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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03328585

Collaborator

(none)

Enrollment

Location

Arms

34.3

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia Disorder	Behavioral: CBT-I in person Behavioral: CBT-I via Telemedicine Other: No intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2017

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in ISI scores [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)

Secondary Outcome Measures

Change in actigraphic sleep efficiency [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT03328585

Other Study ID Numbers:

827001

First Posted:

Nov 1, 2017

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Pennsylvania

CBT-I

Telemedicine

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Oct 8, 2020