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

Insomnia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328585
• Other study ID #: 827001
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• CBT-I in person
6 weeks of CBT-I in person, one 1-hour long session per week
• CBT-I via Telemedicine
6 weeks of CBT-I via telemedicine, one 1-hour long session per week

Other:
• No intervention
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ISI scores	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	Change in actigraphic sleep efficiency	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