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

NCT ID: NCT03267537

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2019-05-31

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.

Detailed Description

Insomnia is a common and distressing medical condition that affects nearly 20% of U.S. adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a community-based prospective observational study, preliminary data suggests that insomnia is associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy, stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators found a high prevalence of insomnia (80%) and were able to administer CBT-I in the participants' home via iPADs with wireless connectivity and secure video-chat software. 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 patient's homes via the wireless iPAD and video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I without the added expense of an iPAD. The investigators are proposing to perform a non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based CBT-I that is performed in patients with insomnia who have been recently discharged from the hospital. The investigators will measure the following outcomes: insomnia severity index (primary outcome) and patient satisfaction. In the future, the investigators' program of research aims to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services.

Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on insomnia severity in recently hospitalized patients.

Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 3-points less than that in patients treated by conventional office-based CBT-I.

Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on patient satisfaction.

Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 1-point less than that in patients treated by conventional office-based CBT-I.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional office-based CBT-I

Intervention Type: BEHAVIORAL

Conventional office-based CBT-I

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

Group Type: EXPERIMENTAL

Telemedicine CBT-I

Intervention Type: 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

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

Intervention Type: BEHAVIORAL

Conventional office-based CBT-I

Conventional office-based CBT-I

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Sleep Medicine

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Sairam Parthasarathy

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sairam Parthasarathy, MD

Role: CONTACT

sparthasarathy@deptofmed.arizona.edu

(520) 626-6109

Facility Contacts

Sairam Parthasarathy, MD

Role: primary

sparthasarathy@deptofmed.arizona.edu

520-626-6109

Chris Morton

Role: backup

cjmorton@email.arizona.edu

5206268457

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Other Identifiers

1545864655443n/a

Identifier Type: -

Identifier Source: org_study_id