Telemedicine vs in-person delivery of cognitive behavioral treatment of insomnia: a mixed methods analysis

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  • participants needed
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Updated on 19 February 2024

Summary

Cognitive behavioral therapy for insomnia (CBT-I) has been the gold standard for the treatment of insomnia. There is a need to increase access to treatment, particularly for patients in more rural locations where providers may be scarce. One solution is to utilize telemedicine which is 'the use of electronic communications to provide and support health care when distance separates the provider from the patient'. So the purpose of the study is to determine if receiving CBT-I by video teleconferencing works just as well as in-person treatment.

Description

Your participation will last approximately 5-7 months depending on the group you are randomized in to. The first visit is a screening visit where you will be asked to answer questions about your sleep, thoughts, and feelings as well as a provide a fasting blood draw. If eligible, you will be provided two devices. One is a portable sleep monitoring device that you will wear for one night and a wrist worn device for one week. After study staff receive the devices back you will be randomized in to one of 3 groups: in-person CBT-I, CBT-I via Telemedicine, or a waitlist group where you will wait 8 weeks prior to starting in-person CBT-I. Following treatment, you will be given the wrist worn device to wear for a week and will come in to the office for another fasting blood draw and to answer questionnaires about 2 weeks after treatment. Three months after the end of treatment, you will be asked to complete a series of questionnaires online.

FAQ

If you are randomized to the waitlist control group, you will wait 8 weeks prior to starting treatment. After the 8 weeks, you will come in about an hour before your first treatment session to repeat a fasting blood draw and questionnaires. After this is completed, you will start treatment and follow the same structure as listed above. Following the end of the 3 months followup, you will be invited to participate in a phone interview regarding your experience of the treatment you received.

Details
Condition Insomnia,sleep,chronic sleep disturbance
Age 21years - 60years
Clinical Study IdentifierTX4825
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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