Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

January 11, 2012 updated by: Lee M Ritterband, University of Virginia

Internet Insomnia Intervention: Development and Feasibility

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System, Behavioral Health and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Participants will receive the online CBT intervention immediately and will use the online program for 8 weeks
Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet
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.
ACTIVE_COMPARATOR: 2
Participants will receive the online CBT intervention after a 4-month waiting period
Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at baseline and Months 3 and 9
Insomnia Severity Index
Time Frame: Measured at baseline and Months 3 and 9
Measured at baseline and Months 3 and 9
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
Measured at baseline and Month 3
Sleep knowledge
Time Frame: Measured at baseline and Month 3
Measured at baseline and Month 3
Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI)
Time Frame: Measured at baseline and Month 3
Measured at baseline and Month 3
Depression as measured by the Beck Depression Inventory 2
Time Frame: Measured at baseline and Month 3
Measured at baseline and Month 3
Anxiety as measured by the State-Trait Personality Inventory (STPI)
Time Frame: Measured at baseline and Month 3
Measured at baseline and Month 3
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
Measured at baseline and Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost-benefit measures (direct and indirect costs associated with insomnia)
Time Frame: Measured at baseline and Months 3 and 9
Measured at baseline and Months 3 and 9
Quality of life as measured by the SF-12 Health Survey
Time Frame: Measured at baseline and Month 3
Measured at baseline and Month 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
Measured at Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Lee M. Ritterband, PhD, University of Virginia Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (ESTIMATE)

May 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12232 (Other Identifier: Company Internal)
  • DSIR 83-ATAS (NIMH Program Class Code)
  • R34MH070805 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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