Recruiting

Insomnia Treatments

Sponsor:

PICS, Inc.

Code:

NCT00310284

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Computerized delivery of cognitive-behavioral treatment of insomnia

Self-help manual to improve insomnia symptoms

Study Details

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.

Conditions

Insomnia

Study ID

NCT00310284

Start date

Jan, 2006

Status verified date

Mar, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Computerized delivery of cognitive-behavioral treatment of insomnia

Self-help manual to improve insomnia symptoms

Primary outcome measure

  • Changes in sleep parameters via polysomnography [ Time Frame: undefined ]
  • Changes in sleep parameters via self-reported sleep diary [ Time Frame: undefined ]
  • Changes in symptom severity as measured by Insomnia Severity Index [ Time Frame: undefined ]
  • Changes in symptom severity as measured by Pittsburgh Sleep Quality Index [ Time Frame: undefined ]
  • Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Anahi Collado-Rodriguez, B.S.

703-766-2849acollado@lifesign.com

Locations

PICS, Inc.

Recruiting

Reston, Virginia, United States, 20191

Contacts

Anahi Collado-Rodriguez, B.S.

703-766-2849acollado@lifesign.com

Principal Investigator:

Bradford W. Applegate, Ph.D.

More Information

Sponsor

PICS, Inc.

Last update posted

Apr 3, 2006

Last verified

Mar, 2006

Keywords

  • Insomnia
  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PICS, Inc. on 2006-04-03.