Insomnia
Conditions
Keywords
Multiple Sclerosis
Brief 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.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.
BEHAVIORALControl
Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.
Sponsors
National Multiple Sclerosis Society
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Change from Baseline to Week 7 | 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. |
| Modified Fatigue Impact Scale (MFIS) | Change from Baseline to Week 7 | 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. |
| Fatigue Severity Scale (FSS) | Change from Baseline to Week 7 | 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. |
| Multiple Sclerosis Impact Scale (MSIS) | Change from Baseline to Week 7 | 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. |
Countries
United States
Outcome results
None listed