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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44HL065893 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.
Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.
Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized delivery of cognitive-behavioral treatment of insomnia | Behavioral | |||
| Self-help manual to improve insomnia symptoms | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sleep parameters via polysomnography | ||
| Changes in sleep parameters via self-reported sleep diary | ||
| Changes in symptom severity as measured by Insomnia Severity Index | ||
| Changes in symptom severity as measured by Pittsburgh Sleep Quality Index | ||
| Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depression symptoms as measured by Beck Depression Inventory II | ||
| Changes in quality of life as measured by a qualitative instrument | ||
| Usability of the device as measured by a qualitative questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anahi Collado-Rodriguez, B.S. | Contact | 703-766-2849 | acollado@lifesign.com |
| Name | Affiliation | Role |
|---|---|---|
| Bradford W Applegate, Ph.D. | PICS, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PICS, Inc. | Recruiting | Reston | Virginia | 20191 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| D001523 |
| Mental Disorders |