NCT00310284

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
Last Updated

April 3, 2006

Status Verified

March 1, 2006

First QC Date

March 31, 2006

Last Update Submit

March 31, 2006

Conditions

Insomnia

Keywords

InsomniaSleep

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • 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

Interventions

Computerized delivery of cognitive-behavioral treatment of insomniaBEHAVIORAL
Self-help manual to improve insomnia symptomsBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PICS, Inc.

Reston, Virginia, 20191, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Bradford W Applegate, Ph.D.

    PICS, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahi Collado-Rodriguez, B.S.

CONTACT

703-766-2849acollado@lifesign.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 3, 2006

Study Start

January 1, 2006

Last Updated

April 3, 2006

Record last verified: 2006-03

Locations

US(1)