Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial

Elena Heber, David Daniel Ebert, Dirk Lehr, Stephanie Nobis, Matthias Berking, Heleen Riper, Elena Heber, David Daniel Ebert, Dirk Lehr, Stephanie Nobis, Matthias Berking, Heleen Riper

Abstract

Background: Work-related stress is associated with a variety of mental and emotional problems and can lead to substantial economic costs due to lost productivity, absenteeism or the inability to work. There is a considerable amount of evidence on the effectiveness of traditional face-to-face stress-management interventions for employees; however, they are often costly, time-consuming, and characterized by a high access threshold. Web-based interventions may overcome some of these problems yet the evidence in this field is scarce. This paper describes the protocol for a study that will examine the efficacy and cost-effectiveness of a web-based guided stress-management training which is based on problem solving and emotion regulation and aimed at reducing stress in adult employees.

Methods: The study will target stressed employees aged 18 and older. A randomized controlled trial (RCT) design will be applied. Based on a power calculation of d=.35 (1-β of 80%, α = .05), 264 participants will be recruited and randomly assigned to either the intervention group or a six-month waitlist control group. Inclusion criteria include an elevated stress level (Cohen's Perceived Stress Scale-10 ≥ 22) and current employment. Exclusion criteria include risk of suicide or previously diagnosed psychosis or dissociative symptoms. The primary outcome will be perceived stress, and secondary outcomes include depression and anxiety. Data will be collected at baseline and seven weeks and six months after randomization. An extended follow up at 12 months is planned for the intervention group. Moreover, a cost-effectiveness analysis will be conducted from a societal perspective and will include both direct and indirect health care costs. Data will be analyzed on an intention-to-treat basis and per protocol.

Discussion: The substantial negative consequences of work-related stress emphasize the necessity for effective stress-management trainings. If the proposed internet intervention proves to be (cost-) effective, a preventative, economical stress-management tool will be conceivable. The strengths and limitations of the present study are discussed.

Trial registration: German Register of Clinical Studies (DRKS): DRKS00004749.

Figures

Figure 1
Figure 1
Study flow chart.

References

    1. Backé E, Seidler A, Latza U, Rossnagel K, Schumann B. The role of psychosocial stress at work for the development of cardiovascular diseases: a systematic review. Int Arch Occup Environ Health. 2012;85:67–79. doi: 10.1007/s00420-011-0643-6.
    1. Kivimäki M, Virtanen M, Elovainio M, Kouvonen A, Väänänen A, Vahtera J. Work stress in the etiology of coronary heart disease–a meta-analysis. Scand J Work Environ Health. 2006;32:431–442. doi: 10.5271/sjweh.1049.
    1. Stansfeld S, Candy B. Psychosocial work environment and mental health–a meta-analytic review. Scand J Work Environ Health. 2006;32:443–462. doi: 10.5271/sjweh.1050.
    1. Paoli P, Merllié D. Third European survey on working conditions 2000. Luxembourg: Office for Official Publications of the European Communities; 2001.
    1. Melchior M, Caspi A, Milne BJ, Danese A, Poulton R, Moffitt TE. Work stress precipitates depression and anxiety in young, working women and men. PsycholMed. 2007;37:1119–1129.
    1. Akerstedt T. Psychosocial stress and impaired sleep. Scand J Work Environ Health. 2006;32:493–501. doi: 10.5271/sjweh.1054.
    1. Moreau M. Occupational stress and incidence of sick leave in the Belgian workforce: the Belstress study. J Epidemiol Community Health. 2004;58:507–516. doi: 10.1136/jech.2003.007518.
    1. Ahola K, Toppinen-Tanner S, Huuhtanen P, Koskinen A, Väänänen A. Occupational burnout and chronic work disability: An eight-year cohort study on pensioning among Finnish forest industry workers. J Affect Disord. 2009;115:150–159. doi: 10.1016/j.jad.2008.09.021.
    1. Rosch PJ. The quandary of job stress compensation. Health and Stress. 2001;3:1–4.
    1. van der Klink JJL, Blonk RWB, Schene AH, van Dijk FJH. The benefits of interventions for work-related stress. Am J Public Health. 2001;91:270–276.
    1. Richardson KM, Rothstein HR. Effects of occupational stress management intervention programs: A meta-analysis. J Occup Health Psychol. 2008;13:69–93.
    1. Spek V, Cuijpers P, Nyklícek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: A meta-analysis. Psychol Med. 2007;37:319. doi: 10.1017/S0033291706008944.
    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:e7. doi: 10.2196/jmir.954.
    1. Zetterqvist K, Maanmies J, Ström L, Andersson G. Randomized controlled trial of internet-based stress management. Cognit Behav Ther. 2003;32:151–160. doi: 10.1080/16506070302316.
    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:e84. doi: 10.2196/jmir.2570.
    1. Ruwaard J, Lange A, Bouwman M, Broeksteeg J, Schrieken B. E‒Mailed standardized cognitive behavioural treatment of work‒related stress: A randomized controlled trial. Cognit Behav Ther. 2007;36:179–192. doi: 10.1080/16506070701381863.
    1. Chiauzzi E, Brevard J, Thurn C, Decembrele S, Lord S. MyStudentBody–Stress: An online stress management intervention for college students. J Health Commun. 2008;13:555–572. doi: 10.1080/10810730802281668.
    1. Wiegand B, Luedtke K, Friscia D, Nair M, Aleles M, McCloskey R. Efficacy of a comprehensive program for reducing stress in women: A prospective, randomized trial. Curr Med Res Opin. 2010;26:991–1002. doi: 10.1185/03007991003688193.
    1. Wade SL, Carey J, Wolfe CR. An online family intervention to reduce parental distress following pediatric brain injury. J Consult Clin Psychol. 2006;74:445–454.
    1. Hänggi Y. Kann web-basierte Stressprävention erfolgreich sein? [Can web-based parental training on coping with familiy stress be successful?] Z Klin Psychol Psychother. 2006;35:169–177. doi: 10.1026/1616-3443.35.3.169.
    1. Lange A, van de Ven J, Schrieken B, Smit M. 'Interapy' Burn-out: Prävention und Behandlung von Burn-out über das Internet [‘Interapy’ burnout: prevention and therapy of burnout via the internet] Verhaltenstherapie. 2004;14:190–199. doi: 10.1159/000080915.
    1. Billings DW, Cook RF, Hendrickson A, Dove DC. A web-based approach to managing stress and mood disorders in the workforce. J Occup Environ Med. 2008;50:960–968. doi: 10.1097/JOM.0b013e31816c435b.
    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:e17. doi: 10.2196/jmir.9.2.e17.
    1. Grime PR. Computerized cognitive behavioural therapy at work: A randomized controlled trial in employees with recent stress-related absenteeism. Occup Med. 2004;54:353–359. doi: 10.1093/occmed/kqh077.
    1. Hasson D, Anderberg U, Theorell T, Arnetz BB. Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers. BMC Public Health. 2005;5:78. doi: 10.1186/1471-2458-5-78.
    1. Abbott J, Klein B, Hamilton C, Rosenthal AJ. The impact of online resilience training for sales managers on wellbeing and performance. E-JAP. 2009;5:89–95.
    1. Eisen KP, Allen GJ, Bollash M, Pescatello LS. Stress management in the workplace: A comparison of a computer-based and an in-person stress-management intervention. Comput Hum Behav. 2008;24:486–496. doi: 10.1016/j.chb.2007.02.003.
    1. Hamberg-van Reenen HH, Proper KI, van den Berg M. Worksite mental health interventions: a systematic review of economic evaluations. Occup Environ Med. 2012;69:837–845. doi: 10.1136/oemed-2012-100668.
    1. Gärtner FR, Ketelaar SM, Smeets O, Bolier L, Fischer E, van Dijk FJH, Nieuwenhuijsen K, Sluiter JK. The Mental Vitality @ Work study: Design of a randomized controlled trial on the effect of a workers' health surveillance mental module for nurses and allied health professionals. BMC Public Health. 2011;11:290. doi: 10.1186/1471-2458-11-290.
    1. Geraedts AS, Kleiboer AM, Wiezer NM, van Mechelen W, Cuijpers P. Web-based guided self-help for employees with depressive symptoms (Happy@Work): Design of a randomized controlled trial. BMC Psychiatry. 2013;13:61. doi: 10.1186/1471-244X-13-61.
    1. Krusche A, Cyhlarova E, King S, Williams JMG. Mindfulness online: A preliminary evaluation of the feasibility of a web-based mindfulness course and the impact on stress. BMJ Open. 2012;2:e000803. doi: 10.1136/bmjopen-2011-000803.
    1. Shimazu A, Kawakami N, Irimajiri H, Sakamoto M, Amano S. Effects of web-based psychoeducation on self-efficacy, problem solving behavior, stress responses and job satisfaction among workers: A controlled clinical trial. J Occup Health Psychol. 2005;47:405–413. doi: 10.1539/joh.47.405.
    1. Karasek RA. Job demands, job decision latitude, and mental strain: Implications for job redesign. Admin Sci Quart. 1979;24:285–308. doi: 10.2307/2392498.
    1. Siegrist J. Reciprocity in basic social exchange and health: Can we reconcile person-based with population-based psychosomatic research? J Psychosom Res. 1998;45:99–105.
    1. Lazarus RS, Folkman S. Stress, appraisal, and coping. New York: Springer; 1984.
    1. van Vliet H, Andrews G. Internet-based course for the management of stress for junior high schools. Aust NZ J Psychiatry. 2009;43:305–309. doi: 10.1080/00048670902721145.
    1. Berking M, Ebert D, Cuijpers P, Hofmann SG. Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: A randomized controlled trial. Psychother Psychosom. 2013;82:234–245. doi: 10.1159/000348448.
    1. Ehring T, Tuschen-Caffier B, Schnülle J, Fischer S, Gross JJ. Emotion regulation and vulnerability to depression: Spontaneous versus instructed use of emotion suppression and reappraisal. Emotion. 2010;10:563–572.
    1. Liverant GI, Brown TA, Barlow DH, Roemer L. Emotion regulation in unipolar depression: The effects of acceptance and suppression of subjective emotional experience on the intensity and duration of sadness and negative affect. Behav Res Ther. 2008;46:1201–1209. doi: 10.1016/j.brat.2008.08.001.
    1. Cisler JM, Olatunji BO. Emotion regulation and anxiety disorders. Curr Psychiatry Rep. 2012;14:182–187. doi: 10.1007/s11920-012-0262-2.
    1. Berking M, Wupperman P. Emotion regulation and mental health: recent findings, current challenges, and future directions. Curr Opin Psychiatry. 2012;25:128–134. doi: 10.1097/YCO.0b013e3283503669.
    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;25:178–184. doi: 10.2478/S13382-012-0024-8.
    1. D'Zurilla T, Nezu A. Problem-Solving Therapy. In Handbook of cognitive-behavioral therapies. 3rd edition. Edited by Dobson KS. New York: Guilford Press; 2010.
    1. Donker T, van Straten A, Riper H, Marks I, Andersson G, Cuijpers P. The design of a randomized controlled trial. Trials. 2009. p. 59.
    1. Berking M. Training emotionaler Kompetenzen. 2. Berlin, Heidelberg: Springer-Verlag Berlin Heidelberg; 2010.
    1. Berking M, Meier C, Wupperman P. Enhancing emotion-regulation skills in police officers: Results of a pilot controlled study. Behav Ther. 2010;41:329–339. doi: 10.1016/j.beth.2009.08.001.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24:385–396. doi: 10.2307/2136404.
    1. Michalsen A, Jeitler M, Brunnhuber S, Lüdtke R, Büssing A, Musial F, Dobos G, Kessler C. Iyengar Yoga for distressed women: A 3-armed randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:1–9.
    1. Cohen S, Janicki-Deverts D. Who's stressed? Distributions of psychological stress in the United States in probability samples from 1983, 2006, and 2009. J Appl Soc Psychol. 2012;42:1320–1334. doi: 10.1111/j.1559-1816.2012.00900.x.
    1. Radloff LS. The CES-D Scale: A self-report depression scale for research in the general population. Appl Psych Meas. 1977;1:385–401. doi: 10.1177/014662167700100306.
    1. Hautzinger M, Bailer M. (Eds): Allgemeine Depressions Skala . Manual. Göttingen: Beltz Test GmbH; 1993.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Hermann-Lingen C, Buss U, Snaith R. Hospital Anxiety and Depression Scale - Deutsche Version (HADS-D) 3. Bern: Hans Huber; 2011.
    1. Büssing A, Glaser J. Managerial stress und burnout. A collaborative international study (CISMS). Die deutsche Untersuchung (Bericht Nr. 44) München: Technische Universität, Lehrstuhl für Psychologie; 1998.
    1. Schaufeli W, Leiter M, Maslach C, Jackson SE. Maslach Burnout Inventory - General Survey (MBI-GS). In Maslach Burnout Inventory Manual. Edited by Maslach C, Jackson SE, Leiter MP. Palo Alto, CA: Consulting Psychologists Press; 1996.
    1. Neubach B, Schmidt K. Gütekriterien einer deutschen Fassung des Maslach Burnout Inventory (MBI-D) - Eine Replikationsstudie bei Altenpflegekräften [Psychometric properties and validity of a German version of the Maslach Burnout Inventory (MBI—D): A replication study among professionals caring for the elderly] Z Arb Organ. 2000;44:140–156.
    1. Berking M, Znoj H. Entwicklung und Validierung eines Fragebogens zur standardisierten Selbsteinschätzung emotionaler Kompetenzen (SEK-27) [Development and validation of a self-report instrument for the assessment of emotion-specific regulation skills (ERSQ-27)] Z Psychiatr Psychol Psychother. 2008;56:141–153.
    1. Ebert D, Christ O, Berking M. Entwicklung und Validierung eines Fragebogens zur emotionsspezifischen Selbsteinschätzung emotionaler Kompetenzen (SEK-ES) [Development and validation of a self-report instrument for the assessment of emotion-specific regulation skills (ERSQ-ES)] Diagnostica. 2013;59:17–32. doi: 10.1026/0012-1924/a000079.
    1. Fischer EH, Farina A. Attitudes toward seeking professional psychological help: a shortened form and considerations for research. J Coll Student Dev. 1995;36:368–373.
    1. Schaufeli W. Bakker A (Eds): UWES - Utrecht Work Engagement Scale: Test Manual . Utrecht, The Netherlands: Department of Psychology, Utrecht University; 2003.
    1. Schaufeli W, Salanova M, González-Romá V, Bakker AB. The measurement of engagement and burnout: A two sample confirmatory factor analytic approach. J Happiness Stud. 2002;3:71–92. doi: 10.1023/A:1015630930326.
    1. Sonnentag S, Fritz C. The recovery experience questionnaire: Development and validation of a measure assessing recuperation and unwinding at work. J Occup Health Psychol. 2007;12:204–221.
    1. Morin CM. Insomnia: Psychological assessment and management. New York: Guilford Press; 1993.
    1. Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2:297–307. doi: 10.1016/S1389-9457(00)00065-4.
    1. Thorndike FP, Ritterband LM, Saylor DK, Magee JC, Gonder-Frederick LA, Morin CM. Validation of the insomnia severity index as a web-based measure. Behav Sleep Med. 2011;9:216–223. doi: 10.1080/15402002.2011.606766.
    1. Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34:601–608.
    1. Meyer T, Miller M, Metzger R, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28:487–495. doi: 10.1016/0005-7967(90)90135-6.
    1. Berle D, Starcevic V, Moses K, Hannan A, Milicevic D, Sammut P. Preliminary validation of an ultra-brief version of the Penn State Worry Questionnaire. Clin Psychol Psychother. 2011;18:339–346. doi: 10.1002/cpp.724.
    1. Stöber J, Bittencourt J. Weekly assessment of worry: An adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. Behav Res Ther. 1998;36:645–656. doi: 10.1016/S0005-7967(98)00031-X.
    1. Stöber J: PSWQ-PW. In: Diagnostische Verfahren in der Psychotherapie [Assessment procedures in psychotherapy. Brähler E, Schumacher J, Strauß B, editor. Göttingen, Germany: Hogrefe; 2002. Penn State Worry Questionnaire-Past Week; pp. 291–294.
    1. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–233. doi: 10.1097/00005650-199603000-00003.
    1. Group EQ. EuroQol - a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16:199–208.
    1. Krauth C. Methoden der Kostenbestimmung in der gesundheitsökonomischen Evaluation [Cost estimation methods in health economic evaluation] Gesundheitsökonomie & Qualitätsmanagement. 2010;15:251–259.
    1. Hakkaart-van Roijen L. Manual Trimbos/iMTA Questionnaire for costs associated with psychiatric illness (in Dutch) Rotterdam: Institute for Medical Technology Assessment; 2002.
    1. Siegrist J, Wege N, Pühlhofer F, Wahrendorf M. A short generic measure of work stress in the era of globalization: effort–reward imbalance. Int Arch Occup Environ Health. 2009;82:1005–1013. doi: 10.1007/s00420-008-0384-3.
    1. Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV) [Measurement of patient's therapy expectancy and therapy evaluation] Z Klin Psychol Psychother. 2005;34:176–187. doi: 10.1026/1616-3443.34.3.176.
    1. Schmidt J, Lamprecht F, Wittmann WW. Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies] Psychother Psychosom Med Psychol. 1989;39:248–255.
    1. Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5:233–237. doi: 10.1016/0149-7189(82)90074-X.
    1. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ. 1996;313:570–571. doi: 10.1136/bmj.313.7057.570.
    1. Eysenbach G. CONSORT-EHEALTH: Improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res. 2011;13:e126. doi: 10.2196/jmir.1923.
    1. Little RJA, Rubin DB. In: Wiley series in probability and statistics. 2 Hoboken NJ, editor. : Wiley; 2002. Statistical analysis with missing data.
    1. Schafer JL. Analysis of incomplete multivariate data. 1. Boca Raton: Chapman & Hall/CRC; 2000. [Monographs on statistics and applied probability, vol. 72]
    1. Jacobson NS, Truax P. Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12–19.
    1. McCraty R, Atkinson M, Tomasino D. Impact of a workplace stress reduction program on blood pressure and emotional health in hypertensive employees. J Altern Complement Med. 2003;9:355–369. doi: 10.1089/107555303765551589.
    1. Kotsou I, Nelis D, Grégoire J, Mikolajczak M. Emotional plasticity: Conditions and effects of improving emotional competence in adulthood. J Appl Psychol. 2011;96:827–839.
    1. Ciarrochi J, Scott G. The link between emotional competence and well-being: a longitudinal study. Brit J Guid Couns. 2006;34:231–243. doi: 10.1080/03069880600583287.
    1. Ciarrochi J, Deane FP, Anderson S. Emotional intelligence moderates the relationship between stress and mental health. Pers Indiv Differ. 2002;32:197–209. doi: 10.1016/S0191-8869(01)00012-5.
    1. Sonnentag S, Binnewies C, Mojza EJ. Staying well and engaged when demands are high: The role of psychological detachment. J Appl Psychol. 2010;95:965–976.
    1. Berset M, Elfering A, Lüthy S, Lüthi S, Semmer NK. Work stressors and impaired sleep: rumination as a mediator. Stress and Health. 2011;27:e71–e82. doi: 10.1002/smi.1337.
    1. Semmer NK, Grebner S, Elfering A. Research in Occupational Stress and Well-being. Bingley: Emerald (MCB UP); 2003. Beyond self-report: Using observational, physiological, and situation-based measures in research on occupational stress; pp. 205–263.
    1. Cuijpers P, Donker T, van Straten A, Li J, Andersson G. Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychol Med. 2010;40:1943–1957. doi: 10.1017/S0033291710000772.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir