Guided Self-Help Works: Randomized Waitlist Controlled Trial of Pacifica, a Mobile App Integrating Cognitive Behavioral Therapy and Mindfulness for Stress, Anxiety, and Depression

Christine Moberg, Andrea Niles, Dale Beermann, Christine Moberg, Andrea Niles, Dale Beermann

Abstract

Background: Despite substantial improvements in technology and the increased demand for technology-enabled behavioral health tools among consumers, little progress has been made in easing the burden of mental illness. This may be because of the inherent challenges of conducting traditional clinical trials in a rapidly evolving technology landscape.

Objective: This study sought to validate the effectiveness of Pacifica, a popular commercially available app for the self-management of mild-to-moderate stress, anxiety, and depression.

Methods: A total of 500 adults with mild-to-moderate anxiety or depression were recruited from in-app onboarding to participate in a randomized waitlist controlled trial of Pacifica. We conducted an all-virtual study, recruiting, screening, and randomizing participants through a Web-based participant portal. Study participants used the app for 1 month, with no level of use required, closely mimicking real-world app usage. Participants in the waitlist group were given access to the app after 1 month. Measurements included self-reported symptoms of stress, anxiety, depression, and self-efficacy. We performed an intent-to-treat analysis to examine the interactive effects of time and condition.

Results: We found significant interactions between time and group. Participants in the active condition demonstrated significantly greater decreases in depression, anxiety, and stress and increases in self-efficacy. Although we did not find a relationship between overall engagement with the app and symptom improvement, participants who completed relatively more thought record exercises sustained improvements in their symptoms through the 2-month follow-up to a greater degree than those who completed fewer. In addition, we found that participants who reported concomitantly taking psychiatric medications during the trial benefitted less from the app, as measured by the symptoms of anxiety and stress.

Conclusions: This study provides evidence that Pacifica, a popular commercially available self-help app, is effective in reducing self-reported symptoms of depression, anxiety, and stress, particularly among individuals who utilize thought records and are not taking psychiatric medication.

Trial registration: ClinicalTrials.gov NCT03333707; https://ichgcp.net/clinical-trials-registry/NCT03333707 (Archived by WebCite at http://www.webcitation.org/78YE07ADB).

Keywords: anxiety; cognitive behavioral therapy; depression; mHealth; smartphone app; stress.

Conflict of interest statement

Conflicts of Interest: At the time of this study, CM was the Head of Psychology, owned options in Pacifica Labs, Inc, and was receiving a salary from the company. DB was the Cofounder and CEO of Pacifica Labs, Inc, owned a large share of the company’s stock, and received a salary from the company.

©Christine Moberg, Andrea Niles, Dale Beermann. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.06.2019.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram.
Figure 2
Figure 2
Key outcome measures by group and time. DASS: Depression Anxiety Stress Scales.
Figure 3
Figure 3
Interaction between use of "Thoughts" tool and anxiety and stress outcomes. DASS: Depression Anxiety Stress Scales.
Figure 4
Figure 4
Moderation of group by time effect by participant self-reported psychiatric medication use. DASS: Depression Anxiety Stress Scales.

References

    1. National Comorbidity Survey (NCS) 2017. [2019-05-20]. .
    1. Key Substance Use and Mental Health Indicators in the United States: Results from the 2016 National Survey on Drug Use and Health. Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration; 2017.
    1. Beck J. Cognitive Behavior Therapy, Second Edition. New York, NY: Guilford Press; 2011. p. 9781609185046.
    1. DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):409–16. doi: 10.1001/archpsyc.62.4.409.
    1. Butler A, Chapman J, Forman E, Beck A. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17–31. doi: 10.1016/j.cpr.2005.07.003.
    1. Hofmann S, Asnaani A, Vonk I, Sawyer A, Fang A. The efficacy of cognitive behavioral therapy: a review of meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427–40. doi: 10.1007/s10608-012-9476-1.
    1. Bruns E, Kerns S, Pullmann M, Hensley S, Lutterman T, Hoagwood KE. Research, data, and evidence-based treatment use in state behavioral health systems, 2001-2012. Psychiatr Serv. 2016 Dec 1;67(5):496–503. doi: 10.1176/appi.ps.201500014.
    1. Insel T. Assessing the economic costs of serious mental illness. Am J Psychiatry. 2008 Jun;165(6):663–5. doi: 10.1176/appi.ajp.2008.08030366.
    1. Keyes CG, Grzywacz JG. Health as a complete state: the added value in work performance and healthcare costs. J Occup Environ Med. 2005 May;47(5):523–32.
    1. Rice D, Miller LS. Health economics and cost implications of anxiety and other mental disorders in the United States. Br J Psychiatry Suppl. 1998;(34):4–9.
    1. Kaiser Family Foundation Analysis of Data from Institute for Health MetricsEvaluation Peterson-Kaiser Health System Tracker. 2015. [2019-05-20]. Global Burden of Disease Study, 2015
    1. Espie C, Kyle S, Williams C, Ong J, Douglas N, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769–81. doi: 10.5665/sleep.1872.
    1. Hedman E, Furmark T, Carlbring P, Ljótsson B, Rück C, Lindefors N, Andersson G. A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder. J Med Internet Res. 2011 Jun 15;13(2):e39. doi: 10.2196/jmir.1776.
    1. Kaltenthaler E, Parry G, Beverley C, Ferriter M. Computerised cognitive-behavioural therapy for depression: systematic review. Br J Psychiatry. 2008 Sep;193(3):181–4. doi: 10.1192/bjp.bp.106.025981.
    1. Pretorius N, Arcelus J, Beecham J, Dawson H, Doherty F, Eisler I, Gallagher C, Gowers S, Isaacs G, Johnson-Sabine E, Jones A, Newell C, Morris J, Richards L, Ringwood S, Rowlands L, Simic M, Treasure J, Waller G, Williams C, Yi I, Yoshioka M, Schmidt U. Cognitive-behavioural therapy for adolescents with bulimic symptomatology: the acceptability and effectiveness of internet-based delivery. Behav Res Ther. 2009 Sep;47(9):729–36. doi: 10.1016/j.brat.2009.05.006.
    1. Vis C, Mol M, Kleiboer A, Bührmann L, Finch T, Smit J, Riper H. Improving implementation of eMental health for mood disorders in routine practice: systematic review of barriers and facilitating factors. JMIR Ment Health. 2018 Mar 16;5(1):e20. doi: 10.2196/mental.9769.
    1. Torous J, Nicholas J, Larsen M, Firth J, Christensen H. Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements. Evid Based Ment Health. 2018 Aug;21(3):116–119. doi: 10.1136/eb-2018-102891.
    1. Stawarz K, Preist C, Tallon D, Wiles N, Coyle D. User experience of cognitive behavioral therapy apps for depression: an analysis of app functionality and user reviews. J Med Internet Res. 2018 Dec 6;20(6):e10120. doi: 10.2196/10120.
    1. Alkhaldi Ghadah, Hamilton F, Lau R, Webster R, Michie S, Murray E. The effectiveness of prompts to promote engagement with digital interventions: a systematic review. J Med Internet Res. 2016 Jan 8;18(1):e6. doi: 10.2196/jmir.4790.
    1. Baekeland F, Lundwall L. Dropping out of treatment: a critical review. Psychol Bull. 1975 Sep;82(5):738–83.
    1. Lebeau RT, Davies C, Culver N, Craske M. Homework compliance counts in cognitive-behavioral therapy. Cogn Behav Ther. 2013;42(3):171–9. doi: 10.1080/16506073.2013.763286.
    1. Clarke G, Kelleher C, Hornbrook M, Debar L, Dickerson J, Gullion C. Randomized effectiveness trial of an Internet, pure self-help, cognitive behavioral intervention for depressive symptoms in young adults. Cogn Behav Ther. 2009;38(4):222–34. doi: 10.1080/16506070802675353.
    1. Kelders SM, Bohlmeijer ET, van Gemert-Pijnen JW. Participants, usage, and use patterns of a web-based intervention for the prevention of depression within a randomized controlled trial. J Med Internet Res. 2013 Aug 20;15(8):e172. doi: 10.2196/jmir.2258.
    1. van Gemert-Pijnen JE, Kelders SM, Bohlmeijer ET. Understanding the usage of content in a mental health intervention for depression: an analysis of log data. J Med Internet Res. 2014 Jan 31;16(1):e27. doi: 10.2196/jmir.2991.
    1. Høifødt RS, Mittner M, Lillevoll K, Katla S, Kolstrup N, Eisemann M, Friborg O, Waterloo K. Predictors of response to web-based cognitive behavioral therapy with high-intensity face-to-face therapist guidance for depression: a Bayesian analysis. J Med Internet Res. 2015 Sep 2;17(9):e197. doi: 10.2196/jmir.4351.
    1. Myhr G, Talbot J, Annable L, Pinard G. Suitability for short-term cognitive-behavioral therapy. J Cogn Psychother. 2007 Dec 1;21(4):334–45. doi: 10.1891/088983907782638743.
    1. Dryman M, McTeague L, Olino T, Heimberg R. Evaluation of an open-access CBT-based Internet program for social anxiety: patterns of use, retention, and outcomes. J Consult Clin Psychol. 2017 Oct;85(10):988–99. doi: 10.1037/ccp0000232.
    1. Birney A, Gunn R, Russell J, Ary D. MoodHacker mobile web app with email for adults to self-manage mild-to-moderate depression: randomized controlled trial. JMIR Mhealth Uhealth. 2016 Jan 26;4(1):e8. doi: 10.2196/mhealth.4231.
    1. Anguera J, Jordan J, Castaneda D, Gazzaley A, Areán PA. Conducting a fully mobile and randomised clinical trial for depression: access, engagement and expense. BMJ Innov. 2016 Jan;2(1):14–21. doi: 10.1136/bmjinnov-2015-000098.
    1. Arean P, Hallgren K, Jordan J, Gazzaley A, Atkins D, Heagerty P, Anguera JA. The use and effectiveness of mobile apps for depression: results from a fully remote clinical trial. J Med Internet Res. 2016 Dec 20;18(12):e330. doi: 10.2196/jmir.6482.
    1. Pacifica Labs. Pacifica: Version 5.7 through 5.9.1. San Francisco, CA: Pacifica Labs, Inc; 2017.
    1. Wampold B. How important are the common factors in psychotherapy? An update. World Psychiatr. 2015 Oct;14(3):270–7. doi: 10.1002/wps.20238. doi: 10.1002/wps.20238.
    1. Spitzer R, Kroenke K, Williams J, 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, Strine T, Spitzer R, Williams J, Berry J, Mokdad A. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163–73. doi: 10.1016/j.jad.2008.06.026.
    1. Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. Br J Health Psychol. 2010 Feb;15(Pt 1):1–39. doi: 10.1348/135910709X466063.
    1. Schueller S, Aguilera A, Mohr D. Ecological momentary interventions for depression and anxiety. Depress Anxiety. 2017 Dec;34(6):540–5. doi: 10.1002/da.22649.
    1. Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. Second Edition. Sydney, Aus: Psychology Foundation; 1995. p. 733414230.
    1. Antony M, Bieling PJ, Cox BJ, Enns MW, Swinson RP. Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychol Asses. 1998 Jun;10(2):176–81. doi: 10.1037/1040-3590.10.2.176.
    1. Kroenke K, Spitzer R, Williams J. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606–13. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, Johnston M, editors. Measures in Health Psychology: A User's Portfolio. Causal and Control Beliefs. Windsor, England: NFER-NELSON; 1995. pp. 35–7.
    1. Scholz U, Gutiérrez Doña B, Sud S, Schwarzer R. Is general self-efficacy a universal construct? Psychometric findings from 25 countries. Eur J of Psych Assess. 2002 Sep;18(3):242–51. doi: 10.1027//1015-5759.18.3.242.
    1. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626–9. doi: 10.1016/j.jpsychires.2010.10.008.
    1. StataCorp . Stata Statistical Software: Release 15. College Station, TX: StataCorp; 2017.
    1. Craske M, Niles A, Burklund L, Wolitzky-Taylor K, Vilardaga J, Arch J, Saxbe DE, Lieberman MD. Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators. J Consult Clin Psychol. 2014 Dec;82(6):1034–48. doi: 10.1037/a0037212.
    1. Niles A, Craske M, Lieberman M, Hur C. Affect labeling enhances exposure effectiveness for public speaking anxiety. Behav Res Ther. 2015 May;68:27–36. doi: 10.1016/j.brat.2015.03.004.
    1. Roy-Byrne P, Craske MG, Sullivan G, Rose RD, Edlund MJ, Lang AJ, Bystritsky A, Welch SS, Chavira DA, Golinelli D, Campbell-Sills L, Sherbourne CD, Stein MB. Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial. J Am Med Assoc. 2010 May 19;303(19):1921–8. doi: 10.1001/jama.2010.608.
    1. Wolitzky-Taylor K, Niles A, Ries R, Krull J, Rawson R, Roy-Byrne P, Craske M. Who needs more than standard care? Treatment moderators in a randomized clinical trial comparing addiction treatment alone to addiction treatment plus anxiety disorder treatment for comorbid anxiety and substance use disorders. Behav Res Ther. 2018 Dec;107:1–9. doi: 10.1016/j.brat.2018.05.005.
    1. Feingold A. Effect sizes for growth-modeling analysis for controlled clinical trials in the same metric as for classical analysis. Psychol Methods. 2009 Mar;14(1):43–53. doi: 10.1037/a0014699.
    1. Jacobson N, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12–9.
    1. Longmore RJ, Worrell M. Do we need to challenge thoughts in cognitive behavior therapy? Clin Psychol Rev. 2007 Mar;27(2):173–87. doi: 10.1016/j.cpr.2006.08.001.
    1. DiMauro J, Domingues J, Fernandez G, Tolin DF. Long-term effectiveness of CBT for anxiety disorders in an adult outpatient clinic sample: a follow-up study. Behav Res Ther. 2013 Feb;51(2):82–6. doi: 10.1016/j.brat.2012.10.003.
    1. Hollon S, DeRubeis R, Shelton R, Amsterdam J, Salomon R, O'Reardon J, Lovett ML, Young PR, Haman KL, Freeman BB, Gallop R. Prevention of relapse following cognitive therapy vs medications in moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):417–22. doi: 10.1001/archpsyc.62.4.417.
    1. Button K, Turner N, Campbell J, Kessler D, Kuyken W, Lewis G, Peters TJ, Thomas L, Wiles N. Moderators of response to cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care. J Affect Disord. 2015 Mar 15;174:272–80. doi: 10.1016/j.jad.2014.11.057.
    1. Fournier J, DeRubeis R, Shelton R, Hollon S, Amsterdam J, Gallop R. Prediction of response to medication and cognitive therapy in the treatment of moderate to severe depression. J Consult Clin Psychol. 2009 Aug;77(4):775–87. doi: 10.1037/a0015401.
    1. Wolitzky-Taylor KB, Arch JJ, Rosenfield D, Craske MG. Moderators and non-specific predictors of treatment outcome for anxiety disorders: a comparison of cognitive behavioral therapy to acceptance and commitment therapy. J Consult Clin Psychol. 2012 Oct;80(5):786–99. doi: 10.1037/a0029418.
    1. El Alaoui S, Ljótsson B, Hedman E, Kaldo V, Andersson E, Rück C, Andersson G, Lindefors N. Predictors of symptomatic change and adherence in internet-based cognitive behaviour therapy for social anxiety disorder in routine psychiatric care. PLoS One. 2015;10(4):e0124258. doi: 10.1371/journal.pone.0124258.
    1. Berger T, Hämmerli K, Gubser N, Andersson G, Caspar F. Internet-based treatment of depression: a randomized controlled trial comparing guided with unguided self-help. Cogn Behav Ther. 2011 Dec;40(4):251–66. doi: 10.1080/16506073.2011.616531.
    1. Ruwaard J, Schrieken B, Schrijver M, Broeksteeg J, Dekker J, Vermeulen H, Lange A. Standardized web-based cognitive behavioural therapy of mild to moderate depression: a randomized controlled trial with a long-term follow-up. Cogn Behav Ther. 2009 Dec;38(4):206–21. doi: 10.1080/16506070802408086.
    1. Spek V, Cuijpers P, Nyklícek I, Smits N, Riper H, Keyzer J, Pop V. One-year follow-up results of a randomized controlled clinical trial on internet-based cognitive behavioural therapy for subthreshold depression in people over 50 years. Psychol Med. 2008 May;38(5):635–9. doi: 10.1017/S0033291707002590.
    1. Vernmark K, Lenndin J, Bjärehed J, Carlsson M, Karlsson J, Oberg J, Carlbring P, Eriksson T, Andersson G. Internet administered guided self-help versus individualized e-mail therapy: a randomized trial of two versions of CBT for major depression. Behav Res Ther. 2010 May;48(5):368–76. doi: 10.1016/j.brat.2010.01.005.
    1. Cuijpers P, Sijbrandij M, Koole S, Andersson G, Beekman A, Reynolds C. Adding psychotherapy to antidepressant medication in depression and anxiety disorders: a meta-analysis. World Psychiatry. 2014 Feb;13(1):56–67. doi: 10.1002/wps.20089. doi: 10.1002/wps.20089.
    1. Otto M, Smits J, Reese H. Combined psychotherapy and pharmacotherapy for mood and anxiety disorders in adults: Review and analysis. Clin Psych Sci Pract. 2005;12:72–86. doi: 10.1093/clipsy.bpi009.
    1. Otto MW, McHugh R, Kantak KM. Combined pharmacotherapy and cognitive-behavioral therapy for anxiety disorders: medication effects, glucocorticoids, and attenuated treatment outcomes. Clin Psychol (New York) 2010 Jun 1;17(2):91–103. doi: 10.1111/j.1468-2850.2010.01198.x.
    1. Baumeister H, Reichler L, Munzinger M, Lin J. The impact of guidance on Internet-based mental health interventions - a systematic review. Internet Interv. 2014 Oct;1(4):205–15. doi: 10.1016/j.invent.2014.08.003.
    1. Scogin F, Hanson A, Welsh D. Self-administered treatment in stepped-care models of depression treatment. J Clin Psychol. 2003 Mar;59(3):341–9. doi: 10.1002/jclp.10133.
    1. Olfson M, Blanco C, Wang S, Laje G, Correll C. National trends in the mental health care of children, adolescents, and adults by office-based physicians. JAMA Psychiatry. 2014 Jan;71(1):81–90. doi: 10.1001/jamapsychiatry.2013.3074.
    1. Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schröder J, Bretón-López J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of self-guided internet-based cognitive behavioral therapy in the treatment of depressive symptoms: a meta-analysis of individual participant data. JAMA Psychiatry. 2017 Apr 1;74(4):351–9. doi: 10.1001/jamapsychiatry.2017.0044.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj