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Clinical Trials/NCT01162655
NCT01162655CompletedNot Applicable

Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet

University of Manitoba2 sites in 1 country110 target enrollmentStarted: April 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
2
Primary Endpoint
Insomnia Severity

Study Overview

Brief Summary

Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Must be residents of rural Manitoba (Canada)
  • Must meet research diagnostic criteria for insomnia
  • Must have access to a computer and high-speed internet

Exclusion Criteria

  • Comorbid conditions (medical and psychiatric) must be stable

Outcomes

Primary Outcomes

Insomnia Severity

Time Frame: 6 weeks

The primary outcome measure will be insomnia severity, as assessed by the Insomnia Severity Index (ISI; Morin, 2003), a 6-item self-report measure of impairment due to sleep difficulties

Secondary Outcomes

  • Sleep diary data(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Maxime Holmqvist

Clinical Psychologist & Assistant Professor

University of Manitoba

Study Sites (2)

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