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Trial record 9 of 50 for:    Internet [ALL-FIELDS] AND NIMH [SPONSOR-COLLABORATORS]

Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lee M Ritterband, University of Virginia
ClinicalTrials.gov Identifier:
NCT00328250
First received: May 17, 2006
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Behavioral: Cognitive behavioral treatment (CBT) delivered over the Internet
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet Insomnia Intervention: Development and Feasibility

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Insomnia Severity Index [ Time Frame: Measured at baseline and Months 3 and 9 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sleep knowledge [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]
  • Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI) [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]
  • Depression as measured by the Beck Depression Inventory 2 [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]
  • Anxiety as measured by the State-Trait Personality Inventory (STPI) [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-benefit measures (direct and indirect costs associated with insomnia) [ Time Frame: Measured at baseline and Months 3 and 9 ] [ Designated as safety issue: No ]
  • Quality of life as measured by the SF-12 Health Survey [ Time Frame: Measured at baseline and Month 3 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328250

Locations
United States, Virginia
University of Virginia Health System, Behavioral Health and Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Lee M. Ritterband, PhD University of Virginia Health System
  More Information

No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee M Ritterband, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT00328250     History of Changes
Other Study ID Numbers: 12232, R34MH070805, DSIR 83-ATAS
Study First Received: May 17, 2006
Last Updated: January 11, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Virginia:
Internet
CBT
Insomnia
Sleep

ClinicalTrials.gov processed this record on November 20, 2014