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CompletedNCT03328585Updated Oct 8, 2020

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

An interventional study of CBT-I in person and CBT-I via Telemedicine in Insomnia Disorder, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Insomnia Disorder

Keywords

  • CBT-I
  • Telemedicine
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    CBT-I in person

    Behavioral: CBT-I in person

  • Experimental
    CBT-I via telemedicine

    Behavioral: CBT-I via Telemedicine

  • Other
    Waitlist Control

    Patients in this arm will receive in person CBT-I treatment after conclusion of the study.

    Other: No intervention

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

05

What researchers measure

Primary outcomes

  1. Change in ISI scores

    Total score on the Insomnia Severity Index (0-28)

    Time frame: Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later

Secondary outcomes

  1. Change in actigraphic sleep efficiency

    Measured using an actigraph wristband

    Time frame: Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later

06

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
07

References and documents

Publications

  • 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. PubMed 34428360 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03328585
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Nov 21, 2017
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
Oct 8, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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