Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial

Dominique Servant, Anne-Claire Leterme, Olivia Barasino, Laure Rougegrez, Alain Duhamel, Guillaume Vaiva, Dominique Servant, Anne-Claire Leterme, Olivia Barasino, Laure Rougegrez, Alain Duhamel, Guillaume Vaiva

Abstract

Background: Adjustment disorder with anxiety (ADA) is the most frequent and best characterized stress-related psychiatric disorder. The rationale for prescription of benzodiazepine monotherapy is a public health issue. Cognitive behavioral stress management programs have been studied in many countries. Several reports have shown beyond reasonable doubt their efficiency at reducing perceived stress and anxiety symptoms and improving patient quality of life. Considering the number of people who could benefit from such programs but are unable to access them, self-help programs have been offered. First presented as books, these programs became enriched with computer-based and digital supports. Regrettably, programs for stress management based on cognitive behavioral therapy (CBT), both face-to-face and digital support, have been only minimally evaluated in France. To our knowledge, the Seren@ctif program is the first French language self-help program for stress management using digital supports.

Objective: The aim of this study is to assess the effectiveness of a 5-week standardized stress management program for reducing anxiety conducted via eLearning (iCBT) or through face-to-face interviews (CBT) with patients suffering from ADA compared with a wait list control group (WLC). These patients seek treatment in a psychiatric unit for anxiety disorders at a university hospital. The primary outcome is change in the State Trait Anxiety Inventory scale trait subscale (STAI-T) between baseline and 2-month visit.

Methods: This is a multicenter, prospective, open label, randomized controlled study in 3 parallel groups with balanced randomization (1:1:1): computer-based stress management with minimal contact (not fully automated) (group 1), stress management with face-to-face interviews (group 2), and a WLC group that receives usual health care from a general practitioner (group 3). Programs are based on standard CBT principles and include 5 modules in 5 weekly sessions that include the following topics: stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive restructuring, mindfulness, and acceptance; behavioral skills as problem solving; and time management, healthy behaviors, and emotion regulation. In the Internet-based group, patients have minimal contact with a medical professional before and after every session. In the first session, a flash memory drive is supplied containing videos, audio files, a self-help book portfolio in the form of an eGuide, and log books providing the exercises to be completed between 2 sessions. The patient is encouraged to practice a 20-minute daily exercise 5 or 6 times per week. In the face-to-face group, patients receive the same program from a therapist with 5 weekly sessions without digital support. Interviews and self-assessments were collected face-to-face with the investigator.

Results: The feasibility of this program is being tested, and results show good accessibility in terms of acceptance, understanding, and treatment credibility. Results are expected in 2018.

Conclusions: To our knowledge, this is the first French study to examine the effectiveness of a computer-based stress management program for patients with ADA. The Seren@ctif program may be useful within the framework of a psychoeducative approach. It could also be advised for people suffering from other diseases related to stress and for people with a clinical level of perceived stress.

Trial registration: Clinicaltrials.gov NCT02621775; https://ichgcp.net/clinical-trials-registry/NCT02621775 (Archived by WebCite at http://www.webcitation.org/6tQrkPs1u).

Keywords: adjustment disorders; behavior therapy; cognitive therapy; computer-assisted therapy; eHealth; psychological stress; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: None declared.

©Dominique Servant, Anne-Claire Leterme, Olivia Barasino, Laure Rougegrez, Alain Duhamel, Guillaume Vaiva. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.10.2017.

Figures

Figure 1
Figure 1
Flowchart of the study.

References

    1. Sauter SL, Murphy LR, Hurrell JJ. Prevention of work-related psychological disorders. A national strategy proposed by the National Institute for Occupational Safety and Health (NIOSH) Am Psychol. 1990 Oct;45(10):1146–1158.
    1. Fernández A, Mendive JM, Salvador-Carulla L, Rubio-Valera M, Luciano JV, Pinto-Meza A, Haro JM, Palao DJ, Bellón JA, Serrano-Blanco A, DASMAP investigators Adjustment disorders in primary care: prevalence, recognition and use of services. Br J Psychiatry. 2012 Aug;201:137–142. doi: 10.1192/bjp.bp.111.096305.
    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 5th Edition. Washington: American Psychiatric Association; 2013.
    1. Servant D, Pelissolo A, Chancharme L, Le Guern M, Boulenger J. [Adjustment disorders with anxiety. Clinical and psychometric characteristics in patients consulting a general practitioner] Encephale. 2013 Oct;39(5):347–351. doi: 10.1016/j.encep.2012.10.004.
    1. Casey P. Adjustment disorder: new developments. Curr Psychiatry Rep. 2014 Jun;16(6):451. doi: 10.1007/s11920-014-0451-2.
    1. Dugas MJ, Brillon P, Savard P, Turcotte J, Gaudet A, Ladouceur R, Leblanc R, Gervais NJ. A randomized clinical trial of cognitive-behavioral therapy and applied relaxation for adults with generalized anxiety disorder. Behav Ther. 2010 Mar;41(1):46–58. doi: 10.1016/j.beth.2008.12.004.
    1. Leichsenring F, Salzer S, Jaeger U, Kächele H, Kreische R, Leweke F, Rüger U, Winkelbach C, Leibing E. Short-term psychodynamic psychotherapy and cognitive-behavioral therapy in generalized anxiety disorder: a randomized, controlled trial. Am J Psychiatry. 2009 Aug;166(8):875–881. doi: 10.1176/appi.ajp.2009.09030441.
    1. Maercker A, Bachem RC, Lorenz L, Moser CT, Berger T. Adjustment disorders are uniquely suited for eHealth interventions: concept and case study. JMIR Ment Health. 2015;2(2):e15. doi: 10.2196/mental.4157.
    1. Ong L, Linden W, Young S. Stress management: what is it? J Psychosom Res. 2004 Jan;56(1):133–137. doi: 10.1016/S0022-3999(03)00128-4.
    1. Turner L, Linden W, van der Wal R, Schamberger W. Stress management for patients with heart disease: a pilot study. Heart Lung. 1995;24(2):145–153.
    1. Campbell TS, Stevenson A, Arena R, Hauer T, Bacon SL, Rouleau CR, Cannon C, Stone JA. An investigation of the benefits of stress management within a cardiac rehabilitation population. J Cardiopulm Rehabil Prev. 2012;32(5):296–304. doi: 10.1097/HCR.0b013e318265e0eb.
    1. Attari A, Sartippour M, Amini M, Haghighi S. Effect of stress management training on glycemic control in patients with type 1 diabetes. Diabetes Res Clin Pract. 2006 Jul;73(1):23–28. doi: 10.1016/j.diabres.2005.11.014.
    1. Lopez C, Antoni M, Penedo F, Weiss D, Cruess S, Segotas M, Helder L, Siegel S, Klimas N, Fletcher MA. A pilot study of cognitive behavioral stress management effects on stress, quality of life, and symptoms in persons with chronic fatigue syndrome. J Psychosom Res. 2011 Apr;70(4):328–334. doi: 10.1016/j.jpsychores.2010.11.010.
    1. Nzila N, Laga M, Thiam MA, Mayimona K, Edidi B, Behets F, Hassig S, Nelson A, Mokwa K. HIV and other sexually transmitted diseases among female prostitutes in Kinshasa. AIDS. 1991 Jun;5(6):715–721.
    1. Bhui KS, Dinos S, Stansfeld SA, White PD. A synthesis of the evidence for managing stress at work: a review of the reviews reporting on anxiety, depression, and absenteeism. J Environ Public Health. 2012;2012:515874. doi: 10.1155/2012/515874. doi: 10.1155/2012/515874.
    1. Richardson KM, Rothstein HR. Effects of occupational stress management intervention programs: a meta-analysis. J Occup Health Psychol. 2008 Jan;13(1):69–93. doi: 10.1037/1076-8998.13.1.69.
    1. Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155–159.
    1. Sharma V, Sood A, Prasad K, Loehrer L, Schroeder D, Brent B. Bibliotherapy to decrease stress and anxiety and increase resilience and mindfulness: a pilot trial. Explore (NY) 2014;10(4):248–252. doi: 10.1016/j.explore.2014.04.002.
    1. Abramowitz JS, Moore EL, Braddock AE, Harrington DL. Self-help cognitive-behavioral therapy with minimal therapist contact for social phobia: a controlled trial. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):98–105. doi: 10.1016/j.jbtep.2008.04.004.
    1. Andersson G. Using the Internet to provide cognitive behaviour therapy. Behav Res Ther. 2009 Mar;47(3):175–180. doi: 10.1016/j.brat.2009.01.010.
    1. Matcham F, Rayner L, Hutton J, Monk A, Steel C, Hotopf M. Self-help interventions for symptoms of depression, anxiety and psychological distress in patients with physical illnesses: a systematic review and meta-analysis. Clin Psychol Rev. 2014 Mar;34(2):141–157. doi: 10.1016/j.cpr.2014.01.005.
    1. Kawai K, Yamazaki Y, Nakayama K. Process evaluation of a Web-based stress management program to promote psychological well-being in a sample of white-collar workers in Japan. Ind Health. 2010;48(3):265–274.
    1. Zetterqvist K, Maanmies J, Ström L, Andersson G. Randomized controlled trial of internet-based stress management. Cogn Behav Ther. 2003;32(3):151–160. doi: 10.1080/16506070302316.
    1. Cook RF, Billings DW, Hersch RK, Back AS, Hendrickson A. A field test of a Web-based workplace health promotion program to improve dietary practices, reduce stress, and increase physical activity: randomized controlled trial. J Med Internet Res. 2007;9(2):e17. doi: 10.2196/jmir.9.2.e17.
    1. Beatty L, Lambert S. A systematic review of internet-based self-help therapeutic interventions to improve distress and disease-control among adults with chronic health conditions. Clin Psychol Rev. 2013 Jun;33(4):609–622. doi: 10.1016/j.cpr.2013.03.004.
    1. Rose RD, Buckey JC, Zbozinek TD, Motivala SJ, Glenn DE, Cartreine JA, Craske MG. A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Behav Res Ther. 2013 Feb;51(2):106–112. doi: 10.1016/j.brat.2012.11.003.
    1. Clarke J, Proudfoot J, Birch M, Whitton AE, Parker G, Manicavasagar V, Harrison V, Christensen H, Hadzi-Pavlovic D. Effects of mental health self-efficacy on outcomes of a mobile phone and web intervention for mild-to-moderate depression, anxiety and stress: secondary analysis of a randomised controlled trial. BMC Psychiatry. 2014;14:272. doi: 10.1186/s12888-014-0272-1.
    1. Ruwaard J, Lange A, Schrieken B, Dolan CV, Emmelkamp P. The effectiveness of online cognitive behavioral treatment in routine clinical practice. PLoS One. 2012;7(7):e40089. doi: 10.1371/journal.pone.0040089.
    1. van Straten A, Cuijpers P, Smits N. Effectiveness of a Web-based self-help intervention for symptoms of depression, anxiety, and stress: randomized controlled trial. J Med Internet Res. 2008;10(1):e7. doi: 10.2196/jmir.954.
    1. Grime PR. Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism. Occup Med (Lond) 2004 Aug;54(5):353–359. doi: 10.1093/occmed/kqh077.
    1. Heber E, Lehr D, Ebert DD, Berking M, Riper H. Web-based and mobile stress management intervention for employees: a randomized controlled trial. J Med Internet Res. 2016;18(1):e21. doi: 10.2196/jmir.5112.
    1. Ahtinen A, Mattila E, Välkkynen P, Kaipainen K, Vanhala T, Ermes M, Sairanen E, Myllymäki T, Lappalainen R. Mobile mental wellness training for stress management: feasibility and design implications based on a one-month field study. JMIR Mhealth Uhealth. 2013;1(2):e11. doi: 10.2196/mhealth.2596.
    1. Ebert DD, Lehr D, Heber E, Riper H, Cuijpers P, Berking M. Internet- and mobile-based stress management for employees with adherence-focused guidance: efficacy and mechanism of change. Scand J Work Environ Health. 2016 Sep 01;42(5):382–394. doi: 10.5271/sjweh.3573.
    1. Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344–351. doi: 10.1016/j.brat.2013.03.003.
    1. Glück TM, Maercker A. A randomized controlled pilot study of a brief Web-based mindfulness training. BMC Psychiatry. 2011;11:175. doi: 10.1186/1471-244X-11-175.
    1. Frazier P, Meredith L, Greer C, Paulsen JA, Howard K, Dietz LR, Qin K. Randomized controlled trial evaluating the effectiveness of a Web-based stress management program among community college students. Anxiety Stress Coping. 2015;28(5):576–586. doi: 10.1080/10615806.2014.987666.
    1. Heber E, Ebert DD, Lehr D, Cuijpers P, Berking M, Nobis S, Riper H. The benefit of Web- and computer-based interventions for stress: a systematic review and meta-analysis. J Med Internet Res. 2017 Feb 17;19(2):e32. doi: 10.2196/jmir.5774.
    1. Servant D, Rougegrez L, Barasino O, Demarty A, Duhamel A, Vaiva G. [Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program] Encephale. 2016 Oct;42(5):415–420. doi: 10.1016/j.encep.2016.03.010.
    1. Mehring M, Haag M, Linde K, Wagenpfeil S, Schneider A. Effects of a Web-based intervention for stress reduction in primary care: a cluster randomized controlled trial. J Med Internet Res. 2016 Feb 12;18(2):e27. doi: 10.2196/jmir.4246.
    1. Drozd F, Raeder S, Kraft P, Bjørkli CA. Multilevel growth curve analyses of treatment effects of a Web-based intervention for stress reduction: randomized controlled trial. J Med Internet Res. 2013;15(4):e84. doi: 10.2196/jmir.2570.
    1. Lucini D, Solaro N, Lesma A, Gillet VB, Pagani M. Health promotion in the workplace: assessing stress and lifestyle with an intranet tool. J Med Internet Res. 2011 Nov 08;13(4):e88. doi: 10.2196/jmir.1798.
    1. Zarski A, Lehr D, Berking M, Riper H, Cuijpers P, Ebert DD. Adherence to Internet-based mobile-supported stress management: a pooled analysis of individual participant data from three randomized controlled trials. J Med Internet Res. 2016;18(6):e146. doi: 10.2196/jmir.4493.
    1. Zhu B, Hedman A, Feng S, Li H, Osika W. Designing, prototyping and evaluating digital mindfulness applications: a case study of mindful breathing for stress reduction. J Med Internet Res. 2017 Jun 14;19(6):e197. doi: 10.2196/jmir.6955.
    1. Þórarinsdóttir H, Kessing LV, Faurholt-Jepsen M. Smartphone-based self-assessment of stress in healthy adult individuals: a systematic review. J Med Internet Res. 2017 Feb 13;19(2):e41. doi: 10.2196/jmir.6397.
    1. Donker T, Petrie K, Proudfoot J, Clarke J, Birch M, Christensen H. Smartphones for smarter delivery of mental health programs: a systematic review. J Med Internet Res. 2013;15(11):e247. doi: 10.2196/jmir.2791.
    1. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22–34.
    1. Lecrubier Y, Sheehan D, Weiller E, Amorim P, Bonora I, Harnett Sheehan K, Janavs J, Dunbar G. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. European Psychiatry. 1997;12(5):224–231. doi: 10.1016/S0924-9338(97)83296-8.
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191–1194.
    1. Spielberger C. Manual for the State-Trait Anxiety Inventory (Form Y) Self-Evaluation Questionnaire. Palo Alto: Consulting Psychologist Press; 1983.
    1. Bruchon-Schweitzer M, Paulhan I. In: Inventaire d'anxiété, état-trait: forme Y (STAI-Y) Adaptation française. Spielberger CD, editor. Paris: Les Editions du Centre de Psychologie Appliquée; 1993.
    1. Olssøn I, Mykletun A, Dahl AA. The Hospital Anxiety and Depression Rating Scale: a cross-sectional study of psychometrics and case finding abilities in general practice. BMC Psychiatry. 2005 Dec 14;5:46. doi: 10.1186/1471-244X-5-46.
    1. Lépine JP, Godchau M, Brun P, Lempérière T. [Evaluation of anxiety and depression among patients hospitalized on an internal medicine service] Ann Med Psychol (Paris) 1985 Feb;143(2):175–189.
    1. Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487–495.
    1. Gosselin P, Dugas MJ, Ladouceur R, Freeston MH. [Evaluation of worry: validation of a French translation of the Penn State Worry Questionnaire] Encephale. 2001;27(5):475–484.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385–396.
    1. Lesage F, Berjot S, Deschamps F. Psychometric properties of the French versions of the Perceived Stress Scale. Int J Occup Med Environ Health. 2012 Jun;25(2):178–184. doi: 10.2478/S13382-012-0024-8. doi: 10.2478/S13382-012-0024-8.
    1. Lesage F, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond) 2012 Dec;62(8):600–605. doi: 10.1093/occmed/kqs140.
    1. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561–571.
    1. Pichot P, Lemperiere T. Analyse factorielle d'un questionnaire d'auto-évaluation des symptômes dépressifs. Revue Psychologie Appliquée. 1964:15.
    1. Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2016 Mar 12;3:CD011565. doi: 10.1002/14651858.CD011565.pub2.
    1. Dugas MJ, Brillon P, Savard P, Turcotte J, Gaudet A, Ladouceur R, Leblanc R, Gervais NJ. A randomized clinical trial of cognitive-behavioral therapy and applied relaxation for adults with generalized anxiety disorder. Behav Ther. 2010 Mar;41(1):46–58. doi: 10.1016/j.beth.2008.12.004.
    1. Leichsenring F, Salzer S, Jaeger U, Kächele H, Kreische R, Leweke F, Rüger U, Winkelbach C, Leibing E. Short-term psychodynamic psychotherapy and cognitive-behavioral therapy in generalized anxiety disorder: a randomized, controlled trial. Am J Psychiatry. 2009 Aug;166(8):875–881. doi: 10.1176/appi.ajp.2009.09030441.
    1. Vickers AJ. Parametric versus non-parametric statistics in the analysis of randomized trials with non-normally distributed data. BMC Med Res Methodol. 2005 Nov 03;5:35. doi: 10.1186/1471-2288-5-35.
    1. Conover WJ, Iman RL. Analysis of covariance using the rank transformation. Biometrics. 1982 Sep;38(3):715–724.
    1. Van Buuren S, Groothuis-Oudshoorn K. MICE: Multivariate Imputation by Chained Equations in R. J Stat Softw. 2011
    1. Rubin D. Multiple Imputation for Nonresponse in Surveys. New York: John Wiley and Sons; 1987.
    1. Li K, Meng X, Raghunathan T, Rubin D. Significance levels from repeated p-values with multiply-imputed data. Statistica Sinica. 1991;1(1):65–92.
    1. Eysenbach G. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13(4):e126. doi: 10.2196/jmir.1923.

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