Back to resultsTrial of Internet-Based Cognitive Behavioral Therapy for Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet cognitive behavioral therapy for insomnia (iCBTI)
Class in sleeping well and improving insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
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.
Sites / Locations
- Kaiser Permanente Southern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
iCBTI
Usual care
Arm 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.
Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.
Outcomes
Primary Outcome Measures
Days supply of dispensed insomnia medications
Days supply of dispensed insomnia medications up to one year after randomization.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03313466
First Posted
October 9, 2017
Last Updated
May 27, 2020
Sponsor
Kaiser Permanente
Collaborators
Big Health Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03313466
Brief Title
Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia
Official Title
Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
June 19, 2018 (Actual)
Study Completion Date
June 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Big Health Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136630 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCBTI
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.
Intervention Type
Behavioral
Intervention Name(s)
Internet cognitive behavioral therapy for insomnia (iCBTI)
Intervention Description
An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.
Intervention Type
Behavioral
Intervention Name(s)
Class in sleeping well and improving insomnia
Intervention Description
A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.
Primary Outcome Measure Information:
Title
Days supply of dispensed insomnia medications
Description
Days supply of dispensed insomnia medications up to one year after randomization.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Health care inpatient and outpatient encounters
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Derose, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southern California
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33908343
Citation
Derose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021 Aug 1;17(8):1675-1684. doi: 10.5664/jcsm.9280.
Results Reference
derived
Learn more about this trial
Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia
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