A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.

Not Applicable

• Conditions: Insomnia

• Registration Number: NCT00310284
• Lead Sponsor: PICS, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2006-01
• Status Verified: 2006-03
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Last Update Submitted: 2006-03-31
• Study First Posted: 2006-04-03
• Last Update Posted: 2006-04-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

PICS, Inc.; 🇺🇸 Reston, Virginia, United States