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

BackgroundWork-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.MethodsThe 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.DiscussionThe 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 registrationGerman Register of Clinical Studies (DRKS): DRKS00004749

[1]  A. Lange,et al.  ‘Interapy’ Burn-out: Prävention und Behandlung von Burn-out über das Internet , 2004, Verhaltenstherapie.

[2]  Sabine Sonnentag,et al.  Staying well and engaged when demands are high: the role of psychological detachment. , 2010, The Journal of applied psychology.

[3]  M. Kivimäki,et al.  Work stress in the etiology of coronary heart disease--a meta-analysis. , 2006, Scandinavian journal of work, environment & health.

[4]  Yves Hänggi.  Kann web-basierte Stressprävention erfolgreich sein? , 2006 .

[5]  G. Andrews,et al.  Internet-Based Course for the Management of Stress for Junior High Schools , 2009, The Australian and New Zealand journal of psychiatry.

[6]  F. Deane,et al.  Emotional intelligence moderates the relationship between stress and mental health , 2002 .

[7]  P. Grime,et al.  Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism. , 2004, Occupational medicine.

[8]  F. Petermann.  Hospital Anxiety and Depression Scale, Deutsche Version (HADS-D) , 2011 .

[9]  Gerhard Andersson,et al.  Randomized Controlled Trial of Internet-Based Stress Management , 2003, Cognitive behaviour therapy.

[10]  B. Klein,et al.  The Impact of Online Resilience Training for Sales Managers on Wellbeing and Work Performance , 2009 .

[11]  C. Krauth.  Cost Estimation Methods in Health Economic Evaluation , 2010 .

[12]  Katherine M. Richardson,et al.  Effects of occupational stress management intervention programs: a meta-analysis. , 2008, Journal of occupational health psychology.

[13]  R. Blonk,et al.  The benefits of interventions for work-related stress. , 2001, American journal of public health.

[14]  Matthias Berking,et al.  Emotion regulation and mental health: recent findings, current challenges, and future directions , 2012, Current opinion in psychiatry.

[15]  S. Stansfeld,et al.  Psychosocial work environment and mental health--a meta-analytic review. , 2006, Scandinavian journal of work, environment & health.

[16]  P. Cuijpers,et al.  Guided self-help on the internet for turkish migrants with depression: the design of a randomized controlled trial , 2010, Trials.

[17]  P. Cuijpers,et al.  Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial , 2013, BMC Psychiatry.

[18]  Morten Wahrendorf,et al.  A short generic measure of work stress in the era of globalization: effort–reward imbalance , 2009, International archives of occupational and environmental health.

[19]  Joanne C. Carey,et al.  An online family intervention to reduce parental distress following pediatric brain injury. , 2006, Journal of consulting and clinical psychology.

[20]  Norito Kawakami,et al.  Effects of Web‐Based Psychoeducation on Self‐Efficacy, Problem Solving Behavior, Stress Responses and Job Satisfaction among Workers: A Controlled Clinical Trial , 2005, Journal of occupational health.

[21]  B. Neubach,et al.  Gütekriterien einer deutschen Fassung des Maslach Burnout Inventory (MBI—D)—Eine Replikationsstudie bei Altenpflegekräften. , 2000 .

[22]  undefined Eurofound.  Third European survey on working conditions 2000 , 2011 .

[23]  S. Folkman,et al.  Stress, Appraisal, and Coping. New York, NY: Springer; , 1984 .

[24]  Heleen Riper,et al.  Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis , 2006, Psychological Medicine.

[25]  A. Farina,et al.  Attitudes toward Seeking Professional Psychological Help: A Shortened Form and Considerations for Research. , 1995 .

[26]  M. Hautzinger,et al.  Allgemeine Depressions Skala , 1993 .

[27]  J Li,et al.  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 , 2010, Psychological Medicine.

[28]  P. Cuijpers,et al.  Emotion Regulation Skills Training Enhances the Efficacy of Inpatient Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized Controlled Trial , 2013, Psychotherapy and Psychosomatics.

[29]  Robert Karasek,et al.  Job decision latitude and mental strain: Implications for job redesign , 1979 .

[30]  Achim Elfering,et al.  Work stressors and impaired sleep: rumination as a mediator. , 2011, Stress and health : journal of the International Society for the Investigation of Stress.

[31]  C. Krauth.  Methoden der Kostenbestimmung in der gesundheitsökonomischen Evaluation , 2010 .

[32]  John P Trougakos,et al.  Momentary work recovery: The role of within-day work breaks , 2009 .

[33]  N. Jacobson,et al.  Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. , 1991, Journal of consulting and clinical psychology.

[34]  J. Ciarrochi,et al.  The link between emotional competence and well-being: a longitudinal study , 2006 .

[35]  D. Rubin,et al.  Statistical Analysis with Missing Data. , 1989 .

[36]  R. Cook,et al.  A Field Test of a Web-Based Workplace Health Promotion Program to Improve Dietary Practices, Reduce Stress, and Increase Physical Activity: Randomized Controlled Trial , 2007, Journal of medical Internet research.

[37]  A. Williams.  EuroQol : a new facility for the measurement of health-related quality of life , 1990 .

[38]  C. Morin,et al.  The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. , 2011, Sleep.

[39]  G. Huston.  The Hospital Anxiety and Depression Scale. , 1987, The Journal of rheumatology.

[40]  Pål Kraft,et al.  Multilevel Growth Curve Analyses of Treatment Effects of a Web-Based Intervention for Stress Reduction: Randomized Controlled Trial , 2013, Journal of medical Internet research.

[41]  Joshua C. Magee,et al.  Validation of the Insomnia Severity Index as a Web-Based Measure , 2011, Behavioral sleep medicine.

[42]  G. Eysenbach.  CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions , 2011, Journal of medical Internet research.

[43]  Gerhard Andersson,et al.  Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial , 2009, Trials.

[44]  Keith S. Dobson,et al.  Handbook of cognitive-behavioral therapies , 2009 .

[45]  Pim Cuijpers,et al.  Effectiveness of a Web-Based Self-Help Intervention for Symptoms of Depression, Anxiety, and Stress: Randomized Controlled Trial , 2008, Journal of medical Internet research.

[46]  S. Sonnentag,et al.  The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. , 2007, Journal of occupational health psychology.

[47]  Delphine Nélis,et al.  Emotional plasticity: conditions and effects of improving emotional competence in adulthood. , 2011, The Journal of applied psychology.

[48]  J. Ruwaard,et al.  E‐Mailed Standardized Cognitive Behavioural Treatment of Work‐Related Stress: A Randomized Controlled Trial , 2007, Cognitive behaviour therapy.

[49]  P. Areán.  Problem-solving Therapy , 2009 .

[50]  L. Roijen,et al.  Manual Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness , 2002 .

[51]  R. Cook,et al.  A Web-Based Approach to Managing Stress and Mood Disorders in the Workforce , 2008, Journal of occupational and environmental medicine.

[52]  Sheldon Cohen,et al.  Who's Stressed? Distributions of Psychological Stress in the United States in Probability Samples from 1983, 2006, and 2009 , 2012 .

[53]  A. Kasuya.  EuroQol--a new facility for the measurement of health-related quality of life. , 1990, Health policy.

[54]  A. Seidler,et al.  The role of psychosocial stress at work for the development of cardiovascular diseases: a systematic review , 2011, International Archives of Occupational and Environmental Health.

[55]  W. Wittmann,et al.  [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. , 1989, Psychotherapie, Psychosomatik, medizinische Psychologie.

[56]  Katherine Pollak Eisen,et al.  Stress management in the workplace: A comparison of a computer-based and an in-person stress-management intervention , 2008, Comput. Hum. Behav..

[57]  C. Morin,et al.  Validation of the Insomnia Severity Index as an outcome measure for insomnia research. , 2001, Sleep medicine.

[58]  Josh M Cisler,et al.  Emotion Regulation and Anxiety Disorders , 2012, Current Psychiatry Reports.

[59]  Peter Bajorski,et al.  Wiley Series in Probability and Statistics , 2010 .

[60]  L. Radloff.  The CES-D Scale , 1977 .

[61]  Nicole A. Lazar,et al.  Statistical Analysis With Missing Data , 2003, Technometrics.

[62]  B. Arnetz,et al.  Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861] , 2005, BMC public health.

[63]  J. Stöber,et al.  Weekly assessment of worry: an adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. , 1998, Behaviour research and therapy.

[64]  J. Siegrist.  Reciprocity in basic social exchange and health: can we reconcile person-based with population-based psychosomatic research? , 1998, Journal of Psychosomatic Research.

[65]  Charles M. Morin,et al.  Insomnia: Psychological Assessment and Management , 1993 .

[66]  S. Berjot,et al.  Psychometric properties of the French versions of the Perceived Stress Scale , 2012, International journal of occupational medicine and environmental health.

[67]  A. Michalsen,et al.  Iyengar Yoga for Distressed Women: A 3-Armed Randomized Controlled Trial , 2012, Evidence-based complementary and alternative medicine : eCAM.

[68]  Torbjörn Akerstedt,et al.  Psychosocial stress and impaired sleep. , 2006, Scandinavian journal of work, environment & health.

[69]  J. Gross,et al.  Emotion regulation and vulnerability to depression: spontaneous versus instructed use of emotion suppression and reappraisal. , 2010, Emotion.

[70]  O. Christ,et al.  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]. Diagnostica, , . (IF: 0.91)* , 2013 .

[71]  Sheldon Cohen,et al.  Who ’ s Stressed ? Distributions of Psychological Stress in the United States in Probability Samples from 1983 , 2006 , and 20091 S , 2012 .

[72]  J. Williams,et al.  Mindfulness online: a preliminary evaluation of the feasibility of a web-based mindfulness course and the impact on stress , 2012, BMJ Open.

[73]  N. Semmer,et al.  BEYOND SELF-REPORT: USING OBSERVATIONAL, PHYSIOLOGICAL, AND SITUATION-BASED MEASURES IN RESEARCH ON OCCUPATIONAL STRESS , 2003 .

[74]  J. Stöber,et al.  Penn State Worry Questionnaire-Past Week , 2013 .

[75]  A. Katsarou,et al.  A GLOBAL MEASURE OF PERCEIVED STRESS , 2012 .

[76]  T J Meyer,et al.  Development and validation of the Penn State Worry Questionnaire. , 1990, Behaviour research and therapy.

[77]  Sarah Lord,et al.  MyStudentBody–Stress: An Online Stress Management Intervention for College Students , 2008, Journal of health communication.

[78]  Richie Poulton,et al.  Work stress precipitates depression and anxiety in young, working women and men , 2007, Psychological Medicine.

[79]  A. Bakker,et al.  The Measurement of Engagement and Burnout: A Two Sample Confirmatory Factor Analytic Approach , 2002 .

[80]  David E. Booth,et al.  Analysis of Incomplete Multivariate Data , 2000, Technometrics.

[81]  B. Wiegand,et al.  Efficacy of a comprehensive program for reducing stress in women: A prospective, randomized trial , 2010, Current medical research and opinion.

[82]  D. Schulte.  Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV) , 2005 .

[83]  O. Christ,et al.  Entwicklung und Validierung eines Fragebogens zur emotionsspezifischen Selbsteinschätzung emotionaler Kompetenzen (SEK-ES) , 2013 .

[84]  A. Nezu,et al.  Problem-Solving Therapy , 2002 .

[85]  増田 真也,et al.  バーンアウト測定尺度 Maslach Burnout Inventory-General Survey(MBI-GS)の概要と日本版について , 2011 .

[86]  J. Sluiter,et al.  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 , 2011, BMC public health.

[87]  Rollin McCraty,et al.  Impact of a workplace stress reduction program on blood pressure and emotional health in hypertensive employees. , 2003, Journal of alternative and complementary medicine.

[88]  T. Brown,et al.  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. , 2008, Behaviour research and therapy.

[89]  Douglas G Altman,et al.  Better reporting of randomised controlled trials: the CONSORT statement , 1996, BMJ.

[90]  G. Valacchi,et al.  Alternative Pathways of Cancer Cell Death by Rottlerin: Apoptosis versus Autophagy , 2012, Evidence-based complementary and alternative medicine : eCAM.

[91]  J. Ware,et al.  A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. , 1996, Medical care.

[92]  R. Zwick,et al.  The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. , 1982, Evaluation and program planning.

[93]  M. Kornitzer,et al.  Occupational stress and incidence of sick leave in the Belgian workforce: the Belstress study , 2004, Journal of Epidemiology and Community Health.

[94]  Susan A. Murphy,et al.  Monographs on statistics and applied probability , 1990 .

[95]  Alireza Ahmadvand.  CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions , 2011 .

[96]  S. Folkman,et al.  Stress, appraisal, and coping , 1974 .

[97]  K. Proper,et al.  Worksite mental health interventions: a systematic review of economic evaluations , 2012, Occupational and Environmental Medicine.

[98]  V. Starcevic,et al.  Preliminary validation of an ultra-brief version of the Penn State Worry Questionnaire. , 2011, Clinical psychology & psychotherapy.

[99]  H. Znoj,et al.  Entwicklung und Validierung eines Fragebogens zur standardisierten Selbsteinschätzung emotionaler Kompetenzen (SEK-27) , 2008 .

[100]  A. Väänänen,et al.  Occupational burnout and chronic work disability: an eight-year cohort study on pensioning among Finnish forest industry workers. , 2009, Journal of affective disorders.

[101]  Matthias Berking,et al.  Enhancing emotion-regulation skills in police officers: results of a pilot controlled study. , 2010, Behavior therapy.