Evidence map›Paper›PMID 37803393›Full record

ArticleTrials2023

Digital CBTI hubs as a treatment augmentation strategy in military clinics: study protocol for a pragmatic randomized clinical trial.

Anne Germain, Megan Wolfson, Matthew S Brock, Brian O'Reilly, Hunter Hearn, Shelley Knowles, Vincent Mysliwiec, Meredith L Wallace

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05490550 (Comparing Insomnia Care As Usual to Digital Augmentation), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05490550 naunknown statusnot on this map

Comparing Insomnia Care As Usual to Digital Augmentation

TypeinterventionalSponsorNoctem, LLCRan2023 to 2025Enrolled188ConditionsChronic InsomniaArmsCOAST-enhanced CBTI, Military Treatment Facility Insomnia Care As Usual
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 2 countries.

Anne GermainNOCTEM, LLC, 218 Oakland Avenue, Pittsburgh, PA, 15213, USA. anne@noctemhealth.com.ORCID http://orcid.org/0000-0001-6672-4800
Megan WolfsonNOCTEM, LLC, 218 Oakland Avenue, Pittsburgh, PA, 15213, USA.
Matthew S BrockDepartment of Sleep Medicine, Wilford Hall Ambulatory Surgical Center, 1100 Wilford Hall Loop, Lackland AFB, San Antonio, TX, 78236, USA.
Brian O'ReillyMadigan Army Medical Center, Joint Base Lewis-McChord, WA, 9040 Jackson Ave., Joint Base Lewis-McChord, WA, 98431, USA.
Hunter HearnCarl R. Darnall Army Medical Center, Sleep Disorder Center, 36065 Santa Fe Ave., Fort Hood, Fort Cavazos, TX, 76544, USA.
Shelley KnowlesCarl R. Darnall Army Medical Center, Sleep Disorder Center, 36065 Santa Fe Ave., Fort Hood, Fort Cavazos, TX, 76544, USA.
Vincent MysliwiecDepartment of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, 78229, USA.
Meredith L WallaceDepartment of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, USA.
Carl R. Darnall Army Medical Center · USInstituto Superior de Ciências e Tecnologia de Moçambique · MZMadigan Army Medical Center · USThe University of Texas Health Science Center at San Antonio · USUniversity of Pittsburgh · USWilford Hall Ambulatory Surgical Center · US

Funding

Joint Warfighter Medical Research Program W81XWH-22-2-0008
6 · The paper itself

Abstract

backgroundChronic insomnia is the most prevalent sleep disorder among military service members, and it compromises readiness, performance, and physical and mental health. Cognitive behavioral treatment for insomnia (CBTI) is the standard of care for the treatment of insomnia recommended by the VA/DoD Clinical Practice Guideline, the American Academy of Sleep Medicine, and the American College of Physicians. CBTI is highly effective but has limited scalability. It is often unavailable in clinical settings where service members receive sleep care. Digital technologies offer unique opportunities to scale and broaden the geographic reach of CBTI services and support increased patient access and engagement in behavioral sleep care. This study aims to evaluate the impact and acceptability of digital CBTI hubs to augment military treatment facilities' capabilities in behavioral sleep medicine.

methodsThis is a multi-site, non-inferiority randomized clinical trial designed to compare the effects of in-person (face-to-face or virtual) insomnia care as usual at three military sleep clinics versus CBTI delivered remotely and asynchronously through digital CBTI hubs. Digital CBTI hubs are led by licensed, certified clinicians who use NOCTEM's® evidence-based clinical decision support platform COAST™ (Clinician Operated Assistive Sleep Technology). Changes in insomnia severity and daytime symptoms of depression and anxiety will be compared at baseline, at 6-8 weeks, and at 3-month follow-up. Patient satisfaction with insomnia care as usual versus digital CBTI hubs will also be examined. We hypothesize that digital CBTI hubs will be non-inferior to insomnia care as usual for improvements in insomnia and daytime symptoms as well as patient satisfaction with insomnia care. DISCUSSION: Digital technology has a high potential to scale CBTI accessibility and delivery options required to meet the insomnia care needs of military service members. Digital CBTI hubs using COAST offer a novel approach to broaden service members' access to CBTI and to serve as an augmentation strategy for existing sleep services at military treatment facilities. The pragmatic approach leveraging technology in this trial has the potential to rapidly inform clinical practice within the Defense Health Agency as well as other healthcare systems.

trial registrationClinicalTrials.gov NCT05490550. Registered on 14 July 2023.

Indexed as

Cognitive Behavioral TherapyMilitary PersonnelSleep Initiation and Maintenance DisordersEquivalence Trials as TopicHumansPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSleepTreatment OutcomeChronic insomniaCognitive behavioral therapy for insomnia (CBTI)Digital CTBI hubsDigital technologyMilitaryMilitary treatment facilityVeteran

Identifiers

PMID37803393
PMCPMC10557157
OpenAlexW4387407930

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.