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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:
Information provided by:

March 31, 2006
April 3, 2006
April 3, 2006
January 2006
Not Provided
  • 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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Computerized Self-Help Treatment for Primary Insomnia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Insomnia
  • Behavioral: Computerized delivery of cognitive-behavioral treatment of insomnia
  • Behavioral: Self-help manual to improve insomnia symptoms
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00310284
5R44HL065893( U.S. NIH Grant/Contract )
5R44HL065893 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Not Provided
PICS, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bradford W Applegate, Ph.D. PICS, Inc.
PICS, Inc.
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP