A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Recruitment status was Recruiting
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.
Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia
Behavioral: Self-help manual to improve insomnia symptoms
|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
|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.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|