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A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by PICS, Inc..
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
PICS, Inc.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
PICS, Inc.
ClinicalTrials.gov Identifier:
NCT00310284
First received: March 31, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
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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 Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Computerized Self-Help Treatment for Primary Insomnia |
Further study details as provided by PICS, Inc.:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310284
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310284
Contacts
| Contact: Anahi Collado-Rodriguez, B.S. | 703-766-2849 | acollado@lifesign.com |
Locations
| 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. | |
Sponsors and Collaborators
PICS, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Bradford W Applegate, Ph.D. | PICS, Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00310284 History of Changes |
| Other Study ID Numbers: |
5R44HL065893 ( U.S. NIH Grant/Contract ) |
| Study First Received: | March 31, 2006 |
| Last Updated: | March 31, 2006 |
Keywords provided by PICS, Inc.:
|
Insomnia Sleep |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on September 25, 2017