Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia

NCT00328250 | Completed Phase 1

• 3 other identifiers: 12232R34MH070805DSIR 83-ATAS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Internet; CBT; Insomnia; Sleep

Outcome Measures

Primary Outcomes (8)

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

  Measured at baseline and Months 3 and 9

• Insomnia Severity Index

  Measured at baseline and Months 3 and 9

• Beliefs and attitudes about sleep as measured by the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS 16)

  Measured at baseline and Month 3

• Sleep knowledge

  Measured at baseline and Month 3

• Fatigue as measured by the Multidimensional Fatigue Symptom Inventory (MFSI)

  Measured at baseline and Month 3

• Depression as measured by the Beck Depression Inventory 2

  Measured at baseline and Month 3

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

  Measured at baseline and Month 3

• Cognitive functioning as measured by the Headminder's Customized Research Tool (CRT) and Conner's Continuous Performance Test (CPT)

  Measured at baseline and Month 3

Secondary Outcomes (3)

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

  Measured at baseline and Months 3 and 9

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

  Measured at baseline and Month 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 at Month 3

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

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

Interventions

Cognitive behavioral treatment (CBT) delivered over the Internet 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.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Virginia Health System, Behavioral Health and Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (3)

• 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.

  PMID: 33057694 DERIVED

• 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.

  PMID: 32511726 DERIVED

• 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.

  PMID: 19581560 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Lee M. Ritterband, PhD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 19, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

US (1)