InsomniaNCT03216889
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
A study testing Cognitive Behavioral Therapy for Insomnia in people with Insomnia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2017to 15 Aug 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS by physician
- Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
- ≥10 on Insomnia Severity Index
- English speaking
- Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia
Who cannot join
- Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- >4 on STOP BANG indicating high risk of sleep apnea
- Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
- Nervous system disorder other than MS
- Relapse and/or corticosteroid use in past 8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Control
- Keywords
- Multiple Sclerosis
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.
ControlBehavioural
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | 6 weeks of CBT-I. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Control | Active comparator | 6 weeks of stretching and thinking games. Receives: Behavioral: Control |
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: Change from Baseline to Week 7
Secondary outcomes (4)
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: Change from Baseline to Week 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: Change from Baseline to Week 7
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: Change from Baseline to Week 7
Multiple Sclerosis Impact Scale (MSIS)
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: Change from Baseline to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start29 Jun 2017
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Katie Siengsukon, PT, PhD, Study chair, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216889
- Sponsor's protocol ID
- STUDY00140418
- Status last verified
- Aug 2019
- First submitted
- 11 Jul 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03216889
- Acronym / sponsor ID
- STUDY00140418
- Conditions
- Insomnia
- Keywords
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 13 Jul 2017 (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 purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia6 weeks of CBT-I. |
| Control | Active comparator | Behavioral: Control6 weeks of stretching and thinking games. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of MS by physician
- Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
- ≥10 on Insomnia Severity Index
- English speaking
- Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia
Key exclusion criteria (5 listed)
- Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
- >4 on STOP BANG indicating high risk of sleep apnea
- Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
- Nervous system disorder other than MS
- Relapse and/or corticosteroid use in past 8 weeks
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 |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaInvolves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group. | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| ControlInvolves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games. | Behavioural | Control |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change from Baseline to Week 7
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.
4 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from Baseline to Week 7
Modified Fatigue Impact Scale (MFIS)
Time frame: Change from Baseline to Week 7
Fatigue Severity Scale (FSS)
Time frame: Change from Baseline to Week 7
Multiple Sclerosis Impact Scale (MSIS)
Time frame: Change from Baseline to Week 7
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 28 Aug 2019.
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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.
Katie Siengsukon, PT, PhD study chair
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with 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 5 inclusion and 5 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 28 Aug 2019. 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?
Insomnia Severity Index (ISI) (time frame: Change from Baseline to Week 7). 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 28 Aug 2019.