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
  Purpose

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 Intervention
Insomnia
Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 110
Study Start Date: April 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 22, 2009
Last Updated: July 29, 2013
Health Authority: CANADA: University of Manitoba Research Ethics Board

Keywords provided by University of Manitoba:
Insomnia
Cognitive-Behavioral Therapy
Internet
Telehealth

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

ClinicalTrials.gov processed this record on July 26, 2014