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

Not Applicable

Completed

• Conditions: Insomnia Disorder
• Interventions: Behavioral: CBT-I via Telemedicine; Behavioral: CBT-I in person; Other: No intervention

• Registration Number: NCT03328585
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2017-11-21
• Status Verified: 2020-10
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I via telemedicine	CBT-I via Telemedicine	-
CBT-I in person	CBT-I in person	-
Waitlist Control	No intervention	Patients in this arm will receive in person CBT-I treatment after conclusion of the study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States