Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 136,630
- Locations
- 1
- Primary Endpoint
- Days supply of dispensed insomnia medications
Study 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..
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Internet cognitive behavioral therapy for insomnia (iCBTI) (Behavioral)
Usual care
Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.
Intervention: Class in sleeping well and improving insomnia (Behavioral)
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)