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Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03313466
Enrollment
136630
Registered
2017-10-18
Start date
2018-03-13
Completion date
2019-06-19
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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..

Interventions

BEHAVIORALInternet 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.

BEHAVIORALClass in sleeping well and improving insomnia

A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

Sponsors

Big Health Inc.
CollaboratorINDUSTRY
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Days supply of dispensed insomnia medicationsOne yearDays supply of dispensed insomnia medications up to one year after randomization.

Secondary

MeasureTime frameDescription
Health care inpatient and outpatient encountersOne yearNumber 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026