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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 because the information has not been verified recently.
Verified March 2006 by PICS, Inc..
Recruitment status was  Recruiting
Sponsor:
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 
Study First Received: March 31, 2006
Last Updated: March 31, 2006
Health Authority: United States: Institutional Review Board

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 29, 2016