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

Insomnia Clinical Trial

Official title:

Computerized Self-Help Treatment for Primary Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00310284
• Other study ID #: 5R44HL065893
• Secondary ID: 5R44HL065893
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2006
• Last updated: March 31, 2006
• Start date: January 2006

Study information

• Verified date: March 2006
• Source: PICS, Inc.
• Contact: Anahi Collado-Rodriguez, B.S.
• Phone: 703-766-2849
• Email: acollado[@]lifesign.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Computerized delivery of cognitive-behavioral treatment of insomnia

• Self-help manual to improve insomnia symptoms

Locations

Country	Name	City	State
United States	PICS, Inc.	Reston	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
PICS, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in sleep parameters via polysomnography
Primary	Changes in sleep parameters via self-reported sleep diary
Primary	Changes in symptom severity as measured by Insomnia Severity Index
Primary	Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
Primary	Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory
Secondary	Changes in depression symptoms as measured by Beck Depression Inventory II
Secondary	Changes in quality of life as measured by a qualitative instrument
Secondary	Usability of the device as measured by a qualitative questionnaire