Multiple SclerosisNCT04147052
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
A study testing iSLEEPms in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- iSLEEPms
- 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
- 3 Sep 2021to 20 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 and older
- MS diagnosis56 of at least 1 year duration
- Able to speak and read English
- Sleep disturbance as indicated by an ISI score of at least 11
- Willingness to commit to a 4-week intervention and 12-week follow-up assessment
Who cannot join
- Neurological disorder other than MS
- Hazardous alcohol use, as indicated by the Alcohol Use Disorders Identification Test (AUDIT-C)
- Hazardous substance use, as indicated by the Drug Abuse Screening Test (DAST-10)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21211
About this study
Official title: An Internet-delivered Cognitive Behavioral Intervention for Sleep Disturbance in Multiple Sclerosis
Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line insomnia treatment for adults in the general population. Although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. However, more work is needed to understand the effects of internet-delivered CBT-I on patient-reported and objective outcomes.
This study is a pilot randomized controlled trial to test the preliminary effects of iSLEEPms, a CBT-I-based online intervention with telephone support for individuals with MS. After completing a baseline assessment (Week 1), 90 participants with MS will be randomized (1:1) to four weeks (Weeks 2-5) of iSLEEPms (intervention group) or treatment as usual (TAU; control group), and complete post-treatment (Week 6) and follow-up (Week 12) assessments. iSLEEPms participants will complete daily sleep diary forms and weekly online educational modules. TAU participants will continue usual care without access to the iSLEEPms materials.
The primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. Secondary outcomes will be treatment satisfaction, adherence, and integrity (iSLEEPms group only). Exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.
- Conditions
- Multiple Sclerosis
- Being tested
- iSLEEPms
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSLEEPmsBehavioural
Participants randomized to iSLEEPms complete daily online sleep diary forms and weekly online educational modules. Modules focus on typical elements of CBT-I, adapted for individuals with MS: education about sleep in MS, sleep restriction, and stimulus control; sleep hygiene and relaxation; and cognitive restructuring around sleep and coping with MS. Sleep diaries are scored each week, and feedback is provided to participants to guide adjustments to their recommended bedtimes and wake times. Telephone support is available to provide clarification around module content.
| Study group | Role | What they receive |
|---|---|---|
| iSLEEPms | Experimental | Participants randomized to iSLEEPms complete a 4-week online program with telephone support, based on CBT-I. Receives: Behavioral: iSLEEPms |
| Treatment As Usual | No intervention | Participants randomized to TAU continue their usual care and are encouraged to avoid starting any new sleep treatment unless deemed necessary by a health care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Pittsburgh Sleep Quality Index (PSQI) total score
The PSQI is a 9-item participant-reported measure that assesses sleep quality. Scores range from 0 to 21 points, with higher scores indicating poorer sleep quality. Scores ≥ 5 are clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the Insomnia Severity Index (ISI) total score
The ISI is a 7-item participant-reported measure that assesses insomnia symptoms. Scores range from 0 to 28 points (each item is rated 0-4), with higher scores indicating greater insomnia. Scores ≥ 11 are clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in actigraphic total sleep time (TST)
Wrist actigraphy devices objectively assess TST, in minutes. TSTs < 360 min are considered clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in actigraphic sleep efficiency (SE)
Wrist actigraphy devices objectively assess SE as a % of time asleep while in bed. SEs < 85% are considered clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in actigraphic sleep latency (SL)
Wrist actigraphy devices objectively assess SL, in minutes. SLs > 30 min are considered clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in actigraphic wake after sleep onset (WASO)
Wrist actigraphy devices objectively assess WASO, in minutes. WASOs > 30 min are considered clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Secondary outcomes (10)
Change in the Modified Fatigue Impact Scale (MFIS) total score
The MFIS is a 21-item participant-reported measure that assesses how much fatigue impacts physical, cognitive, and psychosocial functioning. Scores range from 0 to 84 (each item is rated 0-4), with higher scores indicating a greater impact of fatigue. Scores ≥ 38 are clinically significant. The scale has three subscales (Physical, 9 items; Cognitive, 10 items; and Psychosocial, 2 items).
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the Beck Depression Inventory - Fast Screen (BDI-FS) total score
The BDI-FS is a 7-item participant-reported measure of depressive symptom severity. Scores range from 0 to 21 (each item rated 0-3), with higher scores indicating greater depressive symptom severity. Scores ≥ 4 are clinically significant.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the MS Neuropsychological Screening Questionnaire (MSNQ) total score
The MSNQ is a 15-item participant-reported measure of subjective cognitive dysfunction. Scores range from 0 to 60 (each item rated 0-4), with higher scores indicating greater perceived cognitive dysfunction.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Memorizing Words (MW) score
TestMyBrain.org is an online platform that objectively assesses cognitive dysfunction. MW is a verbal paired associates test. Participants learn and memorize 25 word pairs and are asked to recall them after a delay. Higher scores indicate better verbal memory performance.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Memorizing Pictures (MP) score
TestMyBrain.org is an online platform that objectively assesses cognitive dysfunction. MP is a visual paired associates test. Participants learn and memorize 24 pictures pairs and are asked to recall them after a delay. Higher scores indicate better visual memory performance.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Matching Shapes and Numbers (MSN) score
TestMyBrain.org is an online platform that objectively assesses cognitive dysfunction. MSN is a speeded digit-symbol coding task. Participants use a key provided on the screen to quickly match 9 unique symbols with their correctly paired digits as quickly as possible. Higher scores indicate faster processing speed.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Fast Choices (FC) score
TestMyBrain.org is an online platform that objectively assesses cognitive dysfunction. FC is a choice reaction time test. Participants view arrows and quickly judge their direction. Higher scores indicate faster processing speed.
Measured: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Treatment Satisfaction Scale (TSS) total score (iSLEEPms group only)
The TSS a 7-item participant-reported measure adapted from the Consumer Report Treatment Satisfaction Scale to assess satisfaction with iSLEEPms. The 7 items (each item rated 1 to 5) are averaged to calculate a total score, with higher scores indicating greater symptom improvement during the iSLEEPms program.
Measured: Post-intervention (Week 6)
iSLEEPms treatment adherence (iSLEEPMS group only)
Treatment adherence will be assessed based on completion of each of the four weekly iSLEEPms modules, including completion of the online daily sleep diary form and weekly module. A total score will be determined based on the percentage of diary forms and weekly modules completed over four weeks.
Measured: Post-intervention (Week 6)
iSLEEPms treatment integrity (iSLEEPMS group only)
Treatment integrity will be assessed based on coverage of coverage of 17 CBT-I elements, adapted from the Treatment Components Adherence Scale. A total score will be determined based on the percentage of elements covered over the four-week iSLEEPms intervention.
Measured: Post-intervention (Weeks 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start3 Sep 2021
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
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 Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Abbey J Hughes, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147052
- Sponsor's protocol ID
- IRB00116581
- Other IDs
- K23HD086154
- Status last verified
- May 2022
- First submitted
- 25 Oct 2019
- Last updated
- 9 May 2022
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-delivered Cognitive Behavioral Intervention for Sleep Disturbance in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04147052
- Acronym / sponsor ID
- IRB00116581
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 31 Oct 2019 (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.
Sleep disturbance, especially insomnia (i.e., difficulty initiating and maintaining sleep), affects over half of people with MS. Cognitive behavioral strategies have been shown to improve sleep quantity and quality in several neurologic populations (e.g., traumatic brain injury, Parkinson's disease), and cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line insomnia treatment for adults in the general population. Although cognitive behavioral interventions have historically been delivered in-person, a growing body of literature supports telephone- and internet-delivered approaches. However, more work is needed to understand the effects of internet-delivered CBT-I on patient-reported and objective outcomes.
This study is a pilot randomized controlled trial to test the preliminary effects of iSLEEPms, a CBT-I-based online intervention with telephone support for individuals with MS. After completing a baseline assessment (Week 1), 90 participants with MS will be randomized (1:1) to four weeks (Weeks 2-5) of iSLEEPms (intervention group) or treatment as usual (TAU; control group), and complete post-treatment (Week 6) and follow-up (Week 12) assessments. iSLEEPms participants will complete daily sleep diary forms and weekly online educational modules. TAU participants will continue usual care without access to the iSLEEPms materials.
The primary outcomes will be patient-reported and actigraphic measures of sleep quality and quantity. Secondary outcomes will be treatment satisfaction, adherence, and integrity (iSLEEPms group only). Exploratory outcomes will be fatigue symptoms, depression symptoms, and cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iSLEEPms | Experimental | Behavioral: iSLEEPmsParticipants randomized to iSLEEPms complete a 4-week online program with telephone support, based on CBT-I. |
| Treatment As Usual | No intervention | –Participants randomized to TAU continue their usual care and are encouraged to avoid starting any new sleep treatment unless deemed necessary by a health care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18 and older
- MS diagnosis56 of at least 1 year duration
- Able to speak and read English
- Sleep disturbance as indicated by an ISI score of at least 11
- Willingness to commit to a 4-week intervention and 12-week follow-up assessment
Key exclusion criteria (3 listed)
- Neurological disorder other than MS
- Hazardous alcohol use, as indicated by the Alcohol Use Disorders Identification Test (AUDIT-C)
- Hazardous substance use, as indicated by the Drug Abuse Screening Test (DAST-10)
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 |
|---|---|---|
| iSLEEPmsParticipants randomized to iSLEEPms complete daily online sleep diary forms and weekly online educational modules. Modules focus on typical elements of CBT-I, adapted for individuals with MS: education about sleep in MS, sleep restriction, and stimulus control; sleep hygiene and relaxation; and cognitive restructuring around sleep and coping with MS. Sleep diaries are scored each week, and feedback is provided to participants to guide adjustments to their recommended bedtimes and wake times. Telephone support is available to provide clarification around module content. | Behavioural | iSLEEPms |
Primary outcome
Change in the Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
The PSQI is a 9-item participant-reported measure that assesses sleep quality. Scores range from 0 to 21 points, with higher scores indicating poorer sleep quality. Scores ≥ 5 are clinically significant.
Change in the Insomnia Severity Index (ISI) total score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
The ISI is a 7-item participant-reported measure that assesses insomnia symptoms. Scores range from 0 to 28 points (each item is rated 0-4), with higher scores indicating greater insomnia. Scores ≥ 11 are clinically significant.
Change in actigraphic total sleep time (TST)
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess TST, in minutes. TSTs < 360 min are considered clinically significant.
Change in actigraphic sleep efficiency (SE)
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess SE as a % of time asleep while in bed. SEs < 85% are considered clinically significant.
Change in actigraphic sleep latency (SL)
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess SL, in minutes. SLs > 30 min are considered clinically significant.
Change in actigraphic wake after sleep onset (WASO)
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Wrist actigraphy devices objectively assess WASO, in minutes. WASOs > 30 min are considered clinically significant.
10 secondary outcomes
Change in the Modified Fatigue Impact Scale (MFIS) total score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the Beck Depression Inventory - Fast Screen (BDI-FS) total score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the MS Neuropsychological Screening Questionnaire (MSNQ) total score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Memorizing Words (MW) score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Memorizing Pictures (MP) score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Matching Shapes and Numbers (MSN) score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Change in the TestMyBrain Fast Choices (FC) score
Time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)
Treatment Satisfaction Scale (TSS) total score (iSLEEPms group only)
Time frame: Post-intervention (Week 6)
iSLEEPms treatment adherence (iSLEEPMS group only)
Time frame: Post-intervention (Week 6)
iSLEEPms treatment integrity (iSLEEPMS group only)
Time frame: Post-intervention (Weeks 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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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. This study is not recruiting at the moment.
Abbey J Hughes principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSLEEPms in people with Multiple Sclerosis, run by Johns Hopkins University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 9 May 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the Pittsburgh Sleep Quality Index (PSQI) total score (time frame: Baseline (Week 1), Post-intervention (Week 6), and Follow-up (Week 12)). The study lists 6 primary outcomes in all. 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 9 May 2022.