Skip to main content
Top
Published in: BMC Public Health 1/2013

Open Access 01-12-2013 | Study protocol

Effectiveness of a minimal psychological intervention to reduce mild to moderate depression and chronic fatigue in a working population: the design of a randomized controlled trial

Authors: Ed Aelfers, Hans Bosma, Inge Houkes, Jacques ThM van Eijk

Published in: BMC Public Health | Issue 1/2013

Login to get access

Abstract

Background

In a working population, common mental complaints like depressed mood and chronic fatigue are highly prevalent and often result in further deterioration of mental health and consequently absence from work. In a large occupational health setting, we will evaluate the (cost-) effectiveness of a Minimal Psychological Intervention (MPI), in reducing symptoms of depression and chronic fatigue in a working population. The MPI is also evaluated regarding its appreciation by worker, nurse, and occupational health physician (process evaluation). The tailor-made intervention is administered by nurses, who are trained in the principles of cognitive behavioural therapy and self-management.

Methods/design

The presented WoPaCoM study (Work Participation of Workers with Common Mental complaints) is a two-armed randomized controlled trial, comparing MPI with usual care. A total number of 124 workers suffering from (chronic) mental fatigue or mild to moderate depression will be included. A stratified and block randomization will be applied, stratifying by customer organisation, income, and gender, using a block size of four. It will include a baseline measurement and subsequently follow up measurements after 4, 6 and 12 months. The primary outcome measures are symptoms of either fatigue (using the Checklist Individual Strength) and/or depression (using the Beck Depression Inventory) and secondary outcome measures include sickness absence, self efficacy, costs and quality of life. Analysis will include both univariate and multivariate techniques and data will be analysed according to the intention to treat principle.

Discussion

Patient recruitment in an occupational setting proves to be complicated and time consuming. Shift work for instance proved to be an obstacle for making appointments for consultation with the nurse. Furthermore, economic developments might have created job insecurity which negatively influenced participation in the study, with workers being anxious to be detected as having psychological problems. Additionally, long-term follow-up in a working population is time-consuming and continuously engages occupational health staff and administrative personnel to control the process of data gathering. However, if the intervention proves to be effective, occupational medicine will have a manageable option for treatment of workers who are at risk of loss of productivity or sickness absence.

Trial registration

Nederlands Trialregister NTR3162
Appendix
Available only for authorised users
Literature
1.
go back to reference Bültmann U, Kant IJ, Kasl SV, Beurskens A, van den Brandt P: Fatigue and psychological distress in the working population Psychometrics, prevalence, and correlates. J Psychosom Res. 2002, 52: 445-452.CrossRefPubMed Bültmann U, Kant IJ, Kasl SV, Beurskens A, van den Brandt P: Fatigue and psychological distress in the working population Psychometrics, prevalence, and correlates. J Psychosom Res. 2002, 52: 445-452.CrossRefPubMed
3.
go back to reference Huibers M, Kant IJ, Swaen G, Kasl SV: Prevalence of chronic fatigue syndrome-like caseness in the working population: results from the Maastricht cohort study. Occup Environ Med. 2004, 61: 464-466.CrossRefPubMedPubMedCentral Huibers M, Kant IJ, Swaen G, Kasl SV: Prevalence of chronic fatigue syndrome-like caseness in the working population: results from the Maastricht cohort study. Occup Environ Med. 2004, 61: 464-466.CrossRefPubMedPubMedCentral
4.
go back to reference Jansen N, Huibers M, van Amelsvoort L, Kant IJ: Aetiology of prolonged fatigue among workers. An overview of findings from the Maastricht Cohort Study. Tijdschr Psychiatr. 2007, 49 (8): 537-545.PubMed Jansen N, Huibers M, van Amelsvoort L, Kant IJ: Aetiology of prolonged fatigue among workers. An overview of findings from the Maastricht Cohort Study. Tijdschr Psychiatr. 2007, 49 (8): 537-545.PubMed
5.
go back to reference Judith A, Ricci J, Chee E, Lorandeau A, Berger M: Fatigue in the U.S. Workforce: Prevalence and Implications for Lost Productive Work Time. JOEM. 2007, 49 (1): 1-10. Judith A, Ricci J, Chee E, Lorandeau A, Berger M: Fatigue in the U.S. Workforce: Prevalence and Implications for Lost Productive Work Time. JOEM. 2007, 49 (1): 1-10.
6.
go back to reference Janssen N, Kant IJ, Swaen G, Janssen P, Schröer P: Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work. Occup Environ Med. 2003, 60 (Suppl I): i71-i76.CrossRefPubMedPubMedCentral Janssen N, Kant IJ, Swaen G, Janssen P, Schröer P: Fatigue as a predictor of sickness absence: results from the Maastricht cohort study on fatigue at work. Occup Environ Med. 2003, 60 (Suppl I): i71-i76.CrossRefPubMedPubMedCentral
8.
go back to reference Swaen G, van Amelsvoort L, Bültmann , Kant IJ: Fatigue as a risk factor for being injured in an occupational accident: results from the Maastricht Cohort Study. Occup Environ Med. 2003, 60 ((Suppl I): i88-i92.CrossRefPubMedPubMedCentral Swaen G, van Amelsvoort L, Bültmann , Kant IJ: Fatigue as a risk factor for being injured in an occupational accident: results from the Maastricht Cohort Study. Occup Environ Med. 2003, 60 ((Suppl I): i88-i92.CrossRefPubMedPubMedCentral
9.
go back to reference Andrea H, Kant IJ, Beurskens A, Metsemakers J, van Schayck C: Associations between fatigue attributions and fatigue, health, and psychosocial work characteristics: a study among employees visiting a physician with fatigue. Occup Environ Med. 2003, 60 (Suppl I): i99-i104.CrossRefPubMedPubMedCentral Andrea H, Kant IJ, Beurskens A, Metsemakers J, van Schayck C: Associations between fatigue attributions and fatigue, health, and psychosocial work characteristics: a study among employees visiting a physician with fatigue. Occup Environ Med. 2003, 60 (Suppl I): i99-i104.CrossRefPubMedPubMedCentral
10.
go back to reference Huibers M, Leone S, Ludovic GPM, van Amelsvoort L, Kant IJ, Knottnerus J: Associations of fatigue and depression among fatigued employees over time: A 4-year follow-up study. J Psychosom Res. 2007, 63: 137-142.CrossRefPubMed Huibers M, Leone S, Ludovic GPM, van Amelsvoort L, Kant IJ, Knottnerus J: Associations of fatigue and depression among fatigued employees over time: A 4-year follow-up study. J Psychosom Res. 2007, 63: 137-142.CrossRefPubMed
11.
go back to reference Kant IJ, Jansen N, van Amelsvoort L, Huibers M: Beloop, consequenties en behandeling van langdurige vermoeidheid onder werknemers. Overzicht van bevindingen uit de Maastrichtse Cohort Studie. Tijdschr Psychiatr. 2007, 8: 547-554. Kant IJ, Jansen N, van Amelsvoort L, Huibers M: Beloop, consequenties en behandeling van langdurige vermoeidheid onder werknemers. Overzicht van bevindingen uit de Maastrichtse Cohort Studie. Tijdschr Psychiatr. 2007, 8: 547-554.
12.
go back to reference Jenkins R: Minor psychiatric morbidity in employed young men and women and its contribution to sickness absence. Br J Ind Med. 1985, 42: 147-154.PubMedPubMedCentral Jenkins R: Minor psychiatric morbidity in employed young men and women and its contribution to sickness absence. Br J Ind Med. 1985, 42: 147-154.PubMedPubMedCentral
13.
go back to reference Broadhead W, Blazer D, George L, Kit Tse C: Depression, disability days and days lost from work in a prospective epidemiologic survey. JAMA. 1990, 264: 2524-2528.CrossRefPubMed Broadhead W, Blazer D, George L, Kit Tse C: Depression, disability days and days lost from work in a prospective epidemiologic survey. JAMA. 1990, 264: 2524-2528.CrossRefPubMed
14.
go back to reference Laitinen-Krispijn S, van Bijl R: Mental disorders and employee sickness absence: the NEMESIS study. Soc Psychiatry Psychiatr Epidemiol. 2000, 35: 71-77.CrossRefPubMed Laitinen-Krispijn S, van Bijl R: Mental disorders and employee sickness absence: the NEMESIS study. Soc Psychiatry Psychiatr Epidemiol. 2000, 35: 71-77.CrossRefPubMed
15.
go back to reference Ackerman R, Williams J: Rational treatment choices for non-major depressions in primary care: an evidence based review. J Gen Intern Med. 2002, 17: 293-301.CrossRef Ackerman R, Williams J: Rational treatment choices for non-major depressions in primary care: an evidence based review. J Gen Intern Med. 2002, 17: 293-301.CrossRef
16.
17.
go back to reference National Institute for Clinical Excellence: Depression. Management of depression in primary and secondary care. 2004, London: NHS, Nice National Institute for Clinical Excellence: Depression. Management of depression in primary and secondary care. 2004, London: NHS, Nice
18.
go back to reference van Eijk J, Diederiks J, Kempen G, Honig A, van der Meer K, Brenninkmeijer W: Development and feasibility of a nurse administered strategy on depression in community-dwelling patients with a chronic physical disease. Patient Educ Couns. 2004, 54: 87-94.CrossRefPubMed van Eijk J, Diederiks J, Kempen G, Honig A, van der Meer K, Brenninkmeijer W: Development and feasibility of a nurse administered strategy on depression in community-dwelling patients with a chronic physical disease. Patient Educ Couns. 2004, 54: 87-94.CrossRefPubMed
19.
go back to reference Jonkers C, Lamers F, Bosma H, Metsemakers J, Kempen G, van Eijk J: Process evaluation of a minimal psychological intervention to reduce depression in chronically ill elderly persons. Patient Educ Couns. 2007, 68: 252-257.CrossRefPubMed Jonkers C, Lamers F, Bosma H, Metsemakers J, Kempen G, van Eijk J: Process evaluation of a minimal psychological intervention to reduce depression in chronically ill elderly persons. Patient Educ Couns. 2007, 68: 252-257.CrossRefPubMed
20.
go back to reference Lamers F, Jonkers C, Bosma H, Kempen G, Meijer J, Penninx B, Knottnerus A, van Eijk J: A Minimal Psychological Intervention in Chronically Ill Elderly Patients with Depression: A Randomized Trial. Psychother Psychosom. 2010, 79: 217-226.CrossRefPubMed Lamers F, Jonkers C, Bosma H, Kempen G, Meijer J, Penninx B, Knottnerus A, van Eijk J: A Minimal Psychological Intervention in Chronically Ill Elderly Patients with Depression: A Randomized Trial. Psychother Psychosom. 2010, 79: 217-226.CrossRefPubMed
21.
go back to reference Lamers F: Treating Depression in chronically ill elderly; The evaluation of a Minimal Psychological Intervention. Universitaire Pers Maastricht Lamers F: Treating Depression in chronically ill elderly; The evaluation of a Minimal Psychological Intervention. Universitaire Pers Maastricht
22.
go back to reference Lamers F, Jonkers C, Bosma H, Chavannes N, Knottnerus J, van Eijk J: Improving Quality of Life in Depressed COPD Patients: Effectiveness of a Minimal Psychological Intervention. COPD. 2010, 7: 315-322.CrossRefPubMed Lamers F, Jonkers C, Bosma H, Chavannes N, Knottnerus J, van Eijk J: Improving Quality of Life in Depressed COPD Patients: Effectiveness of a Minimal Psychological Intervention. COPD. 2010, 7: 315-322.CrossRefPubMed
23.
go back to reference Lamers F, Jonkers C, Bosma H, Chavannes N, Knottnerus J, van Eijk J: Treating depression in diabetes patients: does a nurse-administered minimal psychological intervention affect diabetes-specific quality of life and glycaemic control? A randomized controlled trial. J Adv Nurs. 2011,  -Blackwell Publishing Ltd (Accepted for publication 30 October 2010) Lamers F, Jonkers C, Bosma H, Chavannes N, Knottnerus J, van Eijk J: Treating depression in diabetes patients: does a nurse-administered minimal psychological intervention affect diabetes-specific quality of life and glycaemic control? A randomized controlled trial. J Adv Nurs. 2011,  -Blackwell Publishing Ltd (Accepted for publication 30 October 2010)
24.
go back to reference Makowiec-Dabrowska T, Koszada-Włodarczyk W: The CIS20R Questionnaire and its suitability for prolonged fatigue studies. Med Pr. 2006, 57 (4): 335-345.PubMed Makowiec-Dabrowska T, Koszada-Włodarczyk W: The CIS20R Questionnaire and its suitability for prolonged fatigue studies. Med Pr. 2006, 57 (4): 335-345.PubMed
25.
26.
go back to reference Bultmann U, de Vries M, Beurskens A, Bleijenberg G, Vercoulen J, Kant IJ: Measurement of prolonged fatigue in the working population: determination of a cutoff point for the checklist individual strength. J Occup Health Psychol. 2000, 5 (4): 411-416.CrossRefPubMed Bultmann U, de Vries M, Beurskens A, Bleijenberg G, Vercoulen J, Kant IJ: Measurement of prolonged fatigue in the working population: determination of a cutoff point for the checklist individual strength. J Occup Health Psychol. 2000, 5 (4): 411-416.CrossRefPubMed
28.
go back to reference Kroenke K, Spitzer R: The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiatr Ann. 2002, 32: 9-CrossRef Kroenke K, Spitzer R: The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiatr Ann. 2002, 32: 9-CrossRef
29.
go back to reference Spitzer R, Kroenke K, Williams J: Validation and Utility of a Self-report Version of PRIME-MD: The PHQ Primary Care Study. JAMA. 1999, 282 (18): 1737-1744.CrossRefPubMed Spitzer R, Kroenke K, Williams J: Validation and Utility of a Self-report Version of PRIME-MD: The PHQ Primary Care Study. JAMA. 1999, 282 (18): 1737-1744.CrossRefPubMed
30.
go back to reference Löwe B, Kroenke K, Herzog W, Gräfe K: Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004, 81: 61-66.CrossRefPubMed Löwe B, Kroenke K, Herzog W, Gräfe K: Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004, 81: 61-66.CrossRefPubMed
31.
go back to reference Löwe B, Unützer J, Callahan C, Perkins A, Kroenke K: Monitoring Depression Treatment Outcomes With the Patient Health Questionnaire-9. Med Care. 2004, 42 (12): 1194-1201.CrossRefPubMed Löwe B, Unützer J, Callahan C, Perkins A, Kroenke K: Monitoring Depression Treatment Outcomes With the Patient Health Questionnaire-9. Med Care. 2004, 42 (12): 1194-1201.CrossRefPubMed
32.
go back to reference American Psychiatric Association: DSM-IV-TR: Diagnostic and statistical manual of mental disorders. Fourth edition, text revision edition. 2000, Washington DC: American Psychiatric Association, 943-CrossRef American Psychiatric Association: DSM-IV-TR: Diagnostic and statistical manual of mental disorders. Fourth edition, text revision edition. 2000, Washington DC: American Psychiatric Association, 943-CrossRef
33.
go back to reference Lecrubier Y, Sheehan D, Weiller E, Amorim P, Bonora I, Sheehan K, Janavs J, Dunbar GC: The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997, 12: 224-231.CrossRef Lecrubier Y, Sheehan D, Weiller E, Amorim P, Bonora I, Sheehan K, Janavs J, Dunbar GC: The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997, 12: 224-231.CrossRef
34.
go back to reference Sheehan D, Lecrubier Y, Sheehan K, Janavs J, Weiller E, Keskiner A, Schinka J, Knapp E, Sheehan MF, Dunbar G: The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability. Eur Psychiatry. 1997, 12: 232-241.CrossRef Sheehan D, Lecrubier Y, Sheehan K, Janavs J, Weiller E, Keskiner A, Schinka J, Knapp E, Sheehan MF, Dunbar G: The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability. Eur Psychiatry. 1997, 12: 232-241.CrossRef
35.
go back to reference Ladouceur R, Dugas M, Freeston M, Léger E, Gagnon F, Thibodeau N: Efficacy of a cognitive–behavioral treatment for generalized anxiety disorder: Evaluation in a controlled clinical trial. J Consult Clin Psychol. 2000, 68 (6): 957-964.CrossRefPubMed Ladouceur R, Dugas M, Freeston M, Léger E, Gagnon F, Thibodeau N: Efficacy of a cognitive–behavioral treatment for generalized anxiety disorder: Evaluation in a controlled clinical trial. J Consult Clin Psychol. 2000, 68 (6): 957-964.CrossRefPubMed
36.
go back to reference Lorig K, Holman H: Self-management education: History, definition, outcomes, and mechanisms. Ann Behav Med. 2003, 26 (1): 1-7.CrossRefPubMed Lorig K, Holman H: Self-management education: History, definition, outcomes, and mechanisms. Ann Behav Med. 2003, 26 (1): 1-7.CrossRefPubMed
37.
go back to reference Lorig K, González V: The integration of theory with practice: a 12-year case study. Health Educ Q. 1992, 19 (3): 355-368.CrossRefPubMed Lorig K, González V: The integration of theory with practice: a 12-year case study. Health Educ Q. 1992, 19 (3): 355-368.CrossRefPubMed
38.
go back to reference Goldberg D, Gask L, O’Dowd T: The treatment of somatization: teaching techniques of reattribution. J Psychosom Res. 1989, 33 (6): 689-695.CrossRefPubMed Goldberg D, Gask L, O’Dowd T: The treatment of somatization: teaching techniques of reattribution. J Psychosom Res. 1989, 33 (6): 689-695.CrossRefPubMed
39.
go back to reference Tiemens B, Ormel J, Jenner J, van der Meer K, van Os T, van den Brink R, Smit A, van den Brink W: Training primary-care physicians to recognize, diagnose and manage depression: does it improve patient outcomes?. Psychol Med. 1999, 29: 833-845.CrossRefPubMed Tiemens B, Ormel J, Jenner J, van der Meer K, van Os T, van den Brink R, Smit A, van den Brink W: Training primary-care physicians to recognize, diagnose and manage depression: does it improve patient outcomes?. Psychol Med. 1999, 29: 833-845.CrossRefPubMed
40.
go back to reference Beck A, Steer R, Garbin M: Psychometric properties of the Beck Depression inventory: twenty-five years of evaluation. Clin Psychol Rev. 1988, 8: 77-100.CrossRef Beck A, Steer R, Garbin M: Psychometric properties of the Beck Depression inventory: twenty-five years of evaluation. Clin Psychol Rev. 1988, 8: 77-100.CrossRef
41.
go back to reference Beck A, Ward C, Mendelson M, Mock J, Erbauch J: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4: 561-571.CrossRefPubMed Beck A, Ward C, Mendelson M, Mock J, Erbauch J: An inventory for measuring depression. Arch Gen Psychiatry. 1961, 4: 561-571.CrossRefPubMed
42.
go back to reference Jenkinson C, Coulter A, Wright L: Short form 36 (SF 36) health survey questionnaire: normative data for adults of working age. BMJ. 1993, 306: 1437-1438.CrossRefPubMedPubMedCentral Jenkinson C, Coulter A, Wright L: Short form 36 (SF 36) health survey questionnaire: normative data for adults of working age. BMJ. 1993, 306: 1437-1438.CrossRefPubMedPubMedCentral
44.
go back to reference Sherer M: The Self Efficacy Scale; Construction and validation. Psychol Rep. 1982, 51 (2): 663-671.CrossRef Sherer M: The Self Efficacy Scale; Construction and validation. Psychol Rep. 1982, 51 (2): 663-671.CrossRef
45.
go back to reference Bosscher R, Smit J: Confirmatory factor analysis of the General Self-Efficacy Scale. Behav Res Ther. 1998, 36 (3): 339-343.CrossRefPubMed Bosscher R, Smit J: Confirmatory factor analysis of the General Self-Efficacy Scale. Behav Res Ther. 1998, 36 (3): 339-343.CrossRefPubMed
46.
go back to reference Schreurs P: De Utrechtse Coping Lijst: UCL; omgaan met problemen en gebeurtenissen. 1993, Lisse: Swets en Zeitlinger B.V Schreurs P: De Utrechtse Coping Lijst: UCL; omgaan met problemen en gebeurtenissen. 1993, Lisse: Swets en Zeitlinger B.V
47.
go back to reference Arrindell W, Ettema J: SCL-90: handleiding bij een multidimensionele psychopathologie-indicator. 1986, Lisse: Swets en Zeitlinger B.V Arrindell W, Ettema J: SCL-90: handleiding bij een multidimensionele psychopathologie-indicator. 1986, Lisse: Swets en Zeitlinger B.V
48.
go back to reference Koopmanschap M: A modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res. 2005, 5 (1): 23-28.CrossRefPubMed Koopmanschap M: A modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res. 2005, 5 (1): 23-28.CrossRefPubMed
49.
go back to reference Koopmanschap M, Meerding WJ, Evers S, Severens J, Burdorf A, Brouwer W: Handleiding voor het gebruik van PRODISQ versie 2.1 [Manual for the Use of PRODISQ version 2.1]. 2004, Erasmus MC: Instituut voor Medical Technology Assessment, Instituut Maatschappelijke Gezondheidszorg, Universiteit van Maastricht – Beleid Economie en Organisatie van de Zorg Koopmanschap M, Meerding WJ, Evers S, Severens J, Burdorf A, Brouwer W: Handleiding voor het gebruik van PRODISQ versie 2.1 [Manual for the Use of PRODISQ version 2.1]. 2004, Erasmus MC: Instituut voor Medical Technology Assessment, Instituut Maatschappelijke Gezondheidszorg, Universiteit van Maastricht – Beleid Economie en Organisatie van de Zorg
50.
go back to reference Pocock SJ: Clinical trials: A Practical Approach. 1983, Chichester: John Wiley and Sons Pocock SJ: Clinical trials: A Practical Approach. 1983, Chichester: John Wiley and Sons
51.
go back to reference Lamers F, Jonkers CCM, Bosma H, Diederiks JPM, JThM v E: Effectiveness and cost-effectiveness of a minimal psychological intervention to reduce non-severe depression in chronically ill elderly patients: the design of a randomised controlled trial [ISRCTN92331982]. BMC Public Health. 2006, 6: 161-CrossRefPubMedPubMedCentral Lamers F, Jonkers CCM, Bosma H, Diederiks JPM, JThM v E: Effectiveness and cost-effectiveness of a minimal psychological intervention to reduce non-severe depression in chronically ill elderly patients: the design of a randomised controlled trial [ISRCTN92331982]. BMC Public Health. 2006, 6: 161-CrossRefPubMedPubMedCentral
52.
go back to reference Linnan L, Steckler A: Process Evaluation for Public Health Interventions and Research: An Overview. Process Evaluation for Public Health Interventions and Research. Edited by: Steckler A, Linnan L. 2002, San Francisco: Jossey-Bass, I-23. Linnan L, Steckler A: Process Evaluation for Public Health Interventions and Research: An Overview. Process Evaluation for Public Health Interventions and Research. Edited by: Steckler A, Linnan L. 2002, San Francisco: Jossey-Bass, I-23.
Metadata
Title
Effectiveness of a minimal psychological intervention to reduce mild to moderate depression and chronic fatigue in a working population: the design of a randomized controlled trial
Authors
Ed Aelfers
Hans Bosma
Inge Houkes
Jacques ThM van Eijk
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2013
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-13-129

Other articles of this Issue 1/2013

BMC Public Health 1/2013 Go to the issue