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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
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive-Behavioral Therapy, Internet, Telehealth

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 22, 2009
Last Updated
May 25, 2017
Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
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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

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

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