We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01162655
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Insomnia Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet
Study Start Date : April 2010
Primary Completion Date : June 2013
Study Completion Date : June 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Telehealth
Complete CBT group via telehealth
Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)
6-week course of CBT delivered either using internet or telehealth
Experimental: Internet
Complete Internet-based CBT program
Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)
6-week course of CBT delivered either using internet or telehealth


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Sleep diary data [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162655


Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E 3N4
Sponsors and Collaborators
University of Manitoba
Health Sciences Centre Foundation, Manitoba
Investigators
Principal Investigator: Maxine Holmqvist, PhD University of Manitoba
More Information

Publications:
Responsible Party: Dr. Maxime Holmqvist, Clinical Psychologist & Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01162655     History of Changes
Other Study ID Numbers: H2009:110
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Dr. Maxime Holmqvist, University of Manitoba:
Insomnia
Cognitive-Behavioral Therapy
Internet
Telehealth

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders