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Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

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University of Virginia

Status and phase

Completed
Phase 2
Phase 1

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00328250
DSIR 83-ATAS
12232
R34MH070805 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

1
Experimental group
Description:
Participants will receive the online CBT intervention immediately and will use the online program for 8 weeks
Treatment:
Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet
2
Active Comparator group
Description:
Participants will receive the online CBT intervention after a 4-month waiting period
Treatment:
Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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