Top

BMC Psychiatry

Published in:

Open Access 01-12-2013 | Study protocol

Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial

Authors: Anna S Geraedts, Annet M Kleiboer, Noortje M Wiezer, Willem van Mechelen, Pim Cuijpers

Published in: BMC Psychiatry | Issue 1/2013

Abstract

Background

Depressive disorders are highly prevalent in the working population and are associated with excessive costs for both society and companies. Effective treatment for employees with depressive symptoms in occupational health care is limited. The purpose of this study is to investigate the effectiveness and cost-effectiveness of an indicated preventive web-based guided self-help course for employees with depressive symptoms.

Methods

The study is a two-arm randomized controlled trial comparing a web-based guided self-help course with care-as-usual. The self-help course consists of 6 weekly lessons. Weekly support will be provided by a coach via the website. Subjects in the care-as-usual group do not receive any treatment in addition to regular care. 200 white collar workers from several national and international companies in the Netherlands will be recruited via different methods such as banners on the company’s intranet, pamphlets and posters. Subjects will be included when they: have elevated depressive symptoms (score ≥16 on the Center for Epidemiologic Studies Depression scale), are 18 years of age or older, have access to the Internet and can be contacted via e-mail. Exclusion criteria are: partial or full work absenteeism, a legal labor dispute with the employer and receiving treatment from the company’s occupational health care at study entrance.

The primary outcome is depressive symptoms. Secondary outcomes include work absenteeism, work performance, burnout, anxiety, quality of life, health care use and production losses. Outcome data will be collected at 8 weeks, 6 months, and 12 months after baseline. Analyses will be based on the intention-to-treat principle. The cost-effectiveness analyses will be performed from a societal and a company’s perspective. A process evaluation will be conducted alongside the study.

Discussion

This study evaluates the effectiveness and cost-effectiveness of a web-based guided self-help course for employees with depressive symptoms. This study could stimulate the use of e-mental health interventions in the worksite setting.

Trial registration

Nederlands Trial Register (NTR): TC2993

Available only for authorised users

Kessler RC, McGonagle KA, Zhao S, Nelson CB, Hughes M, Eshleman S, Wittchen HU, Kendler KS: Lifetime and 12-month prevalence of DSM-III-R psychiatric disorders in the United States: results from the National Comorbidity Survey. Arch Gen Psychiatry. 1994, 51: 8-19. 10.1001/archpsyc.1994.03950010008002.CrossRefPubMed

Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lépine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martínez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacín C, Romera B, Taub N, Vollebergh WA: ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project: Prevalence of mental disorders in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand. 2004, 109: 21-27.CrossRef

Waraich P, Goldner EM, Somers JM, Hsu L: Prevalence and incidence studies of mood disorders: a systematic review of the literature. Can J Psychiatry. 2004, 49: 124-138.PubMed

Wang JL, Adair CE, Patten SB: Mental health and related disability among workers: A population-based study. American Journal of Industrial Medicine. 2006, 49: 514-522. 10.1002/ajim.20319.CrossRefPubMed

OECD: Sick on the job?: Myths and realities about mental health and work. 2012, OECD Publishing: Mental health and work

Berto P, D’Ilario D, Ruffo P, Di Virgilio RF: Depression: cost-of illness studies in the international literature: a review. J Ment Health Policy Econ. 2000, 3: 3-10. 10.1002/1099-176X(200003)3:1<3::AID-MHP68>3.0.CO;2-H.CrossRefPubMed

Greenberg PE, Birnbaum HG: The economic burden of depression in the US: societal and patient perspectives. Exp Opin Pharmacother. 2005, 6: 369-376. 10.1517/14656566.6.3.369.CrossRef

Bijl RV, Ravelli A, van Zessen G: Prevalence of psychiatric disorders in the general population: results of the Netherlands Mental Health Survey and Incidence Study (NEMESIS). Soc Psychiatry Psychiatr Edpidemiol. 1998, 33: 587-595. 10.1007/s001270050098.CrossRef

Laitinen-Krispijn S: Bijl RV: Mental disorders and employee sickness absence: the NEMESIS study. Netherlands Mental Health Survey and Incidence Study. Soc Psychiatry Psychiatr Epidemiol. 2000, 35: 71-77.CrossRefPubMed

10.

de Graaf R, Tuithof M, van Dorsselaer S, ten Have M: Verzuim door psychische en somatische aandoeningen bij werkenden. 2011, Trimbos-Instituut: Resulaten van de ‘Netherlands Mental Health Survey and Incidence Study-2’ (NEMESIS-2). Utrecht, [in Dutch]

11.

Smit F, Cuijpers P, Oostenbrink J, Batelaan N, de Graaf R, Beekman A: Excess costs of common mental disorders: population based cohort study. J Ment Health Policy Econ. 2006, 9: 193-200.PubMed

12.

Cuijpers P, Smit F, Oostenbrink J, de Graaf R, ten Have M, Beekman A: Economic costs of minor depression: a population-based study. Acta Psychiatr Scand. 2007, 115: 229-236. 10.1111/j.1600-0447.2006.00851.x.CrossRefPubMed

13.

UWV: Costs of disability benefits in 2004, defined by ICD-10 diagnoses. 2005, UWV (Workers Insurance Authority), [in Dutch]

14.

NKAP: Factsheet 2, Facts and figures about work incapacity due to mental health disorders. 2004, NKAP (Dutch Knowledge Centre of Work and Mind): Utrecht, [in Dutch]

15.

Thomas CM, Morris S: Cost of depression among adults in England in 2000. Br J Psychiatry. 2003, 183: 514-519. 10.1192/bjp.183.6.514.CrossRefPubMed

16.

Lerner D, Henke RD: What does research tell us about depression, job performance, and work productivity?. J Occup Environ Med. 2008, 50: 401-410. 10.1097/JOM.0b013e31816bae50.CrossRefPubMed

17.

Lexis MA, Jansen NW, van Amelsvoort LG, van den Brandt PA, Kant I: Depressive complaints as a predictor of sickness absence among the working population. J Occup Environ Med. 2009, 51: 887-895. 10.1097/JOM.0b013e3181aa012a.CrossRefPubMed

18.

Stansfeld S, Feeney A, Head J, Canner R, North F, Marmot MG: Sickness absence for psychiatric illness: the Whitehall II Study. Soc Sci Med. 1995, 40: 189-197. 10.1016/0277-9536(94)E0064-Y.CrossRefPubMed

19.

Lexis MA, Jansen NW, Huibers MJ, van Amelsvoort LPMG, Berkouwer A, Ton GTA, van den Brandt PA, Kant I: Prevention of long-term sickness absence and major depression in high-risk employees: a randomised controlled trial. Occup Environ Med. 2011, 68: 400-407. 10.1136/oem.2010.057877.CrossRefPubMed

20.

National Mental Health Association USA Mental health facts: 2004, [http://www.nmha.org]

21.

Henderson M, Glozier N, Elliott KH: Long term sickness absence is caused by common conditions and needs managing. BMJ. 2005, 330: 802-803. 10.1136/bmj.330.7495.802.CrossRefPubMedPubMedCentral

22.

Cuijpers P, Dekker J, Hollon SD, Andersson G: Adding Psychotherapy to pharmacotherapy in the treatment of depressive disorders in adults: A meta-analysis. J of Clin Psychiatry. 2009, 70: 1219-1229. 10.4088/JCP.09r05021.CrossRef

23.

Dobson KS: A meta-analysis of the efficacy of cognitive therapy for depression. J of Cons and Clin Psychology. 1989, 57: 414-419.CrossRef

24.

Pinquart M, Duberstein PR, Lyness JM: Treatments for later-life depressive conditions: A meta-analytic comparison of pharmacotherapy and psychotherapy. Am J Psychiatry. 2006, 163: 1493-1501. 10.1176/appi.ajp.163.9.1493.CrossRefPubMed

25.

Churchill R, Hunot V, Corney R, Knapp M, McGuire H, Tylee A, Vessely S: A systematic review of controlled trials of the effectiveness and cost-effectiveness of brief psychological treatments for depression. Health Technol Assess. 2001, 5 (35):

26.

Andersson G, Cuijpers P: Internet-based and other computerized psychological treatments for adults depression: A meta-analysis. Cog Beh Therapy. 2009, 38: 196-205. 10.1080/16506070903318960.CrossRef

27.

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: 319-328. 10.1017/S0033291706008944.CrossRefPubMed

28.

van’t Hof E, Cuijpers P, Stein DJ: Self-help and Internet-guided interventions in depression and anxiety disorders: a systematic review of meta-analyses. CNS Spectr. 2009, 14: 34-40.PubMed

29.

Warmerdam L, van Straten A, Twisk J, Riper H, Cuijpers P: Internet-based treatment for adults with depressive symptoms: randomized controlled trial. J Med Internet Res. 2008, 10: e44-10.2196/jmir.1094.CrossRefPubMedPubMedCentral

30.

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: e7-10.2196/jmir.954.CrossRefPubMedPubMedCentral

31.

Nieuwenhuijsen K, Bültmann U, Neumeyer-Gromen A, Verhoeven AC, Verbeek JH, Feltz-Cornelis CM: Interventions to improve occupational health in depressed people. Cochrane Database Syst Rev. 2008, 2: CD006237-PubMed

32.

van der Klink J: Management of mental health problems of workers by occupational physicians. 2007, Utrecht: NVAB [Netherlands Society of Occupational physicians]

33.

van der Klink JJL, Blonk RWB, Schene AH, van Dijk FJH: Reducing long term sickness absence by an activating intervention in adjustment disorders: a cluster randomized controlled design. Occup Environ Med. 2003, 60: 429-437. 10.1136/oem.60.6.429.CrossRefPubMedPubMedCentral

34.

Blonk RWB, Brenninkmeijer V, Lagerveld SE, Houtman ILD: Return to work: a comparison of two cognitive behavioural interventions in cases of work-related psychological complaints among the self-employed. Work & Stress. 2006, 20: 129-144. 10.1080/02678370600856615.CrossRef

35.

Schene AH, Koeter MWJ, Kikkert MJ, Swinkels JA, McCrone P: Adjuvant occupational therapy for work-related major depression works: randomized trial including economic evaluation. Psychol Med. 2007, 37: 351-362. 10.1017/S0033291706009366.CrossRefPubMed

36.

Rebergen DS, Bruinvels DJ, Bezemer PD, van der Beek AJ, van Mechelen W: Guideline-based care of common mental disorders by occupational physicians (CO-OOP study): a randomized controlled trial. J Occup Environ Med. 2009, 51: 305-312. 10.1097/JOM.0b013e3181990d32.CrossRefPubMed

37.

Lexis MAS, Jansen NWH, Huibers MJH, van Amelsvoort LGPM, Berkouwer A, Tjin A, Ton G, van den Brandt PA, Kant IJ: Prevention of long-term sickness absence and major depression in high-risk employees: a randomised controlled trial. Occup Environ Med. 2011, 68: 400-407. 10.1136/oem.2010.057877.CrossRefPubMed

38.

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: 290-303. 10.1186/1471-2458-11-290.CrossRefPubMedPubMedCentral

39.

Eysenbach G: CONSORT-EHEALTH: Improving and Standardizing Reports of Web-based and Mobile Health Interventions. J Med Internet Res. 2011, 13: e126-10.2196/jmir.1923.CrossRefPubMedPubMedCentral

40.

Bowman D, Scogin F, Lyrene B: The efficacy of Self-Examination Therapy and Cognitive Bibliotherapy in the treatment of mild to moderate depression. Psychotherapy Research. 1995, 5: 131-140. 10.1080/10503309512331331256.CrossRef

41.

Beck AT, Rush AJ, Shaw BF, Emery G: Cognitive therapy of depression. 1979, New York: Guilford Press

42.

Franck E, Wiezer N: Ervaringen met de Preventie Leidraad. 2004, Hoofddorp: TNO, [in Dutch]

43.

Franck E, Wiezer N: Handleiding Preventie Leidraad. 2004, Hoofddorp: TNO, [in Dutch]

44.

Bouma J, Ranchor AV, Sanderman R, van Sonderen E: Assessment of symptoms of depression by means of the CES-D: A manual. 1995, Groningen: Stichting Drukkerij Regenboog

45.

Furukawa T, Hirai T, Kitamura T, Takahashi K: Application of the Center for Epidemiologic Studies Depression Scale among first-visit psychiatric patients: a new approach to improve its performance. J Affect Disord. 1997, 46: 1-13. 10.1016/S0165-0327(97)00079-7.CrossRefPubMed

46.

Haringsma R, Engels GI, Beekman AT, Spinhoven P: The criterion validity of the Center for Epidemiological Studies Depression Scale (CES-D) in a sample of self-referred elders with depressive symptomatology. Int J Geriatr Psychiatry. 2004, 19: 558-563. 10.1002/gps.1130.CrossRefPubMed

47.

Yang HJ, Soong WT, Kuo PH, Chang HL, Chen WJ: Using the CESD in a two-phase survey for depressive disorders among nonreferred adolescents in Taipei: a stratum-specific likelihood ratio analysis. J Affect Disord. 2004, 82: 419-430.PubMed

48.

Kessler R, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P: The World Health Organization health and work performance questionnaire (HPQ). J Occup Environ Med. 2003, 45: 156-174. 10.1097/01.jom.0000052967.43131.51.CrossRefPubMed

49.

Kessler RC, Ames M, Hymel PA, Loeppke R, McKenas DK, Richling DE, Stang PE, Ustun TD: Using the World Health Organization Health and Work Performance Questionnaire (HPQ) to evaluate the indirect workplace costs of illness. J Occup Environ Med. 2004, 46: 23-37. 10.1097/01.jom.0000126683.75201.c5.CrossRef

50.

Maslach C, Jackson SE, Leiter MP: Maslach Burnout Inventory manual. 1996, Palo Alto, California: Consulting Psychologist’s Press, 3

51.

Schaufeli WB, Van Dierendonck D: UBOS, Utrechtse Burnout Schaal. 2000, Lisse: Swets Test Publishers

52.

Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983, 67: 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed

53.

Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM: A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997, 27: 363-370. 10.1017/S0033291796004382.CrossRefPubMed

54.

Group EQ: Euroqol – a new facility for the measurement of health related quality of life. Health Policy. 1990, 16: 199-208.CrossRef

55.

Lamers LM, Stalmeier PFM, McDonnell J, Krabbe PFM, van Busschbach JJ: Kwaliteit van leven meten in economische evaluaties: het Nederlands EQ-5D-tarief. Nederlands Tijdschrift voor Geneeskunde. 2005, 149: 1574-1578.PubMed

56.

Hakkaart-van Roijen L, van Straten A, Donker M, Tiemans B: Manual Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). 2002, Rotterdam: Institute for Medical Technology Assessment

57.

van den Brink M, van den Hout WB, Stiggelbout AM, Putter H, van de Velder CJH, Kievit J: Self reports of health-care utilization: Diary or questionnaire?. Int J Technol Assess Health Care. 2005, 21: 298-304.CrossRefPubMed

58.

World Health Organization: Composite International Diagnostic Interview (CIDI). 1990, Geneva: WHO

59.

American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV). 2001, Washington, American Psychiatric Association

60.

Warmerdam L, van Straten A, Jongsma J, Twisk J, Cuijpers P: Online cognitive behavioral therapy and problem-solving therapy for depressive symptoms: exploring mechanisms of change. J Behav Ther & Exp Psychiat. 2010, 41: 64-70. 10.1016/j.jbtep.2009.10.003.CrossRef

61.

Stansfeld S, Candy B: Psychosocial work environment and mental health- a meta-analytic review. Scan J Work Environ Health. 2006, 32 (6): 443-462. 10.5271/sjweh.1050.CrossRef

62.

Peirce RS, Frone MR, Russell M, Cooper ML, Mudar P: A longitudinal model of social contact, social support, depression and alcohol use. Health Psychology. 2000, 19 (1): 28-38.CrossRefPubMed

63.

Plaisier I, de Bruijn JGM, de Graaf R, ten Have M, Beekman ATF, Penninx BWJH: The contribution of working conditions and social support to the onset of depressive and anxiety disorders among male and female employees. Social Science & Medicine. 2007, 64: 401-410. 10.1016/j.socscimed.2006.09.008.CrossRef

64.

Pearlin LI, Schooler C: The Structure of coping. J Health Soc Behav. 1978, 19: 2-21. 10.2307/2136319.CrossRefPubMed

65.

van den Bossche SNJ, Smulders PGW: The Netherlands Working Conditions Survey 2003. 2004, TNO Work and Employment: Methodology and overall results. Hoofddorp, [in Dutch]

66.

Karasek RA: Job content questionnaire and user’s guide. 1985, University of Massachusetts Lowell, Department of Work Environment: Lowell

67.

Houtman I, Goudswaard A, Dhondt S, Van der Grinten M, Hildebrandt V, Kompier M: Evaluation study on stress and physical load. 1995, Den Haag: VUGA, [in Dutch]

68.

Ritterband LM, Ardalan K, Thorndike FP, Magee JC, Saylor DK, Cox DJ, Sutphen JL, Borowitz SM: Real World Use of an Internet Intervention for Pediatric Encopresis. J Med Internet Res. 2008, 10: 2-10.2196/jmir.963.CrossRef

69.

Linnan L, Steckler A, In Process Evaluation for Public Health Interventions and Research: Process evaluation for public health interventions and research: an overview. 2002, San Francisco: Jossey-Bass: Edited by Steckler A & Linnan L, 1-24.

70.

Cohen J: Statistical Power Analysis for the Behavioral Sciences 2nd edition. 1988, Hillsdale, New Jersey: Erlbaum

71.

Jacobson NS, Truax P: Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991, 59: 12-19.CrossRefPubMed

72.

MacKinnon DP, In Scientific methods in prevention research: Analysis of mediating variables in prevention and intervention research. 1994, Washington DC: U. S. Government Printing Office: Edited by Cazares A & Beatty LA, 127-153.

73.

Thompson SG, Barber JA: How should cost data in pragmatic randomised trials be analysed?. BMJ. 2000, 320: 1197-11200. 10.1136/bmj.320.7243.1197.CrossRefPubMedPubMedCentral

74.

Fenwick E, O'Brien BJ, Briggs A: Cost-effectiveness acceptability curves–facts, fallacies and frequently asked questions. Health Econ. 2004, 13: 405-415. 10.1002/hec.903.CrossRefPubMed

75.

Uegaki K: Economic evaluation of interventions for occupational health. 2009, PhD-thesis. Vrije University Amsterdam, Department of Medicine: Exploring methods & applied studies

The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-244X/13/61/prepub

Title: Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial
Authors: Anna S Geraedts
Annet M Kleiboer
Noortje M Wiezer
Willem van Mechelen
Pim Cuijpers
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2013
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/1471-244X-13-61

At a glance: The STEP trials

Springer Medicine

Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2013

Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial

Prevalence and factors associated with probable HIV dementia in an African population: A cross-sectional study of an HIV/AIDS clinic population

Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial

Transition to adult mental health services for young people with Attention Deficit/Hyperactivity Disorder (ADHD): a qualitative analysis of their experiences

A three generation study of the mental health relationships between grandparents, parents and children

Protocol for a collaborative meta-analysis of 5-HTTLPR, stress, and depression