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Completed

NCT Number: NCT00328250

Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

This study will evaluate the effectiveness of an online cognitive behavioral therapy intervention in improving sleep, mood, and cognitive functioning in people with insomnia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Virginia Health System, Behavioral Health and Technology

Charlottesville, Virginia, 22903, United States

About this study

Insomnia is a disorder that is characterized by a perception or complaint of inadequate or poor-quality sleep. Symptoms of insomnia include difficulty falling asleep, waking frequently during the night and having difficulty returning to sleep, waking too early in the morning, and unrefreshing sleep. Insomnia may also cause problems during the day, such as tiredness, difficulty concentrating, and irritability. Cognitive behavior therapy (CBT) has been found to have significant short- and long-term benefits for people with insomnia. Access to CBT for many people, however, is limited, due to the high cost of treatment and a lack of trained professionals in some locations. Delivering CBT via the internet could help make the treatment more widely available. This study will evaluate the effectiveness of an online CBT intervention in improving sleep, mood, and cognitive functioning in people with insomnia.

Participants in this open label study will be randomly assigned to receive the online CBT intervention either immediately or after a 4-month waiting period. Participants will use the online program for 1 to 2 hours per week for 8 weeks. Participants will keep track of their sleep patterns for the first and last 2 weeks of a 4-month period by keeping a daily diary and wearing a wrist watch device that monitors movement. All participants will report to the study site for baseline evaluations before beginning treatment and for final evaluations upon completing the program, about 4 months after study entry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjective complaints of poor sleep
  • Difficulties falling and/or staying asleep (sleep onset latency and/or wake after sleep onset is greater than 30 minutes; sleep efficiency is less than 85%)
  • Sleep difficulties at least 3 nights per week
  • Sleep difficulties have persisted for more than 6 months
  • At least one daytime problem due to poor sleep (e.g., fatigue, performance impairment, or mood disturbance)
  • Daytime problems due to sleep disturbances cause marked distress or significant impairment in social or occupational functioning
  • Has internet access

Exclusion criteria

  • Presence of other sleep disorders (as evaluated by specific questions from structured interview) (e.g., sleep apnea, periodic leg movements while sleeping, or parasomnias)
  • Significant psychological distress (including clinical depression and anxiety), as determined using the Beck Depression Inventory (BDI), STPI, Patient Health Questionnaire (PHQ), and clinical interview
  • Substance use or medical condition that causes sleep problems
  • Currently receiving psychological treatment
  • Taking medications that have not been stabilized for the 3 months prior to study entry
  • Regularly goes to sleep after 2am or wakes after 9am
  • Shift worker

Treatment and study plan

Cognitive behavioral treatment (CBT) delivered over the Internet

Behavioral

CBT delivered over the Internet for insomnia targets maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems. Treatment includes through educational, behavioral, and cognitive strategies.

Primary outcomes

  1. Sleep efficiency, total sleep time, total wake time, sleep-onset latency, wake after sleep onset, and early morning awakening

    Time frame: Measured at baseline and Months 3 and 9

  2. Insomnia Severity Index

    Time frame: Measured at baseline and Months 3 and 9

  3. Beliefs and attitudes about sleep as measured by the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS 16)

    Time frame: Measured at baseline and Month 3

  4. Sleep knowledge

    Time frame: Measured at baseline and Month 3

  5. Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI)

    Time frame: Measured at baseline and Month 3

  6. Depression as measured by the Beck Depression Inventory 2

    Time frame: Measured at baseline and Month 3

  7. Anxiety as measured by the State-Trait Personality Inventory (STPI)

    Time frame: Measured at baseline and Month 3

  8. Cognitive functioning as measured by the Headminder's Customized Research Tool (CRT) and Conner's Continuous Performance Test (CPT)

    Time frame: Measured at baseline and Month 3

Secondary outcomes

  1. Cost-benefit measures (direct and indirect costs associated with insomnia)

    Time frame: Measured at baseline and Months 3 and 9

  2. Quality of life as measured by the SF-12 Health Survey

    Time frame: Measured at baseline and Month 3

  3. Feedback regarding use of the internet intervention, including post-treatment ratings of treatment credibility, acceptability, effectiveness, satisfaction, and ease of use of the internet

    Time frame: Measured at Month 3

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Internet Insomnia Intervention: Development and Feasibility

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 19, 2006
Registry last updated
Jan 12, 2012

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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