Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

NCT03313466 | Completed

• 1 other identifier: 11262
• Study Type: interventional
• Target: 136,630
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Days supply of dispensed insomnia medications

  Days supply of dispensed insomnia medications up to one year after randomization.

  One year

Secondary Outcomes (1)

• Health care inpatient and outpatient encounters

  One year

Study Arms (2)

iCBTI

EXPERIMENTAL

Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions.

Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI)

Usual care

ACTIVE COMPARATOR

Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.

Behavioral: Class in sleeping well and improving insomnia

Interventions

Internet cognitive behavioral therapy for insomnia (iCBTI) BEHAVIORAL

An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.

iCBTI

Class in sleeping well and improving insomnia BEHAVIORAL

A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

Usual care

Eligibility Criteria

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

You may qualify if:

• A prescription for any of a set of selected insomnia medications.
• Age \>18 years at the time of the prescription.
• A recent (\<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
• Membership for \>365 days prior to the prescription date.
• No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Big Health Inc.: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Related Publications (1)

• Derose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021 Aug 1;17(8):1675-1684. doi: 10.5664/jcsm.9280.

  PMID: 33908343 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Artifacts

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Stephen Derose, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 18, 2017
• Study Start: March 13, 2018
• Primary Completion: June 19, 2018
• Study Completion: June 19, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)