Clinical trial NCT03328585: 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
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Keywords: CBT-I
Telemedicine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in ISI scores
timeFrame: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Secondary outcomes:
measure: Change in actigraphic sleep efficiency
timeFrame: Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
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.