Recruiting

Telemedicine vs. CBT-I

Sponsor:

University of Arizona

Code:

NCT03267537

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telemedicine CBT-I

Conventional office-based CBT-I

Study Details

Brief summary:

Insomnia is a common medical condition that has a deleterious effect on emotional status, health-related quality of life, and has been associated with hospitalizations and all-cause mortality. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the comfort of their homes via the wireless iPAD and video chat software. In patients who are recently discharged from the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services is an important area of future research.

Conditions

Insomnia

Study ID

NCT03267537

Start date

Jun 13, 2017

Status verified date

Aug, 2017

Completion date

May 31, 2019

Anticipated

Primary completion date

May 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Medically ill patients with recent hospitalization who are being discharged to home.
  • ISI score of > 10 (chronic insomnia)
  • Age > 18 years
  • Ability to provide informed consent
  • Willingness to undergo sleep study

Exclusion Criteria:

  • Presence of untreated sleep disorder that requires treatment independent of insomnia (Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)
  • Patients with severe debilitating neurological disease (end-stage Alzheimer's, large stroke, or other debilitating neurological disease) or any other condition that renders patients incapable of providing informed consent
  • History of Bipolar disease; current or past (< 6 months) history of suicidality or suicidal ideation
  • Active substance abuse or alcoholism
  • Pregnancy or lactation

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conventional office-based CBT-I

CBT-I will be delivered by a licensed clinical psychologist in weekly sessions lasting up to 1 hour. There will be 6 CBT-I sessions over the course of therapy with the option of an additional 2 treatments if deemed necessary by the clinical psychologist.

experimental: Telemedicine based CBT-I

The treatment will be the exact same as the active comparator group, with the same clinical psychologist doing the office-based CBT-I, but will be administered through a telemedicine modality

Interventions

Telemedicine CBT-I

Will be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits

Conventional office-based CBT-I

Conventional office-based CBT-I

Primary outcome measure

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline and after receiving CBT-I (~6 weeks) ]

Central Contacts and Locations

Central contacts

Sairam Parthasarathy, MD

(520) 626-6109sparthasarathy@deptofmed.arizona.edu

Locations

University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South)

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Sairam Parthasarathy, MD

520-626-6109sparthasarathy@deptofmed.arizona.edu

Chris Morton

5206268457cjmorton@email.arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Sep 1, 2017

Last verified

Aug, 2017

Keywords

  • Insomnia
  • Sleep
  • Telemedicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2017-09-01.