A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00310284|
Recruitment Status : Unknown
Verified March 2006 by PICS, Inc..
Recruitment status was: Recruiting
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
|Condition or disease||Intervention/treatment|
|Insomnia||Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia Behavioral: Self-help manual to improve insomnia symptoms|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Computerized Self-Help Treatment for Primary Insomnia|
|Study Start Date :||January 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310284
|Contact: Anahi Collado-Rodriguez, B.S.||firstname.lastname@example.org|
|United States, Virginia|
|Reston, Virginia, United States, 20191|
|Contact: Anahi Collado-Rodriguez, B.S. 703-766-2849 email@example.com|
|Principal Investigator: Bradford W. Applegate, Ph.D.|
|Principal Investigator:||Bradford W Applegate, Ph.D.||PICS, Inc.|