Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI); Behavioral: Class in sleeping well and improving insomnia

• Registration Number: NCT03313466
• Lead Sponsor: Kaiser Permanente

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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Study Start: 2018-03-13
• Primary Completion: 2018-06-19
• Study Completion: 2019-06-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136630

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iCBTI	Internet cognitive behavioral therapy for insomnia (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.
Usual care	Class in sleeping well and improving insomnia	Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.

Primary Outcome Measures

Name	Time	Method
Days supply of dispensed insomnia medications	One year	Days supply of dispensed insomnia medications up to one year after randomization.

Secondary Outcome Measures

Name	Time	Method
Health care inpatient and outpatient encounters	One year	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.

Trial Locations

Locations (1)

Kaiser Permanente Southern California; 🇺🇸 Pasadena, California, United States