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Mental health
Protocol
A study protocol for a non-randomised comparison trial evaluating the feasibility and effectiveness of a mobile cognitive–behavioural programme with integrated coaching for anxious adults in primary care
  1. Eva Szigethy1,
  2. Francis Solano2,
  3. Meredith Wallace1,
  4. Dina L Perry3,
  5. Lauren Morrell4,
  6. Kathryn Scott5,
  7. Megan Jones Bell6,
  8. Megan Oser4
  1. 1 Department of Psychiatry and Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  2. 2 Department of Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  3. 3 UPMC Health Services Division, UPMC Community Medicine Inc, Renaissance Family Practice UPMC, Pittsburgh, Pennsylvania, USA
  4. 4 Lantern, San Francisco, California, USA
  5. 5 Consumer Health UPMC Enterprises, Pittsburgh, Pennsylvania, USA
  6. 6 Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA
  1. Correspondence to Dr Megan Oser; moser{at}golantern.com, moser{at}bwh.harvard.edu

Abstract

Introduction Generalised anxiety disorder (GAD) and subclinical GAD are highly prevalent in primary care. Unmanaged anxiety worsens quality of life in patients seen in primary care practices and leads to increased medical utilisation and costs. Programmes that teach patients cognitive–behavioural therapy (CBT) techniques have been shown to improve anxiety and to prevent the evolution of anxiety symptoms to disorders, but access and engagement have hampered integration of CBT into medical settings.

Methods and analysis This pragmatic study takes place in University of Pittsburgh Medical Center primary care practices to evaluate a coach-supported mobile cognitive– behavioural programme (Lantern) on anxiety symptoms and quality of life. Clinics were non-randomly assigned to either enhanced treatment as usual or Lantern. All clinics provide electronic screening for anxiety and, within clinics assigned to Lantern, patients meeting a threshold level of mild anxiety (ie, >5 on Generalised Anxiety Disorder 7-Item Questionnaire (GAD-7)) are referred to Lantern. The first study phase is aimed at establishing feasibility, acceptability and effectiveness. The second phase focuses on long-term impact on psychosocial outcomes, healthcare utilisation and clinic/provider adoption/sustainable implementation using a propensity score matched parallel group study design. Primary outcomes are changes in anxiety symptoms (GAD-7) and quality of life (Short-Form Health Survey) between baseline and 6-month follow-ups, comparing control and intervention. Secondary outcomes include provider and patient satisfaction, patient engagement, durability of changes in anxiety symptoms and quality of life over 12 months and the impact of Lantern on healthcare utilisation over 12 months. Patients from control sites will be matched to the patients who use the mobile app.

Ethics and dissemination Ethics and human subject research approval were obtained. A data safety monitoring board is overseeing trial data and ethics. Results will be communicated to participating primary care practices, published and presented at clinical and scientific conferences.

Trial registration number NCT03035019.

  • primary care
  • anxiety
  • quality of life
  • cognitive behavioural
  • mhealth
  • digital health

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-019108

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    Footnotes

    • Contributors ES, FS and MJB conceived this study. DLP, MO, ES and MW contributed to the study design. MO, LM, DLP, KS and ES were instrumental in their contributions with implementation. MW provided statistical expertise in the trial design and will conduct the statistical analyses. All authors approved the final manuscript.

    • Funding This research was funded by UPMC Enterprises.

    • Competing interests ES reports grants from NIH and personal fees from AbbVie Consultant, Sherman Prize and APPI. MJB, MO and LM report being a shareholder in Thrive Network (DBA, Lantern). KS is employed by UPMC Enterprises. UPMC Enterprises is an investor in Thrive Network.

    • Ethics approval University of Pittsburgh Medical School Institutional Review Board (protocol no 16040173).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Unpublished preliminary analyses are available to Lantern and UPMC Investigative team.

    • Author note This research is being conducted by the authors as part of their employment at the University of Pittsburgh Medical Center, University of Pittsburgh Enterprises and Thrive Network.