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

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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
PICS, Inc.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia Behavioral: Self-help manual to improve insomnia symptoms Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computerized Self-Help Treatment for Primary Insomnia
Study Start Date : January 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Changes in sleep parameters via polysomnography
  2. Changes in sleep parameters via self-reported sleep diary
  3. Changes in symptom severity as measured by Insomnia Severity Index
  4. Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
  5. Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory

Secondary Outcome Measures :
  1. Changes in depression symptoms as measured by Beck Depression Inventory II
  2. Changes in quality of life as measured by a qualitative instrument
  3. Usability of the device as measured by a qualitative questionnaire

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00310284     History of Changes
Other Study ID Numbers: 5R44HL065893 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: March 2006

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