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Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

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ClinicalTrials.gov Identifier: NCT03313466
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Big Health
Information provided by (Responsible Party):
Kaiser Permanente

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..

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: iCBTI
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.




Primary Outcome Measures :
  1. Days supply of dispensed insomnia medications [ Time Frame: One year ]
    Days supply of dispensed insomnia medications up to one year after randomization.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, California
Kaiser Permanente Southern California
Pasadena, California, United States, 91101
Sponsors and Collaborators
Kaiser Permanente
Big Health
Investigators
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Principal Investigator: Stephen Derose, MD Kaiser Permanente
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03313466    
Other Study ID Numbers: 11262
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders