Insomnia
Conditions
Keywords
Insomnia, Sleep
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.
Interventions
BEHAVIORALComputerized delivery of cognitive-behavioral treatment of insomnia
BEHAVIORALSelf-help manual to improve insomnia symptoms
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
PICS, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory | — |
| 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 sleep parameters via polysomnography | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in quality of life as measured by a qualitative instrument | — |
| Usability of the device as measured by a qualitative questionnaire | — |
| Changes in depression symptoms as measured by Beck Depression Inventory II | — |
Countries
United States
Contacts
Primary ContactAnahi Collado-Rodriguez, B.S.
Outcome results
None listed