A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Insomnia |
Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia Behavioral: Self-help manual to improve insomnia symptoms |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Computerized Self-Help Treatment for Primary Insomnia |
- 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
- 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
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- sleep less than 6.5 hours per night
- at least 30 minutes of sleep onset latency or wakefulness after sleep onset
- symptoms present for at least 6 months
- must have insomnia symptoms at least 3 days per week
Exclusion Criteria:
- Body Mass Index greater than 32
- Presence of anxiety disorder
- Secondary forms of insomnia
- Presence of a substance use disorder
- Concurrent treatment for another mental disorder
- History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy
Contacts and Locations| Contact: Anahi Collado-Rodriguez, B.S. | 703-766-2849 | acollado@lifesign.com |
| United States, Virginia | |
| PICS, Inc. | Recruiting |
| Reston, Virginia, United States, 20191 | |
| Contact: Anahi Collado-Rodriguez, B.S. 703-766-2849 acollado@lifesign.com | |
| Principal Investigator: Bradford W. Applegate, Ph.D. | |
| Principal Investigator: | Bradford W Applegate, Ph.D. | PICS, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00310284 History of Changes |
| Other Study ID Numbers: | 5-R44-HL-65893, 5-R44-HL-65893 |
| Study First Received: | March 31, 2006 |
| Last Updated: | March 31, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by PICS, Inc.:
|
Insomnia Sleep |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013