Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMay 30, 2017
May 1, 2017
3.2 years
December 22, 2009
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity
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
6 weeks
Secondary Outcomes (1)
Sleep diary data
6 weeks
Study Arms (2)
Telehealth
EXPERIMENTALComplete CBT group via telehealth
Internet
EXPERIMENTALComplete Internet-based CBT program
Interventions
6-week course of CBT delivered either using internet or telehealth
Eligibility Criteria
You may qualify if:
- Must be residents of rural Manitoba (Canada)
- Must meet research diagnostic criteria for insomnia
- Must have access to a computer and high-speed internet
You may not qualify if:
- Comorbid conditions (medical and psychiatric) must be stable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Sciences Centre
Winnipeg, Manitoba, R3E 3N4, Canada
Related Publications (1)
Holmqvist M, Vincent N, Walsh K. Web- vs. telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014 Feb;15(2):187-95. doi: 10.1016/j.sleep.2013.10.013. Epub 2013 Dec 31.
PMID: 24461370BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maxine Holmqvist, PhD
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychologist & Assistant Professor
Study Record Dates
First Submitted
December 22, 2009
First Posted
July 14, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
May 30, 2017
Record last verified: 2017-05