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OpenTrials
Completed

NCT Number: NCT03328585

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

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.

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Key information

Conditions

Insomnia Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-I in person

Behavioral

6 weeks of CBT-I in person, one 1-hour long session per week

CBT-I via Telemedicine

Behavioral

6 weeks of CBT-I via telemedicine, one 1-hour long session per week

No intervention

Other

Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study

Primary outcomes

  1. Change in ISI scores

    Time frame: 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 outcomes

  1. Change in actigraphic sleep efficiency

    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

    Measured using an actigraph wristband

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2017
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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