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Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth

This study has been completed.
Sponsor:
Collaborator:
Health Sciences Centre Foundation, Manitoba
Information provided by (Responsible Party):
Dr. Maxime Holmqvist, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01162655
First received: December 22, 2009
Last updated: July 29, 2013
Last verified: July 2013

December 22, 2009
July 29, 2013
April 2010
June 2013   (final data collection date for primary outcome measure)
Insomnia Severity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01162655 on ClinicalTrials.gov Archive Site
Sleep diary data [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Sleep diaries are a standard daily outcome measure for insomnia. The version used here (Morin, 1993) includes information regarding total sleep time, sleep-onset latency, sleep-efficiency, number of night awakenings, time awake in then night, sleep quality, and frequency of use of sleep medications.
Same as current
Not Provided
Not Provided
 
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)
6-week course of CBT delivered either using internet or telehealth
  • Experimental: Telehealth
    Complete CBT group via telehealth
    Intervention: Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)
  • Experimental: Internet
    Complete Internet-based CBT program
    Intervention: Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01162655
H2009:110
Yes
Dr. Maxime Holmqvist, University of Manitoba
University of Manitoba
Health Sciences Centre Foundation, Manitoba
Principal Investigator: Maxine Holmqvist, PhD University of Manitoba
University of Manitoba
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP