Status:

COMPLETED

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

Lead Sponsor:

University of Pennsylvania

Conditions:

Insomnia Disorder

Eligibility:

All Genders

21+ years

Phase:

NA

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 l...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 21 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2020

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT03328585

Start Date

November 21 2017

End Date

October 1 2020

Last Update

October 8 2020

Active Locations (1)

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1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104