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

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-I in person
CBT-I via Telemedicine
No intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder focused on measuring CBT-I, Telemedicine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

CBT-I in person

CBT-I via telemedicine

Waitlist Control

Arm Description

Patients in this arm will receive in person CBT-I treatment after conclusion of the study.

Outcomes

Primary Outcome Measures

Change in ISI scores
Total score on the Insomnia Severity Index (0-28)

Secondary Outcome Measures

Change in actigraphic sleep efficiency
Measured using an actigraph wristband

Full Information

First Posted
October 20, 2017
Last Updated
October 6, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03328585
Brief Title
Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis
Official Title
Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
CBT-I, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I in person
Arm Type
Active Comparator
Arm Title
CBT-I via telemedicine
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
Patients in this arm will receive in person CBT-I treatment after conclusion of the study.
Intervention Type
Behavioral
Intervention Name(s)
CBT-I in person
Intervention Description
6 weeks of CBT-I in person, one 1-hour long session per week
Intervention Type
Behavioral
Intervention Name(s)
CBT-I via Telemedicine
Intervention Description
6 weeks of CBT-I via telemedicine, one 1-hour long session per week
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study
Primary Outcome Measure Information:
Title
Change in ISI scores
Description
Total score on the Insomnia Severity Index (0-28)
Time Frame
Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Secondary Outcome Measure Information:
Title
Change in actigraphic sleep efficiency
Description
Measured using an actigraph wristband
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34428360
Citation
Gehrman P, Gunter P, Findley J, Frasso R, Weljie AM, Kuna ST, Kayser MS. Randomized Noninferiority Trial of Telehealth Delivery of Cognitive Behavioral Treatment of Insomnia Compared to In-Person Care. J Clin Psychiatry. 2021 Aug 24;82(5):20m13723. doi: 10.4088/JCP.20m13723.
Results Reference
derived

Learn more about this trial

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

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