Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

NCT ID: NCT00328250

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-07-31

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.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Cognitive behavioral treatment (CBT) delivered over the Internet

Intervention Type: BEHAVIORAL

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.

2

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

Group Type: ACTIVE_COMPARATOR

Cognitive behavioral treatment (CBT) delivered over the Internet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Lee M Ritterband

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee M. Ritterband, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Locations

University of Virginia Health System, Behavioral Health and Technology

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33057694 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32511726 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19581560 (View on PubMed)

Other Identifiers

R34MH070805

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

12232

Identifier Type: -

Identifier Source: org_study_id