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Sleep Initiation and Maintenance DisordersPhase 1/2NCT00328250

Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

A Phase 1/2 study testing Cognitive behavioral treatment (CBT) delivered over the Internet in people with Sleep Initiation and Maintenance Disorders, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
What is being tested?
Cognitive behavioral treatment (CBT) delivered over the Internet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Oct 2006to Jul 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia Health System, Behavioral Health and Technology

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Cognitive behavioral treatment (CBT) delivered over the Internet
Keywords
Internet, CBT, Insomnia, Sleep
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioral treatment (CBT) delivered over the InternetBehavioural

    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.

Study groups in NCT00328250
Study groupRoleWhat they receive
1ExperimentalParticipants will receive the online CBT intervention immediately and will use the online program for 8 weeks
Receives: Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet
2Active comparatorParticipants will receive the online CBT intervention after a 4-month waiting period
Receives: Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Measured at baseline and Months 3 and 9

  2. Insomnia Severity Index

    Measured: 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)

    Measured: Measured at baseline and Month 3

  4. Sleep knowledge

    Measured: Measured at baseline and Month 3

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

    Measured: Measured at baseline and Month 3

  6. Depression as measured by the Beck Depression Inventory 2

    Measured: Measured at baseline and Month 3

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

    Measured: 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)

    Measured: Measured at baseline and Month 3

Secondary outcomes (3)

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

    Measured: Measured at baseline and Months 3 and 9

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

    Measured: 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

    Measured: Measured at Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00328250
Sponsor's protocol ID
12232
Other IDs
R34MH070805, DSIR 83-ATAS
Status last verified
Jan 2012
First submitted
17 May 2006
Last updated
12 Jan 2012
Results posted
No
Data monitoring committee
No

Publications

  • Shaffer KM, Finkelstein EA, Camacho F, Ingersoll KS, Thorndike F, Ritterband LM. Effects of an Internet-Based Cognitive Behavioral Therapy for Insomnia Program on Work Productivity: A Secondary Analysis. Ann Behav Med. 2021 Jun 2;55(6):592-599. doi: 10.1093/abm/kaaa085.

    PubMed 33057694

  • Shaffer KM, Hedeker D, Morin CM, Ingersoll K, Thorndike F, Ritterband LM. Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission. Sleep. 2020 Dec 14;43(12):zsaa115. doi: 10.1093/sleep/zsaa115.

    PubMed 32511726

  • Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.

    PubMed 19581560

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cognitive behavioral treatment (CBT) delivered over the Internet in people with Sleep Initiation and Maintenance Disorders, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00328250, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.

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