (PANAS)
The 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
Sleep Self-Efficacy Scale (SESS)
The SESS 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
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
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
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
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
Cognitive Failures Questionnaire (CFQ)
The 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
plasma neurofilament light (NfL)
blood marker of axonal damage
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.
- First posted30 May 2024
- Study start11 Oct 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Siengsukon, PT, PhD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434571
- Sponsor's protocol ID
- STUDY00160591
- Acronym
- CLEAR
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
- ClinicalTrials.gov ID
- NCT06434571
- Acronym / sponsor ID
- CLEAR / STUDY00160591
- Conditions
- Multiple Sclerosis, Insomnia
- Keywords
- Cognitive behavioral therapy for insomnia, CBT-I
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telehealth cognitive behavioral therapy for insomnia (tCBT-I) | Experimental | Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)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. |
| Web-based cognitive behavioral therapy for insomnia (wCBT-I) | Experimental | Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I)The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total) |
| Treatment as usual (TAU) | Other | Behavioral: Treatment as usual (TAU)The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-65 years old
- Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth cognitive behavioral therapy for insomnia (tCBT-I)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 | Behavioural | Telehealth cognitive behavioral therapy for insomnia (tCBT-I) |
| Web-based cognitive behavioral therapy for insomnia (wCBT-I)Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program. | Behavioural | Web-based cognitive behavioral therapy for insomnia (wCBT-I) |
| Treatment as usual (TAU)They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: baseline, Week 6, Week 12
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.
11 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, Week 6, Month 6
Epworth Sleepiness Scale (ESS)
Time frame: baseline, Week 6, Month 6
Dysfunctional Beliefs About Sleep
Time frame: baseline, Week 6, Month 6
Positive Affect and Negative Affect Schedule (PANAS)
Time frame: baseline, Week 6, Month 6
Sleep Self-Efficacy Scale (SESS)
Time frame: baseline, Week 6, Month 6
Actigraphy
Time frame: baseline, Week 6, Month 6
Modified Fatigue Impact Scale (MFIS)
Time frame: baseline, Week 6, Month 6
Fatigue Severity Scale (FSS)
Time frame: 'baseline, Week 6, Month 6
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: baseline, Week 6, Month 6
Cognitive Failures Questionnaire (CFQ)
Time frame: baseline, Week 6, Month 6
plasma neurofilament light (NfL)
Time frame: baseline, Week 6, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telehealth cognitive behavioral therapy for insomnia (tCBT-I), Web-based cognitive behavioral therapy for insomnia (wCBT-I) and Treatment as usual (TAU) 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: looking for participants now, as of the sponsor's last update on 13 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?
Contact Eryen Nelson, MPH (913-945-7349, enelson5@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: baseline, Week 6, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.