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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial

Authors: Sasha-Denise Grünzig, Harald Baumeister, Jürgen Bengel, David Ebert, Lena Krämer

Published in: Trials | Issue 1/2018

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Abstract

Background

Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy.

Methods

In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants’ acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction.

Discussion

This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment.

Trial registration

This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration number DRKS00010282.
Appendix
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Literature
1.
2.
Apolinário-Hagen J, Tasseit S. Chancen und Risiken der Internettherapie für die Regelversorgung in Deutschland. Ein Beitrag zur Psychotherapie im Zeitalter von Web 2.0 [Risks and potential of online therapy for German routine health care. Psychotherapy in the age of web 2.0]. Fachzeitschrift für Onlineberatung und computervermittelte Kommunikation. 2015;11:69–86.
3.
Huckert TF, Hank P, Krampen G. Veränderungen in der Symptombelastung während der Wartezeit auf einen ambulanten Psychotherapieplatz [Changes in psychopathological symptoms during the waiting period for outpatient psychotherapy]. Psychother Psych Med. 2012;62:301–9.CrossRef
4.
Siponen U, Välimäki M. Patients’ satisfaction with outpatient psychiatric care. J Psychiatr Ment Health. 2003;10:129–35.CrossRef
5.
Helbig S, Hoyer J. Hilft wenig viel? Eine Minimalintervention für Patienten während der Wartezeit auf ambulante Verhaltenstherapie [A minimal intervention for patients waiting for outpatient behavioral therapy]. Verhaltenstherapie. 2007;17:109–15.CrossRef
6.
Jacobi F, Wittchen H-U. «Diagnoseträger» und Patienten: Zur Epidemiologie behandelter und unbehandelter psychischer Störungen in Deutschland [The epidemiology of treated and untreated psychiatric diseases in Germany]. Psychotherapeut. 2004;3:17–22.
7.
Hicks C, Hickman G. The impact of waiting-list times on client attendance for relationship counselling. Brit J Guid Couns. 1994;22:175–82.CrossRef
8.
Loumidis KS, Shropshire JM. Effects of waiting time on appointment attendance with clinical psychologists and length of treatment. Ir J Psychol Med. 1997;14:49–54.CrossRef
9.
Hoyer J, Helbig S, Wittchen H-U. Experiences with psychotherapy for depression in routine care: a naturalistic patient survey in Germany. Clin Psychol Psychother. 2006;13:414–21.CrossRef
10.
Musiat P, Goldstone P, Tarrier N. Understanding the acceptability of e-mental health - attitudes and expectations towards computerised self-help treatments for mental health problems. BMC Psychiatry. 2014;14:CD005330.CrossRef
11.
12.
Eells TD, Barrett MS, Wright JH, Thase M. Computer-assisted cognitive-behavior therapy for depression. Psychotherapy. 2014;51:191–7.CrossRefPubMed
13.
Griffiths F, Lindenmeyer A, Powell J, Lowe P, Thorogood M. Why are health care interventions delivered over the internet? A systematic review of the published literature. J Med Internet Res. 2006;8:e10.CrossRefPubMedPubMedCentral
14.
Andersson G, Ljotsson B, Weise C. Internet-delivered treatment to promote health. Curr Opin Psychiatr. 2011;24:168–72.
15.
Baumeister H, Lin J, Ebert D. Internetbasierte Gesundheitsinterventionen [Web-based health care interventions]. In: Koch U, Bengel J, editors. Enzyklopädie der Psychologie: Medizinische Psychologie (Band 2) - Anwendungen der Medizinischen Psychologie. Göttingen: Hogrefe; 2017. p. 231–58.
16.
Lin J, Ebert D, Lehr D, Berking M, Baumeister H. Internetbasierte kognitiv-behaviorale Behandlungsansätze: State of the Art und Einsatzmöglichkeiten in der Rehabilitation [Internet based cognitive behavioral interventions: State of the art and implementation possibilities in rehabilitation]. Rehabilitation. 2013;52:155–63.CrossRefPubMed
17.
Ebert DD, Zarski A-C, Christensen H, et al. Internet and computer-based cognitive behavioral therapy for anxiety and depression in youth: A meta-analysis of randomized controlled outcome trials. PLoS One. 2015;10:e0119895.CrossRefPubMedPubMedCentral
18.
Sander L, Rausch L, Baumeister H. Effectiveness of Internet-based interventions for the prevention of mental disorders: A systematic review and meta-analysis. JMIR Ment Health. 2016;3:e38.CrossRefPubMedPubMedCentral
19.
Baumeister H, Reichler L, Munzinger M, Lin J. The impact of guidance on Internet-based mental health interventions — A systematic review. Internet Interv. 2014;1:205–15.CrossRef
20.
Andersson G, Topooco N, Havik O, Nordgreen T. Internet-supported versus face-to-face cognitive behavior therapy for depression. Expert Rev Neurother. 2016;16:55–60.CrossRefPubMed
21.
Buhrman M, Syk M, Burvall O, Hartig T, Gordh T, Andersson G. Individualized guided Internet-delivered Cognitive-Behavior Therapy for chronic pain patients with comorbid depression and anxiety: A randomized controlled trial. Clin J Pain. 2015;31:504–16.CrossRefPubMed
22.
Königbauer J, Letsch J, Doebler P, Ebert D, Baumeister H. Internet- and mobile-based depression interventions for people with diagnosed depression: A systematic review and meta-analysis. J Affect Disorders. 2017;223:28–40.CrossRef
23.
Kok RN, van Straten A, Beekman ATF, Cuijpers P. Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial. J Med Internet Res. 2014;16:e226.CrossRefPubMedPubMedCentral
24.
Karyotaki E, Riper H, Twisk J, et al. Efficacy of self-guided Internet-based Cognitive Behavioral Therapy in the treatment of depressive symptoms: A meta-analysis of individual participant data. JAMA Psychiat. 2017;74:351–9.CrossRef
25.
Reins JA, Ebert DD, Lehr D, Riper H, Cuijpers P, Berking M. Internet-based treatment of major depression for patients on a waiting list for inpatient psychotherapy: protocol for a multi-centre randomised controlled trial. BMC Psychiatry. 2013;13:318–26.CrossRefPubMedPubMedCentral
26.
Helbig S, Hähnel A, Weigel B, Hoyer J. Wartezeit für Psychotherapiepatienten – und wie sie zu nutzen ist [Waiting times for psychotherapy and how to make the most of it]. Verhaltenstherapie. 2004;14:294–302.CrossRef
27.
Maske UE, Buttery AK, Beesdo-Baum K, Riedel-Heller S, Hapke U, Busch MA. Prevalence and correlates of DSM-IV-TR major depressive disorder, self-reported diagnosed depression and current depressive symptoms among adults in Germany. J Affect Disorders. 2016;190:167–77.CrossRefPubMed
28.
Faller H, Brähler E, Härter M, et al. Performance status and depressive symptoms as predictors of quality of life in cancer patients. A structural equation modeling analysis. Psycho-Oncol. 2015;24:1456–62.CrossRef
29.
Rubio JM, Olfson M, Perez-Fuentes G, Garcia-Toro M, Wang S, Blanco C. Effect of first episode axis I disorders on quality of life. J Nerv Ment Dis. 2014;202:271–4.CrossRefPubMedPubMedCentral
30.
Gallas C, Kächele H, Kraft S, Kordy H, Puschner B. Inanspruchnahme, Verlauf und Ergebnis ambulanter Psychotherapie [Uptake, process and outcomes of outpatient psychotherapy]. Psychotherapeut. 2008;53:414–23.CrossRef
31.
Huprich S, Rosen A, Kiss A. Manifestations of interpersonal dependency and depressive subtypes in outpatient psychotherapy patients. Personal Ment Health. 2013;7:223–32.CrossRefPubMed
32.
Pini S, Perkonnig A, Tansella M, Wittchen H-U. Prevalence and 12-month outcome of threshold and subthreshold mental disorders in primary care. J Affect Disorders. 1999;56:37–48.CrossRefPubMed
33.
Richards D, Richardson T. Computer-based psychological treatments for depression: A systematic review and meta-analysis. Clin Psychol Rev. 2012;32:329–42.CrossRefPubMed
34.
Whitfield G, Hinshelwood R, Pashely A, Campsie L, Williams C. The impact of a novel computerized CBT CD Rom (Overcoming Depression) offered to patients referred to clinical psychology. Behav Cognit Psychother. 2006;34:1–11.CrossRef
35.
Twomey C, O'Reilly G, Byrne M, et al. A randomized controlled trial of the computerized CBT programme, MoodGYM, for public mental health service users waiting for interventions. Br J Clin Psychol. 2014;53:433–50.CrossRefPubMed
36.
Kenter RMF, Cuijpers P, Beekman A, van Straten A. Effectiveness of a web-based guided self-help intervention for outpatients with a depressive disorder: Short-term results from a randomized controlled trial. J Med Internet Res. 2016;18:e80.CrossRefPubMedPubMedCentral
37.
Kenter R, Warmerdam L, Brouwer-Dudokdewit C, Cuijpers P, van Straten A. Guided online treatment in routine mental health care: An observational study on uptake, drop-out and effects. BMC Psychiatry. 2013;13:43.CrossRefPubMedPubMedCentral
38.
Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral
39.
Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMJ Brit Med J. 2010;340:698–702.CrossRef
40.
Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reporting of pragmatic trials: An extension of the CONSORT statement. BMJ Brit Med J. 2008;337:a2390.CrossRefPubMed
41.
Proudfoot J, Klein B, Barak A, Carlbring P. Establishing guidelines for executing and reporting internet intervention research. Cogn Behav Ther. 2011;40:82–97.CrossRefPubMed
42.
Hautzinger M, Bailer M, Hofmeister D, Keller F. Allgemeine Depressionsskala (ADS) [The Center for Epidemiologic Studies Depression Scale (CES-D)]. 2nd ed. Göttingen: Hogrefe; 2012.
43.
Franke GH. Brief Symptom Inventory von L.R. Derogatis (Kurzform der SCL-90-R) - Deutsche Version. Beltz: Göttingen; 2000.
44.
Gellatly J, Bower P, Hennessy S, Richards D, Gilbody S, Lovell K. What makes self-help interventions effective in the management of depressive symptoms? Meta-analysis and meta-regression. Psychol Med. 2007;37:1217–28.CrossRefPubMed
45.
Krämer LV, Helmes AW, Seelig H, Fuchs R, Bengel J. Correlates of reduced exercise behaviour in depression: The role of motivational and volitional deficits. Psychol Health. 2014;29:1206–25.CrossRefPubMed
46.
Buntrock C, Ebert D, Lehr D, et al. Effectiveness of a web-based cognitive behavioural intervention for subthreshold depression: Pragmatic randomised controlled trial. Psychother Psychosom. 2015;84:348–58.CrossRefPubMed
47.
Ebert D, Lehr D, Boß L, et al. Efficacy of an internet-based problem-solving training for teachers: Results of a randomized controlled trial. Scand J Work Environ Health. 2014;40:582–96.CrossRefPubMed
48.
Nobis S, Lehr D, Ebert D, et al. Efficacy of a web-based intervention with mobile phone support in treating depressive symptoms in adults with type 1 and type 2 diabetes: A randomized controlled trial. Diabetes Care. 2015;38:776–83.CrossRefPubMed
49.
Ebert DD, Nobis S, Lehr D, et al. The 6-month effectiveness of Internet-based guided self-help for depression in adults with Type 1 and 2 diabetes mellitus. Diabet Med. 2017;34:99–107.CrossRefPubMed
50.
Ebert DD, Buntrock C, Lehr D, et al. Effectiveness of web- and mobile-based treatment of subthreshold depression with adherence-focused guidance: A single-blind randomized controlled trial. Behav Ther. 2018;49(1):71–83.CrossRefPubMed
51.
Buntrock C, Ebert DD, Lehr D, et al. Effect of a web-based guided self-help intervention for prevention of major depression in adults with subthreshold depression: A randomized clinical trial. JAMA. 2016;315:1854–63.CrossRefPubMed
52.
Lewinsohn PM. A behavioral approach to depression. In: Friedman J, Katz MM, editors. The psychology of depression: Contemporary theory and research. New York: Wiley; 1974. p. 157–85.
53.
D'Zurilla TJ, Nezu AM. Social problem solving in adults. In: Kendall PC, editor. Advances in cognitive-behavioral research and therapy. London: Academic Press; 1986. p. 201–74.
54.
Wyer RS, editor. Perspectives on behavioral self-regulation. Mahwah: Lawrence Erlbaum Associates; 1999.
55.
Titov N. Internet-delivered psychotherapy for depression in adults. Curr Opin Psychiatr. 2011;24:18–23.CrossRef
56.
Kroenke K, Spitzer RL. The PHQ-9: A New Depression Diagnostic and Severity Measure. Psychiat Ann. 2002;32:509–15.CrossRef
57.
Löwe B, Spitzer RL, Gräfe K, et al. Comparative validity of three screening questionnaires for DSM-IV depressive disorders and physicians? J Affect Disorders. 2004;78:131–40.CrossRefPubMed
58.
59.
Fischer EH, Farina A. Attitudes toward seeking professional psychological help: A shortened form and considerations for research. J Coll Student Dev. 1995;36:368–73.
60.
Elhai JD, Schweinle W, Anderson SM. Reliability and validity of the Attitudes Toward Seeking Professional Psychological Help Scale-Short Form. Psychiat Res-Neuroim. 2008;159:320–9.CrossRef
61.
Ladwig I, Rief W, Nestoriuc Y. Welche Risiken und Nebenwirkungen hat Psychotherapie? Entwicklung des Inventars zur Erfassung Negativer Effekte von Psychotherapie (INEP) [What are the risks and side effects to psychotherapy? –Development of an inventory for the assessment of negative effects of psychotherapy (INEP)]. Verhaltenstherapie. 2014;24:252–63.CrossRef
62.
Nobis S, Lehr D, Ebert D, et al. Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2: Design of a randomised controlled trial. BMC Psychiatry. 2013;13:306.CrossRefPubMedPubMedCentral
63.
Thiart H, Lehr D, Ebert DD, Sieland B, Berking M, Riper H. Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain - study protocol for a randomized controlled trial. Trials. 2013;14:169.CrossRefPubMedPubMedCentral
64.
Heber E, Ebert DD, Lehr D, Nobis S, Berking M, Riper H. Efficacy and cost-effectiveness of a web-based and mobile stress-management intervention for employees: design of a randomized controlled trial. BMC Public Health. 2013;13:655.CrossRefPubMedPubMedCentral
65.
Ebert DD, Lehr D, Smit F, et al. Efficacy and cost-effectiveness of minimal guided and unguided internet-based mobile supported stress-management in employees with occupational stress: a three-armed randomised controlled trial. BMC Public Health. 2014;14:807.CrossRefPubMedPubMedCentral
66.
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: Development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6:299–313.CrossRefPubMed
67.
Boss L, Lehr D, Reis D, et al. Reliability and validity of assessing user satisfaction with web-based health interventions. J Med Internet Res. 2016;18:1–13.CrossRef
68.
Deck R, Röckelein E. Zur Erhebung soziodemographischer und sozialmedizinischer Indikatoren in den rehabilitationswissenschaftlichen Forschungsverbünden [Assessing socio-demographic and medical indicators in rehabilitation research]. In: Rentenversicherungsträger VD, editor. Förderschwerpunkt “Rehabilitationswissenschaften” - Empfehlungen der Arbeitsgruppen “Generische Methoden”, “Routinedaten” und “Reha-Ökonomie”. Frankfurt am Main: WDV Wirtschaftsdienst; 1999. p. 84–102.
69.
Papacharissi Z, Rubin AM. Predictors of internet use. J Broadcast Electron. 2000;44:175–96.CrossRef
70.
Seidl H, Bowles D, Bock J-O, et al. FIMA – Fragebogen zur Erhebung von Gesundheitsleistungen im Alter: Entwicklung und Pilotstudie [FIMA – Questionnaire for Health-Related Resource Use in an Elderly Population: Development and pilot study]. Das Gesundheitswesen. 2015;77:46–52.PubMed
71.
Jacobson NS, Truax P. A statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psych. 1991;1:12–9.CrossRef
72.
Junge MN, Lehr D, Bockting C, et al. For whom are internet-based occupational mental health interventions effective? Moderators of internet-based problem-solving training outcome. Internet Interv. 2015;2:39–47.CrossRef
73.
Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: A meta-analysis. PLoS One. 2010;5:1–6.
74.
Swift JK, Callahan JL. The impact of client treatment preferences on outcome: a meta-analysis. J Clin Psychol. 2009;65:368–81.CrossRefPubMed
75.
Bennett-Levy J, Richards DA, Farrand P. Low intensity CBT interventions: a revolution in mental health care. In: Bennett-Levy J, Richards DA, Farrand P, Christensen H, editors. Low intensity CBT interventions. Oxford: Oxford University Press; 2010. p. 3–18.
76.
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;37:319–28.CrossRefPubMed
77.
Buntrock C, Ebert D, Lehr D, et al. Evaluating the efficacy and cost-effectiveness of web-based indicated prevention of major depression: Design of a randomised controlled trial. BMC Psychiatry. 2014;14:25.CrossRefPubMedPubMedCentral
78.
Firth N, Barkham M, Kellett S. The clinical effectiveness of stepped care systems for depression in working age adults: a systematic review. J Affect Disorders. 2015;170:119–30.CrossRefPubMed
79.
Bower P, Gilbody S. Stepped care in psychological therapies: Access, effectiveness and efficiency: Narrative literature review. Br J Psychiatry. 2005;186:11–7.CrossRefPubMed
80.
Baumeister H. Inappropriate prescriptions of antidepressant drugs in patients with subthreshold to mild depression: time for the evidence to become practice. J Affect Disorders. 2012;139:240–3.CrossRefPubMed
81.
Kazdin AE, Blase SL. Rebooting psychotherapy research and practice to reduce the burden of mental illness. Perspect Psychol Sci. 2011;1:21–37.CrossRef
Metadata
Title
Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial
Authors
Sasha-Denise Grünzig
Harald Baumeister
Jürgen Bengel
David Ebert
Lena Krämer
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2657-9

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