A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Primary Purpose
Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized delivery of cognitive-behavioral treatment of insomnia
Self-help manual to improve insomnia symptoms
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Sleep
Eligibility 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
Sites / Locations
- PICS, Inc.Recruiting
Outcomes
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
Full Information
NCT ID
NCT00310284
First Posted
March 31, 2006
Last Updated
March 31, 2006
Sponsor
PICS, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00310284
Brief Title
A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Official Title
Computerized Self-Help Treatment for Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
PICS, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Computerized delivery of cognitive-behavioral treatment of insomnia
Intervention Type
Behavioral
Intervention Name(s)
Self-help manual to improve insomnia symptoms
Primary Outcome Measure Information:
Title
Changes in sleep parameters via polysomnography
Title
Changes in sleep parameters via self-reported sleep diary
Title
Changes in symptom severity as measured by Insomnia Severity Index
Title
Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
Title
Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory
Secondary Outcome Measure Information:
Title
Changes in depression symptoms as measured by Beck Depression Inventory II
Title
Changes in quality of life as measured by a qualitative instrument
Title
Usability of the device as measured by a qualitative questionnaire
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anahi Collado-Rodriguez, B.S.
Phone
703-766-2849
Email
acollado@lifesign.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradford W Applegate, Ph.D.
Organizational Affiliation
PICS, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
PICS, Inc.
City
Reston
State/Province
Virginia
ZIP/Postal Code
20191
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anahi Collado-Rodriguez, B.S.
Phone
703-766-2849
Email
acollado@lifesign.com
First Name & Middle Initial & Last Name & Degree
Bradford W. Applegate, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
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