Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313466
• Other study ID #: 11262
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: June 19, 2019

Study information

• Verified date: May 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136630
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Internet 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.
• Class in sleeping well and improving insomnia
A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Big Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days supply of dispensed insomnia medications	Days supply of dispensed insomnia medications up to one year after randomization.	One year
Secondary	Health care inpatient and outpatient encounters	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.	One year