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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:
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

March 31, 2006
March 31, 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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years to 75 Years
Yes
Contact: Anahi Collado-Rodriguez, B.S. 703-766-2849 acollado@lifesign.com
United States
 
NCT00310284
5-R44-HL-65893, 5-R44-HL-65893
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