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

Study Overview
=================
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.

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

Conditions
-----------------
Insomnia Disorder

Intervention / Treatment
-----------------
* Behavioral: CBT-I in person
* Behavioral: CBT-I via Telemedicine
* Other: No intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-I in person<br> | Behavioral: CBT-I in person<br>* 6 weeks of CBT-I in person, one 1-hour long session per week<br>|
| Experimental: CBT-I via telemedicine<br> | Behavioral: CBT-I via Telemedicine<br>* 6 weeks of CBT-I via telemedicine, one 1-hour long session per week<br>|
| Other: Waitlist Control<br>Patients in this arm will receive in person CBT-I treatment after conclusion of the study. | Other: No intervention<br>* Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, CBT-I