Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03313466|
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Internet cognitive behavioral therapy for insomnia (iCBTI) Behavioral: Class in sleeping well and improving insomnia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136630 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications|
|Actual Study Start Date :||March 13, 2018|
|Actual Primary Completion Date :||June 19, 2018|
|Actual Study Completion Date :||June 19, 2019|
Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions.
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.
Active Comparator: Usual care
Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.
Behavioral: 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.
- Days supply of dispensed insomnia medications [ Time Frame: One year ]Days supply of dispensed insomnia medications up to one year after randomization.
- Health care inpatient and outpatient encounters [ Time Frame: One year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313466
|United States, California|
|Kaiser Permanente Southern California|
|Pasadena, California, United States, 91101|
|Principal Investigator:||Stephen Derose, MD||Kaiser Permanente|