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

NCT ID: NCT03328585

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2020-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT-I in person

Group Type ACTIVE_COMPARATOR

CBT-I in person

Intervention Type BEHAVIORAL

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

CBT-I via telemedicine

Group Type EXPERIMENTAL

CBT-I via Telemedicine

Intervention Type BEHAVIORAL

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

Waitlist Control

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

Group Type OTHER

No intervention

Intervention Type OTHER

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

Interventions

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CBT-I in person

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

Intervention Type BEHAVIORAL

CBT-I via Telemedicine

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

Intervention Type BEHAVIORAL

No intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34428360 (View on PubMed)

Other Identifiers

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827001

Identifier Type: -

Identifier Source: org_study_id

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