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Completed

NCT Number: NCT03313466

Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

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..

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet cognitive behavioral therapy for insomnia (iCBTI)

Behavioral

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

Behavioral

A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.

Primary outcomes

  1. Days supply of dispensed insomnia medications

    Time frame: One year

    Days supply of dispensed insomnia medications up to one year after randomization.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Big Health Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 18, 2017
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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