Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications

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..

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI); Behavioral: Class in sleeping well and improving insomnia

• Study Type: Interventional
• Enrollment (Actual): 136630
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91101
      • Kaiser Permanente Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Contained in inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iCBTI; 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); An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.
ACTIVE_COMPARATOR: Usual care; Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.	Behavioral: Class in sleeping well and improving insomnia; A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days supply of dispensed insomnia medications	Days supply of dispensed insomnia medications up to one year after randomization.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health care inpatient and outpatient encounters	Number of physician or mid-level provider encounters (face-to-face, telephone, video): (1) outpatient, (2) acute care: emergency, inpatient, up to one year after randomization.	One year

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Big Health Inc.
• Investigators: Principal Investigator: Stephen Derose, MD, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2018
• Primary Completion (ACTUAL): June 19, 2018
• Study Completion (ACTUAL): June 19, 2019

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (ACTUAL): October 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 11262 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No