Guided Digital Cognitive Behavioral Program for Anxiety in Primary Care: Propensity-Matched Controlled Trial

Megan Oser, Meredith L Wallace, Francis Solano, Eva Maria Szigethy, Megan Oser, Meredith L Wallace, Francis Solano, Eva Maria Szigethy

Abstract

Background: Cognitive behavioral therapy (CBT) is the gold standard treatment for adult anxiety disorders but is often not readily available in a scalable manner in many clinical settings.

Objective: This study examines the feasibility, acceptability, and effectiveness of a coach-facilitated digital cognitive behavioral program for anxious adults in primary care.

Methods: In an open trial, patients who screened positive for anxiety (General Anxiety Disorder-7 [GAD7] score ≥5) were offered the digital cognitive behavioral program (active group, n=593). Primary outcomes included anxiety, quality of life (QoL), and ambulatory medical use over 6 months. Intent-to-treat (ITT) and modified intent-to-treat (mITT) analyses were completed. Subsequently, we compared the outcomes of participants with those of a matched control group receiving primary care as usual (CAU; n=316).

Results: More than half of the patients downloaded the cognitive behavioral mobile app program and about 60% of these were considered engaged, which was defined as completion of ≥3 techniques. The active group demonstrated medium size effects on reducing anxiety symptoms (effect size d=0.44; P<.001) and improving mental health QoL (d=0.49; P<.001) and showed significantly improved physical health QoL (d=0.39; P=.002) and a decreased likelihood of high utilization of outpatient medical care (odds ratio=0.49; P<.001). The active group did not significantly outperform the CAU group in anxiety reduction or QoL improvement (d=0.20; P=.07). However, intent-to-treat analysis showed that the active group had a significantly lower likelihood of high utilization of outpatient medical care than the enhanced CAU group (P<.0001; odds ratio=0.09).

Conclusions: A coach-facilitated digital cognitive behavioral program prescribed in primary care is feasible and acceptable. Primary care patients prescribed a digital cognitive behavioral program for anxiety experienced significant improvements in anxiety symptoms, QoL, and reduced medical utilization. This effect was observed even among patients with chronic medical conditions and behavioral health comorbidities. Although the primary outcomes in the active group did not improve significantly more than the CAU group, health care utilization declined, and some secondary outcomes improved in participants who engaged in the program compared to the CAU group.

Trial registration: ClinicalTrials.gov NCT03186872; https://ichgcp.net/clinical-trials-registry/NCT03186872.

Keywords: anxiety; cognitive behavioral; digital; mobile; primary care; technology.

Conflict of interest statement

Conflicts of Interest: EMS received grants from NIH and consultant fees from AbbVie and APPI. MO was a shareholder in Thrive Network, Inc (DBA, Lantern) at the time this study was conducted. UPMC Enterprises has a financial interest in Thrive Network, Inc, which develops and commercializes Lantern’s products and services. EMS is a scientific advisor and consultant to UPMC Enterprises. MLW and FS have no competing financial interests. MLW is an independent statistician.

©Megan Oser, Meredith L Wallace, Francis Solano, Eva Maria Szigethy. Originally published in JMIR Mental Health (http://mental.jmir.org), 04.04.2019.

Figures

Figure 1
Figure 1
Example of Lantern screenshots.
Figure 2
Figure 2
Participant flow sheet.

References

    1. Deacon B, Lickel J, Abramowitz JS. Medical utilization across the anxiety disorders. J Anxiety Disord. 2008;22(2):344–50. doi: 10.1016/j.janxdis.2007.03.004.
    1. Kessler R, Stafford D. Collaborative Medicine Case Studies: Evidence in Practice. NY: Springer; 2008. Primary Care Is the De Facto Mental Health System.
    1. Wang PS, Lane M, Olfson M, Pincus HA, Wells KB, Kessler RC. Twelve-month use of mental health services in the United States: results from the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):629–40. doi: 10.1001/archpsyc.62.6.629.
    1. Weisberg RB, Beard C, Moitra E, Dyck I, Keller MB. Adequacy of treatment received by primary care patients with anxiety disorders. Depress Anxiety. 2014 May;31(5):443–50. doi: 10.1002/da.22209.
    1. Weisberg RB, Magidson JF. Integrating cognitive behavioral therapy into primary care settings. Cogn Behav Pract. 2014 Aug;21(3):247–251. doi: 10.1016/j.cbpra.2014.04.002.
    1. Shafran R, Clark DM, Fairburn CG, Arntz A, Barlow DH, Ehlers A, Freeston M, Garety PA, Hollon SD, Ost LG, Salkovskis PM, Williams JMG, Wilson GT. Mind the gap: Improving the dissemination of CBT. Behav Res Ther. 2009 Nov;47(11):902–9. doi: 10.1016/j.brat.2009.07.003.
    1. Luik AI, Kyle SD, Espie CA. Digital Cognitive Behavioral Therapy (dCBT) for Insomnia: a State-of-the-Science Review. Curr Sleep Med Rep. 2017 May;3(2):48–56. doi: 10.1007/s40675-017-0065-4.
    1. Andrews G, Newby JM, Williams AD. Internet-delivered cognitive behavior therapy for anxiety disorders is here to stay. Curr Psychiatry Rep. 2015 Jan;17(1):533. doi: 10.1007/s11920-014-0533-1.
    1. Firth J, Torous J, Nicholas J, Carney R, Rosenbaum S, Sarris J. Can smartphone mental health interventions reduce symptoms of anxiety? A meta-analysis of randomized controlled trials. J Affect Disord. 2017 Dec 15;218:15–22. doi: 10.1016/j.jad.2017.04.046.
    1. Berger T, Urech A, Krieger T, Stolz T, Schulz A, Vincent A, Moser CT, Moritz S, Meyer B. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med. 2017 Dec;47(1):67–80. doi: 10.1017/S0033291716002270.
    1. Newby JM, Mackenzie A, Williams AD, McIntyre K, Watts S, Wong N, Andrews G. Internet cognitive behavioural therapy for mixed anxiety and depression: a randomized controlled trial and evidence of effectiveness in primary care. Psychol Med. 2013 Dec;43(12):2635–48. doi: 10.1017/S0033291713000111.
    1. Szigethy E, Solano F, Wallace M, Perry DL, Morrell L, Scott K, Bell MJ, Oser M. 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. BMJ Open. 2018 Dec 13;8(1):e019108. doi: 10.1136/bmjopen-2017-019108.
    1. Yu JS, Szigethy E, Wallace M, Solano F, Oser M. Implementation of a Guided, Digital Cognitive Behavioral Program for Anxiety in Primary Care: Preliminary Findings of Engagement and Effectiveness. Telemed J E Health. 2018 Feb 26; doi: 10.1089/tmj.2017.0280.
    1. Lantern. [2019-01-16].
    1. Newman M, Borkovec T. Cognitive-behavioral treatment of generalized anxiety disorder. The Clinical Psychologist. 1995;48(4):5–7.
    1. Newman MG, Przeworski A, Consoli AJ, Taylor CB. A randomized controlled trial of ecological momentary intervention plus brief group therapy for generalized anxiety disorder. Psychotherapy (Chic) 2014 Jun;51(2):198–206. doi: 10.1037/a0032519.
    1. National Institute of Mental Health. 2016. [2018-12-12]. Generalized Anxiety Disorder: When Worry Gets Out Of Control .
    1. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7. doi: 10.1001/archinte.166.10.1092.
    1. Kroenke K, Spitzer R, Williams J, Monahan P, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 06;146(5):317–25.
    1. Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016;39:24–31. doi: 10.1016/j.genhosppsych.2015.11.005.
    1. Gandek B, Ware J, Aaronson N, Apolone G, Bjorner J, Brazier J, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171–8.
    1. Narrow W, Clarke D, Kuramoto S, Kraemer H, Kupfer D, Greiner L, Regier D. DSM-5 field trials in the United States and Canada, Part III: development and reliability testing of a cross-cutting symptom assessment for DSM-5. Am J Psychiatry. 2013 Jan;170(1):71–82. doi: 10.1176/appi.ajp.2012.12071000.
    1. Clarke DE, Kuhl EA. DSM-5 cross-cutting symptom measures: a step towards the future of psychiatric care? World Psychiatry. 2014 Oct;13(3):314–6. doi: 10.1002/wps.20154. doi: 10.1002/wps.20154.
    1. Jakobsen J, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 06;17(1):162. doi: 10.1186/s12874-017-0442-1.
    1. Armijo-Olivo S, Warren S, Magee D. Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: a review. Physical Therapy Reviews. 2013 Jul 19;14(1):36–49. doi: 10.1179/174328809X405928.
    1. Gupta S. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109–12. doi: 10.4103/2229-3485.83221.
    1. Rosenbaum P, Rubin D. Reducing Bias in Observational Studies Using Subclassification on the Propensity Score. Journal of the American Statistical Association. 1984 Sep;79(387):516–524. doi: 10.1080/01621459.1984.10478078.
    1. Morrison L, Geraghty A, Lloyd S, Goodman N, Michaelides D, Hargood C, Weal M, Yardley L. Comparing usage of a web and app stress management intervention: An observational study. Internet Interv. 2018 Jun;12:74–82. doi: 10.1016/j.invent.2018.03.006.
    1. Yardley L, Spring B, Riper H, Morrison L, Crane D, Curtis K, Merchant G, Naughton F, Blandford A. Understanding and Promoting Effective Engagement With Digital Behavior Change Interventions. Am J Prev Med. 2016 Dec;51(5):833–842. doi: 10.1016/j.amepre.2016.06.015.
    1. Mohr D, Duffecy J, Ho J, Kwasny M, Cai X, Burns M, Begale M. A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS One. 2013;8(8):e70086. doi: 10.1371/journal.pone.0070086.
    1. Helander E, Kaipainen K, Korhonen I, Wansink B. Factors related to sustained use of a free mobile app for dietary self-monitoring with photography and peer feedback: retrospective cohort study. J Med Internet Res. 2014 Apr 15;16(4):e109. doi: 10.2196/jmir.3084.
    1. Lattie E, Schueller S, Sargent E, Stiles-Shields C, Tomasino K, Corden M, Begale M, Karr C, Mohr D. Uptake and Usage of IntelliCare: A Publicly Available Suite of Mental Health and Well-Being Apps. Internet Interv. 2016 May;4(2):152–158. doi: 10.1016/j.invent.2016.06.003.
    1. Mohr D, Tomasino K, Lattie E, Palac H, Kwasny M, Weingardt K, Karr C, Kaiser S, Rossom R, Bardsley L, Caccamo L, Stiles-Shields C, Schueller S. IntelliCare: An Eclectic, Skills-Based App Suite for the Treatment of Depression and Anxiety. J Med Internet Res. 2017 Dec 05;19(1):e10. doi: 10.2196/jmir.6645.
    1. Donkin L, Hickie I, Christensen H, Naismith S, Neal B, Cockayne N, Glozier N. Rethinking the dose-response relationship between usage and outcome in an online intervention for depression: randomized controlled trial. J Med Internet Res. 2013 Oct 17;15(10):e231. doi: 10.2196/jmir.2771.
    1. Saul J, Amato M, Cha S, Graham A. Engagement and attrition in Internet smoking cessation interventions: Insights from a cross-sectional survey of "one-hit-wonders". Internet Interv. 2016 Sep;5:23–29. doi: 10.1016/j.invent.2016.07.001.
    1. Ainsworth B, Steele M, Stuart B, Joseph J, Miller S, Morrison L, Little P, Yardley L. Using an Analysis of Behavior Change to Inform Effective Digital Intervention Design: How Did the PRIMIT Website Change Hand Hygiene Behavior Across 8993 Users? Ann Behav Med. 2017 Jun;51(3):423–431. doi: 10.1007/s12160-016-9866-9.
    1. Beard C, Weisberg R, Keller M. Health-related Quality of Life across the anxiety disorders: findings from a sample of primary care patients. J Anxiety Disord. 2010 Aug;24(6):559–64. doi: 10.1016/j.janxdis.2010.03.015.
    1. Barrera T, Norton P. Quality of life impairment in generalized anxiety disorder, social phobia, and panic disorder. J Anxiety Disord. 2009 Dec;23(8):1086–90. doi: 10.1016/j.janxdis.2009.07.011.
    1. Rapaport M, Clary C, Fayyad R, Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am J Psychiatry. 2005 Jun;162(6):1171–8. doi: 10.1176/appi.ajp.162.6.1171.
    1. Gill S, Butterworth P, Rodgers B, Mackinnon A. Validity of the mental health component scale of the 12-item Short-Form Health Survey (MCS-12) as measure of common mental disorders in the general population. Psychiatry Res. 2007 Jul 30;152(1):63–71. doi: 10.1016/j.psychres.2006.11.005.
    1. Vilagut G, Forero C, Pinto-Meza A, Haro J, de Graaf R, Bruffaerts R, Kovess V, de Girolamo G, Matschinger H, Ferrer M, Alonso J, ESEMeD Investigators The mental component of the short-form 12 health survey (SF-12) as a measure of depressive disorders in the general population: results with three alternative scoring methods. Value Health. 2013 Jun;16(4):564–73. doi: 10.1016/j.jval.2013.01.006.
    1. Comer J, Blanco C, Hasin D, Liu S, Grant B, Turner B, Olfson M. Health-related quality of life across the anxiety disorders: results from the national epidemiologic survey on alcohol and related conditions (NESARC) J Clin Psychiatry. 2011 Jan;72(1):43–50. doi: 10.4088/JCP.09m05094blu.
    1. Hofmann S, Wu J, Boettcher H. Effect of cognitive-behavioral therapy for anxiety disorders on quality of life: a meta-analysis. J Consult Clin Psychol. 2014 Jun;82(3):375–91. doi: 10.1037/a0035491.
    1. Oser M, Szigethy E, Wallace Ml, Weaver EK, Culp A, Kogan J, Regueiro MD. Randomized Adaptive Trial of Digital Behavioral Program for Anxiety and Depression in IBD Patient Centered Medical Home. Gastroenterology. 2018 May;154(6):S-153. doi: 10.1016/S0016-5085(18)30927-2.
    1. Newman M, Kanuri N, Ruzek J, Kuhn E, Thomas N, Abbott J, Jones M, Sharma S, Talyor C. A randomized controlled trial of feasibility, acceptability,efficacy of online, CBT-based guided self-help programs to reduce anxiety among Indian universities. Anxiety and Depression Association of America Annual Conference; April, 2016; Philadelphia, PA. 2016.
    1. Torous J, Firth J. The digital placebo effect: mobile mental health meets clinical psychiatry. Lancet Psychiatry. 2016 Feb;3(2):100–2. doi: 10.1016/S2215-0366(15)00565-9.

Source: PubMed

3
Abonnere