Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia

NCT03267537 | Unknown

• 1 other identifier: 1545864655443n/a
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

Insomnia; Sleep; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem \& 4=very severe problem) Change in ISI score will be assessed between baseline and following CBT-I treatment over a 6 week period.

  Baseline and after receiving CBT-I (~6 weeks)

Secondary Outcomes (1)

• Consumer Assessment of Health Plans Survey (CAHPS v4.0) item

  Administered at baseline and at the end of receiving CBT-I (~6 weeks)

Other Outcomes (7)

• Wake After Sleep Onset (WASO)

  Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)

• Sleep Onset Latency (SOL)

  Sleep diaries are completed daily and actiwatch is worn continuously during the treatment period (~6 weeks)

• Pittsburgh Sleep Quality Index (PSQI)

  Administered at baseline and at the end of receiving CBT-I (~6 weeks)

Study Arms (2)

Conventional office-based CBT-I

ACTIVE COMPARATOR

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.

Behavioral: Conventional office-based CBT-I

Telemedicine based CBT-I

EXPERIMENTAL

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

Behavioral: Telemedicine CBT-I

Interventions

Telemedicine CBT-I BEHAVIORAL

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

Telemedicine based CBT-I

Conventional office-based CBT-I BEHAVIORAL

Conventional office-based CBT-I

Conventional office-based CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

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

Tucson, Arizona, 85721, United States

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Sairam Parthasarathy, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observers will be blinded to subjects group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: August 30, 2017
• Study Start: June 13, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)