Skip to main content
Clinical Trials/NCT00821041
NCT00821041
Completed
Phase 2

Evaluation of an Internet-based Treatment for Chronic Insomnia

University of Manitoba1 site in 1 country118 target enrollmentSeptember 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Insomnia
Sponsor
University of Manitoba
Enrollment
118
Locations
1
Primary Endpoint
Sleep Quality
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.

Design This is a randomized controlled trial with online treatment and waiting list control conditions.

Participants

Participants are adults in Manitoba Canada with chronic insomnia.

Setting

Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Nora Vincent

Associate Professor

University of Manitoba

Eligibility Criteria

Inclusion Criteria

  • Access to high speed internet, insomnia duration \> 6 months and occurring at least 4 nights per week, sleep-onset latency \> 30 minutes and/or time awake at night \> 30 minutes, and/or early morning awakening \> 30 minutes before desired time, at least one type of daytime impairment.

Exclusion Criteria

  • Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake \> 14 drinks/week for males, \> 12 drinks per week for females, current or past behavioral treatment for insomnia

Outcomes

Primary Outcomes

Sleep Quality

Time Frame: 6 weeks

Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?" And "How enjoyable was your sleep last night?" (0 = not at all, 4 = very).

Secondary Outcomes

  • Beliefs and Attitudes About Sleep(6 weeks)
  • Pre-Sleep Arousal(6 weeks)

Study Sites (1)

Loading locations...

Similar Trials