Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

NCT03313466 — Not applicable, Completed, 136630 participants, Kaiser Permanente

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

Registry	NCT03313466
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	136630 (Actual)
Sponsor	Kaiser Permanente (Other); collaborators: Big Health Inc.
Conditions	Insomnia
Interventions	Internet cognitive behavioral therapy for insomnia (iCBTI), Class in sleeping well and improving insomnia (Behavioral)
Dates	start 2018-03-13, primary completion 2018-06-19, completion 2019-06-19, first posted 2017-10-18, last updated 2020-05-28
Locations	1 site in United States

-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..

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+Arms and interventions

Arm	Type	Interventions	Description
iCBTI	Experimental	Behavioral: 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	Active comparator	Behavioral: Class in sleeping well and improving insomnia	Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.

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.
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.

+Outcome measures

Primary outcomes

Days supply of dispensed insomnia medications [One year]: Days supply of dispensed insomnia medications up to one year after randomization.

Secondary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Kaiser Permanente Southern California	Pasadena, California	United States

+Publications

Results publication: 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

+Investigators

Stephen Derose, MD, Principal investigator, Kaiser Permanente