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Completed

NCT Number: NCT01162655

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Centre

Winnipeg, Manitoba, R3E 3N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral therapy for Insomnia (CBT)

Behavioral

6-week course of CBT delivered either using internet or telehealth

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre Foundation, Manitoba

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 14, 2010
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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