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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
62 participants
INTERVENTIONAL
2017-11-21
2020-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine
NCT03293745
Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
NCT03267537
Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia
NCT00328250
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
NCT01549899
Online or Face-to-face Treatment for Insomnia?
NCT01955850
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBT-I in person
CBT-I in person
6 weeks of CBT-I in person, one 1-hour long session per week
CBT-I via telemedicine
CBT-I via Telemedicine
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.
No intervention
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CBT-I in person
6 weeks of CBT-I in person, one 1-hour long session per week
CBT-I via Telemedicine
6 weeks of CBT-I via telemedicine, one 1-hour long session per week
No intervention
Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
827001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.