Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-behavioral therapy for Insomnia (CBT)
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive-Behavioral Therapy, Internet, Telehealth
Eligibility Criteria
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
Sites / Locations
- Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Telehealth
Internet
Arm Description
Complete CBT group via telehealth
Complete Internet-based CBT program
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Sleep diary data
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.
Full Information
NCT ID
NCT01162655
First Posted
December 22, 2009
Last Updated
May 25, 2017
Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT01162655
Brief Title
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
Official Title
Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Cognitive-Behavioral Therapy, Internet, Telehealth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telehealth
Arm Type
Experimental
Arm Description
Complete CBT group via telehealth
Arm Title
Internet
Arm Type
Experimental
Arm Description
Complete Internet-based CBT program
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy for Insomnia (CBT)
Intervention Description
6-week course of CBT delivered either using internet or telehealth
Primary Outcome Measure Information:
Title
Insomnia Severity
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Sleep diary data
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maxine Holmqvist, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3N4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24461370
Citation
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.
Results Reference
background
Learn more about this trial
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
We'll reach out to this number within 24 hrs