Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis

October 6, 2020 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet current DSM5 criteria for Insomnia Disorder as determined by clinician interview
  • ISI score greater than 14, with self-reported duration of insomnia of at least 3 months
  • Ability to read and speak English
  • Own a personal computer with an internet connection sufficient to utilize the SleepTM and REDCap platform
  • BMI less than 30
  • Between the ages of 21-50

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Individuals with an untreated sleep disorder other than insomnia (Individuals with sleep apnea who are adherent with CPAP treatment (average 4 hours use per night) will be eligible to participate)
  • A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months
  • Individuals with substance abuse/dependence, bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia, and other psychotic disorders
  • Individuals with prominent current suicidal or homicidal ideation
  • Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing, or cognitive impairment
  • Any use of medications or OTC products that might impact sleep or metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-I in person
Behavioral: CBT-I in person
6 weeks of CBT-I in person, one 1-hour long session per week
Experimental: CBT-I via telemedicine
Behavioral: CBT-I via Telemedicine
6 weeks of CBT-I via telemedicine, one 1-hour long session per week
Other: Waitlist Control
Patients in this arm will receive in person CBT-I treatment after conclusion of the study.
Other: No intervention
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ISI scores
Time Frame: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Total score on the Insomnia Severity Index (0-28)
Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in actigraphic sleep efficiency
Time Frame: Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later
Measured using an actigraph wristband
Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2017

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 827001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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