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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03328585
Other study ID # 827001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2017
Est. completion date October 1, 2020

Study information

Verified date October 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ISI scores Total score on the Insomnia Severity Index (0-28) Once at baseline assessment and once again at follow-up after CBT-I intervention approximately 9 weeks later
Secondary Change in actigraphic sleep efficiency Measured using an actigraph wristband Patients will wear the wristband for a week during sleep baseline assessment and again for a week at follow-up, approximately 8 weeks later
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