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Clinical Trials/NCT03313466
NCT03313466
Completed
Not Applicable

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

Kaiser Permanente1 site in 1 country136,630 target enrollmentMarch 13, 2018
ConditionsInsomnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Kaiser Permanente
Enrollment
136630
Locations
1
Primary Endpoint
Days supply of dispensed insomnia medications
Status
Completed
Last Updated
5 years ago

Overview

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..

Registry
clinicaltrials.gov
Start Date
March 13, 2018
End Date
June 19, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Days supply of dispensed insomnia medications

Time Frame: One year

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

Secondary Outcomes

  • Health care inpatient and outpatient encounters(One year)

Study Sites (1)

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