NCT03328585

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

October 20, 2017

Last Update Submit

October 6, 2020

Conditions

Insomnia Disorder

Keywords

CBT-ITelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in actigraphic sleep efficiency

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

Study Arms (3)

CBT-I in person

ACTIVE COMPARATOR
Behavioral: CBT-I in person

CBT-I via telemedicine

EXPERIMENTAL
Behavioral: CBT-I via Telemedicine

Waitlist Control

OTHER

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

Other: No intervention

Interventions

CBT-I in personBEHAVIORAL

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

CBT-I in person
CBT-I via TelemedicineBEHAVIORAL

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

CBT-I via telemedicine
No interventionOTHER

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

Waitlist Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 34428360DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

November 1, 2017

Study Start

November 21, 2017

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)