search
Back to results

Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

Primary Purpose

Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral treatment (CBT) delivered over the Internet
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Internet, CBT, Insomnia, Sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Virginia Health System, Behavioral Health and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive the online CBT intervention immediately and will use the online program for 8 weeks

Participants will receive the online CBT intervention after a 4-month waiting period

Outcomes

Primary Outcome Measures

Sleep efficiency, total sleep time, total wake time, sleep-onset latency, wake after sleep onset, and early morning awakening
Insomnia Severity Index
Beliefs and attitudes about sleep as measured by the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS 16)
Sleep knowledge
Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI)
Depression as measured by the Beck Depression Inventory 2
Anxiety as measured by the State-Trait Personality Inventory (STPI)
Cognitive functioning as measured by the Headminder's Customized Research Tool (CRT) and Conner's Continuous Performance Test (CPT)

Secondary Outcome Measures

Cost-benefit measures (direct and indirect costs associated with insomnia)
Quality of life as measured by the SF-12 Health Survey
Feedback regarding use of the internet intervention, including post-treatment ratings of treatment credibility, acceptability, effectiveness, satisfaction, and ease of use of the internet

Full Information

First Posted
May 17, 2006
Last Updated
January 11, 2012
Sponsor
University of Virginia
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00328250
Brief Title
Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia
Official Title
Internet Insomnia Intervention: Development and Feasibility
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Internet, CBT, Insomnia, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the online CBT intervention immediately and will use the online program for 8 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive the online CBT intervention after a 4-month waiting period
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral treatment (CBT) delivered over the Internet
Intervention Description
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 Outcome Measure Information:
Title
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
Title
Insomnia Severity Index
Time Frame
Measured at baseline and Months 3 and 9
Title
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
Title
Sleep knowledge
Time Frame
Measured at baseline and Month 3
Title
Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI)
Time Frame
Measured at baseline and Month 3
Title
Depression as measured by the Beck Depression Inventory 2
Time Frame
Measured at baseline and Month 3
Title
Anxiety as measured by the State-Trait Personality Inventory (STPI)
Time Frame
Measured at baseline and Month 3
Title
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 Outcome Measure Information:
Title
Cost-benefit measures (direct and indirect costs associated with insomnia)
Time Frame
Measured at baseline and Months 3 and 9
Title
Quality of life as measured by the SF-12 Health Survey
Time Frame
Measured at baseline and Month 3
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee M. Ritterband, PhD
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System, Behavioral Health and Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33057694
Citation
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.
Results Reference
derived
PubMed Identifier
32511726
Citation
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.
Results Reference
derived
PubMed Identifier
19581560
Citation
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. Erratum In: Arch Gen Psychiatry. 2010 Mar;67(3):311.
Results Reference
derived

Learn more about this trial

Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

We'll reach out to this number within 24 hrs