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

Insomnia Clinical Trial

Official title:

Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162655
• Other study ID #: H2009:110
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: May 25, 2017
• Start date: April 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive-behavioral therapy for Insomnia (CBT)
6-week course of CBT delivered either using internet or telehealth

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks
Secondary	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.	6 weeks