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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | 6 weeks of CBT-I. |
|
| Control | Active Comparator | 6 weeks of stretching and thinking games. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Week 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Week 7 |
| Modified Fatigue Impact Scale (MFIS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Siengsukon, PT, PhD | University of Kansas Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Control | Behavioral | Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games. |
|
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. |
| 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. | 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. | Change from Baseline to Week 7 |
| D001523 |
| Mental Disorders |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |