Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
BMC Psychiatry
Published in: BMC Psychiatry 1/2012

Open Access 01-12-2012 | Study protocol

Cost-effectiveness of nurse-led self-help for recurrent depression in the primary care setting: design of a pragmatic randomised controlled trial

Authors: Karolien EM Biesheuvel-Leliefeld, Sandra MA Kersten, Henriette E van der Horst, Anneke van Schaik, Claudi LH Bockting, Judith E Bosmans, Filip Smit, Harm WJ van Marwijk

Published in: BMC Psychiatry | Issue 1/2012

Login to get access

Abstract

Background

Major Depressive Disorder is a leading cause of disability, tends to run a recurrent course and is associated with substantial economic costs due to increased healthcare utilization and productivity losses. Interventions aimed at the prevention of recurrences may reduce patients' suffering and costs. Besides antidepressants, several psychological treatments such as preventive cognitive therapy (PCT) are effective in the prevention of recurrences of depression. Yet, many patients find long-term use of antidepressants unattractive, do not want to engage in therapy sessions and in the primary care setting psychologists are often not available. Therefore, it is important to study whether PCT can be used in a nurse-led self-help format in primary care. This study sets out to test the hypothesis that usual care plus nurse-led self-help for recurrent depression in primary care is feasible, acceptable and cost-effective compared to usual care only.

Design

Patients are randomly assigned to ‘nurse-led self-help treatment plus usual care’ (134 participants) or ‘usual care’ (134 participants). Randomisation is stratified according to the number of previous episodes (2 or 3 previous episodes versus 4 or more). The primary clinical outcome is the cumulative recurrence rate of depression meeting DSM-IV criteria as assessed by the Structured-Clinical-Interview-for-DSM-IV- disorders at one year after completion of the intervention. Secondary clinical outcomes are quality of life, severity of depressive symptoms, co-morbid psychopathology and self-efficacy. As putative effect-moderators, demographic characteristics, number of previous episodes, type of treatment during previous episodes, age of onset, self-efficacy and symptoms of pain and fatigue are assessed. Cumulative recurrence rate ratios are obtained under a Poisson regression model. Number-needed-to-be-treated is calculated as the inverse of the risk-difference. The economic evaluation is conducted from a societal perspective, both as a cost-effectiveness analysis (costs per depression free survival year) and as a cost-utility analysis (costs per quality adjusted life-year).

Discussion

The purpose of this paper is to outline the rationale and design of a nurse-led, cognitive therapy based self-help aimed at preventing recurrence of depression in a primary care setting. Only few studies have focused on psychological self-help interventions aimed at the prevention of recurrences in primary care patients.

Trial registration

NTR3001 (http://​www.​trialregister.​nl)
Appendix
Available only for authorised users
Literature
1.
Murray CJ, Lopez AD: Regional patterns of disability-free life expectancy and disability-adjusted life expectancy: global Burden of Disease Study. Lancet. 1997, 349: 1347-1352. 10.1016/S0140-6736(96)07494-6.CrossRefPubMed
2.
Ormel J, Petukhova M, Chatterji S, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Bromet EJ, Burger H, Demyttenaere K: de GG et al.: Disability and treatment of specific mental and physical disorders across the world. Br J Psychiatry. 2008, 192: 368-375. 10.1192/bjp.bp.107.039107.CrossRefPubMedPubMedCentral
3.
Vos T, Haby MM, Barendregt JJ, Kruijshaar M, Corry J, Andrews G: The burden of major depression avoidable by longer-term treatment strategies. Arch Gen Psychiatry. 2004, 61: 1097-1103. 10.1001/archpsyc.61.11.1097.CrossRefPubMed
4.
Mueller TI, Leon AC, Keller MB, Solomon DA, Endicott J, Coryell W, Warshaw M, Maser JD: Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry. 1999, 156: 1000-1006.PubMed
5.
Paykel ES: Continuation and maintenance therapy in depression. Br Med Bull. 2001, 57: 145-159. 10.1093/bmb/57.1.145.CrossRefPubMed
6.
Van Loenen AC: Farmacotherapeutisch kompas. 2003.
7.
Viguera AC, Baldessarini RJ, Friedberg J: Discontinuing antidepressant treatment in major depression. Harv Rev Psychiatry. 1998, 5: 293-306. 10.3109/10673229809003578.CrossRefPubMed
8.
Piek E, van der Meer K, Nolen WA: Guideline recommendations for long-term treatment of depression with antidepressants in primary care–a critical review. Eur J Gen Pract. 2010, 16: 106-112. 10.3109/13814781003692463.CrossRefPubMed
9.
Kaymaz N: van OJ, Loonen AJ, Nolen WA: Evidence that patients with single versus recurrent depressive episodes are differentially sensitive to treatment discontinuation: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2008, 69: 1423-1436. 10.4088/JCP.v69n0910.CrossRefPubMed
10.
van Schaik DJ, Klijn AF, van Hout HP, van Marwijk HW, Beekman AT: de HM, van DR: Patients' preferences in the treatment of depressive disorder in primary care. Gen Hosp Psychiatry. 2004, 26: 184-189. 10.1016/j.genhosppsych.2003.12.001.CrossRefPubMed
11.
Bockting CL, ten Doesschate MC, Spijker J, Spinhoven P, Koeter MW, Schene AH: Continuation and maintenance use of antidepressants in recurrent depression. Psychother Psychosom. 2008, 77: 17-26. 10.1159/000110056.CrossRefPubMed
12.
Meijer WE, Heerdink ER, Leufkens HG, Herings RM, Egberts AC, Nolen WA: Incidence and determinants of long-term use of antidepressants. Eur J Clin Pharmacol. 2004, 60: 57-61. 10.1007/s00228-004-0726-3.CrossRefPubMed
13.
ten Doesschate MC, Bockting CL, Koeter MW, Schene AH: Predictors of nonadherence to continuation and maintenance antidepressant medication in patients with remitted recurrent depression. J Clin Psychiatry. 2009, 70: 63-69. 10.4088/JCP.08m04119.CrossRefPubMed
14.
Möller HJ, Riedel M, Seemüller F: Relapse or recurrence in depression: why has the cutoff been set at 6 months?. Medicographia. 2011, 33: 125-131.
15.
Frank E, Prien RF, Jarrett RB, Keller MB, Kupfer DJ, Lavori PW, Rush AJ, Weissman MM: Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Arch Gen Psychiatry. 1991, 48: 851-855. 10.1001/archpsyc.1991.01810330075011.CrossRefPubMed
16.
Tohen M, Frank E, Bowden CL, Colom F, Ghaemi SN, Yatham LN, Malhi GS, Calabrese JR, Nolen WA, Vieta E, et al: The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Bipolar Disord. 2009, 11: 453-473. 10.1111/j.1399-5618.2009.00726.x.CrossRefPubMed
17.
Hollon SD, Ponniah K: A review of empirically supported psychological therapies for mood disorders in adults. Depress Anxiety. 2010, 27: 891-932. 10.1002/da.20741.CrossRefPubMedPubMedCentral
18.
Jarrett RB, Kraft D, Doyle J, Foster BM, Eaves GG, Silver PC: Preventing recurrent depression using cognitive therapy with and without a continuation phase: a randomized clinical trial. Arch Gen Psychiatry. 2001, 58: 381-388. 10.1001/archpsyc.58.4.381.CrossRefPubMedPubMedCentral
19.
Vittengl JR, Clark LA, Dunn TW, Jarrett RB: Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007, 75: 475-488.CrossRefPubMedPubMedCentral
20.
Bockting CL, Spinhoven P, Wouters LF, Koeter MW, Schene AH: Long-term effects of preventive cognitive therapy in recurrent depression: a 5.5-year follow-up study. J Clin Psychiatry. 2009, 70: 1621-1628. 10.4088/JCP.08m04784blu.CrossRefPubMed
21.
Bockting CL, Schene AH, Spinhoven P, Koeter MW, Wouters LF, Huyser J, Kamphuis JH: Preventing relapse/recurrence in recurrent depression with cognitive therapy: a randomized controlled trial. J Consult Clin Psychol. 2005, 73: 647-657.CrossRefPubMed
22.
Bijl RV, Ravelli A: Psychiatrische morbididteit, zorggebruik en zorgbehoefte. Resultaten van de Netherlands Mental Health Survey and Incidence Study. Tijdschrift voor Gezondheidswetenschappen. 1998, 76: 446-57.
23.
den Boer PC, Wiersma D, Van den Bosch RJ: Why is self-help neglected in the treatment of emotional disorders? A meta-analysis. Psychol Med. 2004, 34: 959-971. 10.1017/S003329170300179X.CrossRefPubMed
24.
Gregory RJ, Canning SS, Lee TW, Wise JC: Cognitive bibliotherapy for depression: A meta-analysis. Professional Psychology-Research and Practice. 2004, 35: 275-280.CrossRef
25.
McKendree-Smith NL, Floyd M, Scogin FR: Self-administered treatments for depression: a review. J Clin Psychol. 2003, 59: 275-288. 10.1002/jclp.10129.CrossRefPubMed
26.
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
27.
Marrs RW: A meta-analysis of bibliotherapy studies. Am J Community Psychol. 1995, 23: 843-870. 10.1007/BF02507018.CrossRefPubMed
28.
Newman MG, Erickson T, Przeworski A, Dzus E: Self-help and minimal-contact therapies for anxiety disorders: Is human contact necessary for therapeutic efficacy?. J Clin Psychol. 2003, 59: 251-274. 10.1002/jclp.10128.CrossRefPubMed
29.
Spek V, Cuijpers P, Nyklicek 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
30.
Hunkeler EM, Meresman JF, Hargreaves WA, Fireman B, Berman WH, Kirsch AJ, Groebe J, Hurt SW, Braden P, Getzell M, et al: Efficacy of nurse telehealth care and peer support in augmenting treatment of depression in primary care. Arch Fam Med. 2000, 9: 700-708. 10.1001/archfami.9.8.700.CrossRefPubMed
31.
Mynors-Wallis LM, Gath DH, Day A, Baker F: Randomised controlled trial of problem solving treatment, antidepressant medication, and combined treatment for major depression in primary care. BMJ. 2000, 320: 26-30. 10.1136/bmj.320.7226.26.CrossRefPubMedPubMedCentral
32.
First MB, Gibbon M, Spitzer RL, Williams JBW: Structured Clinical Interview for DSM-IV Axis I Disorders. 1996, American Psychiatric Press, Inc, Washington, D.C
33.
Joling KJ, van Marwijk HW, Piek E, van der Horst HE, Penninx BW, Verhaak P, van Hout HP: Do GPs' medical records demonstrate a good recognition of depression? A new perspective on case extraction. J Affect Disord. 2011, 133: 522-527. 10.1016/j.jad.2011.05.001.CrossRefPubMed
34.
Bockting CL, Spinhoven P, Huibers MJ, Edited by Richards S, Perry M: Relapse prevention in recurrent depression using CBT. 2010, American Psychological Association, Washington D.C
35.
Van Marwijk HWJ, Grundmeijer HGLM, Bijl D, Van Gelderen MG, De Haan M, Van Weel-Baumgarten EM, Burgers JS, Boukes FS, Romeijnders ACM: NHG-Standaard Depressieve stoornis (depressie) (Eerste herziening). Huisarts & Wetenschap. 2003, 46: 614-633. 10.1007/BF03083439.CrossRef
36.
Hakkaart-van Roijen L, Van Straten A, Donker M, et al: Manual:Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness (in Dutch). 2002, Rotterdam, Erasmus University
37.
Morisky DE, Green LW, Levine DM: Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986, 24: 67-74. 10.1097/00005650-198601000-00007.CrossRefPubMed
38.
Smelt AF, van der Weele GM, Blom JW, Gussekloo J, Assendelft WJ: How usual is usual care in pragmatic intervention studies in primary care? An overview of recent trials. Br J Gen Pract. 2010, 60: e305-e318.CrossRefPubMedPubMedCentral
39.
Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA: Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000, 68: 615-623.CrossRefPubMed
40.
Ma SH, Teasdale JD: Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004, 72: 31-40.CrossRefPubMed
41.
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, et al: The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003, 54: 573-583. 10.1016/S0006-3223(02)01866-8.CrossRefPubMed
42.
EuroQol group: EuroQol - a new facility for the measurement of health-related quality of life. 1990, The EuroQol Group, Health Policy, 199-208.
43.
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. 10.1097/00005650-199603000-00003.CrossRefPubMed
44.
Terluin B, van Marwijk HW, Ader HJ, de Vet HC, Penninx BW, Hermens ML, van Boeijen CA, van Balkom AJ, van der Klink JJ, Stalman WA: The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry. 2006, 6: 34-10.1186/1471-244X-6-34.CrossRefPubMedPubMedCentral
45.
Schwarzer R, Jerusalem M: Generalized Self-Efficacy scale. 1995, Causal and control beliefs. Edited by Weinman J, Wright S, Johnston M, Windsor, UK, 35-37.
46.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD: The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989, 46: 1121-1123. 10.1001/archneur.1989.00520460115022.CrossRefPubMed
47.
van der Kloot WA, Oostendorp RA: van der MJ, van den HJ: [The Dutch version of the McGill pain questionnaire: a reliable pain questionnaire]. Ned Tijdschr Geneeskd. 1995, 139: 669-673.PubMed
48.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD: Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979, 2: 197-207. 10.1016/0149-7189(79)90094-6.CrossRefPubMed
49.
American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. 1994, American Psychiatric Association, Washington DC
50.
Lamers LM, Stalmeier PF, McDonnell J, Krabbe PF, van Busschbach JJ: Measuring the quality of life in economic evaluations: the Dutch EQ-5D tariff. Ned Tijdschr Geneeskd. 2005, 149: 1574-1578.PubMed
51.
Brazier JE, Roberts J: The estimation of a preference-based measure of health from the SF-12. Med Care. 2004, 42: 851-859. 10.1097/01.mlr.0000135827.18610.0d.CrossRefPubMed
52.
Le LA, Despiegel N, Francois C, Duru G: Can discrete event simulation be of use in modelling major depression?. Cost Eff Resour Alloc. 2006, 4: 19-10.1186/1478-7547-4-19.CrossRef
53.
Penninx BW, Nolen WA, Lamers F, Zitman FG, Smit JH, Spinhoven P, Cuijpers P, de Jong PJ, van Marwijk HW, der Meer KV, et al: Two-year course of depressive and anxiety disorders: Results from the Netherlands Study of Depression and Anxiety (NESDA). J Affect Disord. 2011, 133 (1–2): 76-85.CrossRefPubMed
54.
Paykel ES: Partial remission, residual symptoms, and relapse in depression. Dialogues Clin Neurosci. 2008, 10: 431-437.PubMedPubMedCentral
55.
Van Voorhees BW, Paunesku D, Kuwabara SA, Basu A, Gollan J, Hankin BL, Melkonian S, Reinecke M: Protective and vulnerability factors predicting new-onset depressive episode in a representative of U.S. adolescents. J Adolesc Health. 2008, 42: 605-616. 10.1016/j.jadohealth.2007.11.135.CrossRefPubMed
56.
Geerlings SW, Twisk JW, Beekman AT, Deeg DJ: van TW: Longitudinal relationship between pain and depression in older adults: sex, age and physical disability. Soc Psychiatry Psychiatr Epidemiol. 2002, 37: 23-30. 10.1007/s127-002-8210-2.CrossRefPubMed
57.
Skapinakis P, Lewis G, Mavreas V: Temporal relations between unexplained fatigue and depression: longitudinal data from an international study in primary care. Psychosom Med. 2004, 66: 330-335. 10.1097/01.psy.0000124757.10167.b1.CrossRefPubMed
58.
Segal ZV, Kennedy S, Gemar M, Hood K, Pedersen R, Buis T: Cognitive reactivity to sad mood provocation and the prediction of depressive relapse. Arch Gen Psychiatry. 2006, 63: 749-755. 10.1001/archpsyc.63.7.749.CrossRefPubMed
59.
Hakkaart-van Roijen L, Tan SS, Bouwmans CAM: Handleiding voor kostenonderzoek. 2010, Instituut voor Medical Technology Assessment iov CZV, Rotterdam
60.
Oostenbrink JB, Koopmanschap MA, Rutten C: Standardisation of Costs. 2002, The Dutch Manual for Costing in Economic Evaluations, Adis International
61.
Koopmanschap MA, Rutten FF, van Ineveld BM, van Roijen L: The friction cost method for measuring indirect costs of disease. J Health Econ. 1995, 14: 171-189. 10.1016/0167-6296(94)00044-5.CrossRefPubMed
62.
Boston RC, Sumner AE: STATA: a statistical analysis system for examining biomedical data. Adv Exp Med Biol. 2003, 537: 353-369. 10.1007/978-1-4419-9019-8_23.CrossRefPubMed
63.
Cohen SB: An evaluation of alternative PC-based software packages developed for the analysis of complex survey data. The American Statistician. 1997, 51: 285-292.
64.
Van Buuren S, Oudshoorn CGM: Multivariate imputation by chained equations. 2000, MICE V1.0 user's manual. Leiden, TNO Preventie en Gezondheid
65.
66.
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
67.
Hoch JS, Rockx MA, Krahn AD: Using the net benefit regression framework to construct cost-effectiveness acceptability curves: an example using data from a trial of external loop recorders versus Holter monitoring for ambulatory monitoring of "community acquired" syncope. BMC Health Serv Res. 2006, 6: 68-10.1186/1472-6963-6-68.CrossRefPubMedPubMedCentral
Metadata
Title
Cost-effectiveness of nurse-led self-help for recurrent depression in the primary care setting: design of a pragmatic randomised controlled trial
Authors
Karolien EM Biesheuvel-Leliefeld
Sandra MA Kersten
Henriette E van der Horst
Anneke van Schaik
Claudi LH Bockting
Judith E Bosmans
Filip Smit
Harm WJ van Marwijk
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2012
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-12-59

Other articles of this Issue 1/2012

BMC Psychiatry 1/2012 Go to the issue

Research article

Volunteering in the care of people with severe mental illness: a systematic review

Research article

Development of mental disorders one year after exposure to psychosocial stressors; a cohort study in primary care patients with a physical complaint

Research article

Anxiety symptoms among Chinese nurses and the associated factors: a cross sectional study

Research article

Cannabis use and depression: a longitudinal study of a national cohort of Swedish conscripts

Research article

Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database

Research article

Risk factors for suicide behaviors in the observational schizophrenia outpatient health outcomes (SOHO) study