Insomnia Disorder
Conditions
Keywords
CBT-I, Telemedicine
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.
Interventions
BEHAVIORALCBT-I in person
6 weeks of CBT-I in person, one 1-hour long session per week
BEHAVIORALCBT-I via Telemedicine
6 weeks of CBT-I via telemedicine, one 1-hour long session per week
OTHERNo intervention
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed