Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

Kaiser Permanente

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI); Behavioral: Class in sleeping well and improving insomnia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03313466

11262 (Registry Identifier)

Details and patient eligibility

About

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..

Enrollment: 136,630 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136,630 participants in 2 patient groups

iCBTI

Experimental group

Description:

Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions.

Treatment:

Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI)

Usual care

Active Comparator group

Description:

Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.

Treatment:

Behavioral: Class in sleeping well and improving insomnia