Hostname: page-component-cd9895bd7-gbm5v Total loading time: 0 Render date: 2025-01-05T16:35:00.341Z Has data issue: false hasContentIssue false
  • English
  • Français

Initial severity of depression and efficacy of cognitive–behavioural therapy: Individual-participant data meta-analysis of pill-placebo-controlled trials

Published online by Cambridge University Press:  02 January 2018

Toshi A. Furukawa ,
Erica S. Weitz ,
Shiro Tanaka ,
Steven D. Hollon ,
Stefan G. Hofmann ,
Gerhard Andersson ,
Jos Twisk ,
Robert J. DeRubeis ,
Sona Dimidjian  and
Ulrich Hegerl
...Show all authors
Toshi A. Furukawa
Affiliation:
Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan
Erica S. Weitz
Affiliation:
Department of Clinical Psychology and EMGO Institute for Health and Care Research, VU University Amsterdam, The Netherlands
Shiro Tanaka
Affiliation:
Department of Pharmacoepidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan
Steven D. Hollon
Affiliation:
Department of Psychology, Vanderbilt University, Nashville, Tennessee, USA
Stefan G. Hofmann
Affiliation:
Department of Psychological and Brain Science, Boston University, Massachusetts, USA
Gerhard Andersson
Affiliation:
Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden and Department of Clinical Neuroscience, Psychiatry Section, Karolinska Institutet, Stokholm, Sweden
Jos Twisk
Affiliation:
Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Amsterdam, The Netherlands
Robert J. DeRubeis
Affiliation:
Department of Psychology, University of Pennsylvania, Philadelphia, Pennsylvania, USA
Sona Dimidjian
Affiliation:
Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, USA
Ulrich Hegerl
Affiliation:
Department of Psychiatry and Psychotherapy, University of Leipzig, Leipzig, Germany
Roland Mergl
Affiliation:
Department of Psychiatry and Psychotherapy, University of Leipzig, Leipzig, Germany
Robin B. Jarrett
Affiliation:
Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, Texas, USA
Jeffrey R. Vittengl
Affiliation:
Department of Psychology, Truman State University, Kirksville, Missouri, USA
Norio Watanabe
Affiliation:
Departments of Health Promotion and Human Behavior and of Clinical Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan
Pim Cuijpers
Affiliation:
Department of Clinical Psychology and EMGO Institute for Health and Care Research, VU University Amsterdam, The Netherlands
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Background

The influence of baseline severity has been examined for antidepressant medications but has not been studied properly for cognitive–behavioural therapy (CBT) in comparison with pill placebo.

Aims

To synthesise evidence regarding the influence of initial severity on efficacy of CBT from all randomised controlled trials (RCTs) in which CBT, in face-to-face individual or group format, was compared with pill-placebo control in adults with major depression.

Method

A systematic review and an individual-participant data meta-analysis using mixed models that included trial effects as random effects. We used multiple imputation to handle missing data.

Results

We identified five RCTs, and we were given access to individual-level data (n = 509) for all five. The analyses revealed that the difference in changes in Hamilton Rating Scale for Depression between CBT and pill placebo was not influenced by baseline severity (interaction P = 0.43). Removing the non-significant interaction term from the model, the difference between CBT and pill placebo was a standardised mean difference of –0.22 (95% CI –0.42 to –0.02, P = 0.03, I 2 = 0%).

Conclusions

Patients suffering from major depression can expect as much benefit from CBT across the wide range of baseline severity. This finding can help inform individualised treatment decisions by patients and their clinicians.

Type
Review Articles
Information
The British Journal of Psychiatry , Volume 210 , Issue 3 , March 2017 , pp. 190 - 196
Copyright
Copyright © Royal College of Psychiatrists, 2017 

Footnotes

*

These authors contributed equally to the work.

Declaration of interest

T.A.F. has received lecture fees from Eli Lilly, Meiji, Mochida, MSD, Otsuka, Pfizer and Tanabe-Mitsubishi and consultancy fees from Sekisui Chemicals and Takeda Science Foundation. He has received royalties from Igaku-Shoin, Seiwa-Shoten and Nihon Bunka Kagaku-sha publishers. He has received grant or research support from the Japanese Ministry of Education, Science and Technology, the Japanese Ministry of Health, Labour and Welfare, the Japan Society for the Promotion of Science, the Japan Foundation for Neuroscience and Mental Health, Mochida and Tanabe-Mitsubishi. He is diplomate of the Academy of Cognitive Therapy. U.H. has received lecture fees from Bristol-Myers Squibb, Medice Arzneimittel, Novartis and Roche Pharma and was an advisory board member for Lilly, Lundbeck, Takeda Pharmaceuticals, Servier and Otsuka Pharma. R.M. has served as a consultant for Nycomed, a Takeda company. R.B.J. received support from the NIMH for the trial cited here (R0MH45043) and is a paid consultant to NIH including the NIMH and to UpToDate. J.R.V. is a paid consultant to UpToDate. N.W. has received royalties from Sogensha and Paquet, and speaker fees and research funds from Asahi Kasei, Dai-Nippon Sumitomo, Eli Lilly, GlaxoSmithKline, Janssen, Meiji, MSD, Otsuka and Pfizer.

References

1 National Institute for Health and Care Excellence. Depression: The Treatment and Management of Depression in Adults (partial update of NICE clinical guideline 23). NICE, 2009.Google Scholar
2 American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (third edition). Am J Psychiatry 2010; 167 (suppl): 1–152.Google Scholar
3 Cuijpers, P, Turner, EH, Mohr, DC, Hofmann, SG, Andersson, G, Berking, M, et al. Comparison of psychotherapies for adult depression to pill placebo control groups: a meta-analysis. Psychol Med 2013: 1–11.Google Scholar
4 Driessen, E, Cuijpers, P, Hollon, SD, Dekker, JJ. Does pretreatment severity moderate the efficacy of psychological treatment of adult outpatient depression? A meta-analysis. J Consult Clin Psychol 2010; 78: 668–80.Google Scholar
5 Simmonds, MC, Higgins, JP. Covariate heterogeneity in meta-analysis: criteria for deciding between meta-regression and individual patient data. Stat Med 2007; 26: 2982–99.Google Scholar
6 Bower, P, Kontopantelis, E, Sutton, A, Kendrick, T, Richards, DA, Gilbody, S, et al. Influence of initial severity of depression on effectiveness of low intensity interventions: meta-analysis of individual patient data. BMJ 2013; 346: f540.Google Scholar
7 Chen, P, Furukawa, TA, Shinohara, K, Honyashiki, M, Imai, H, Ichikawa, K, et al. Quantity and quality of psychotherapy trials for depression in the past five decades. J Affect Disord 2014; 165: 190–5.Google Scholar
8 Barth, J, Munder, T, Gerger, H, Nuesch, E, Trelle, S, Znoj, H, et al. Comparative efficacy of seven psychotherapeutic interventions for patients with depression: a network meta-analysis. PLoS Med 2013; 10: e1001454.Google Scholar
9 Cuijpers, P, Smit, F, Bohlmeijer, E, Hollon, SD, Andersson, G. Efficacy of cognitive–behavioural therapy and other psychological treatments for adult depression: meta-analytic study of publication bias. Br J Psychiatry 2010; 196: 173–8.Google Scholar
10 Furukawa, TA, Noma, H, Caldwell, DM, Honyashiki, M, Shinohara, K, Imai, H, et al. Waiting list may be a nocebo condition in psychotherapy trials: a contribution from network meta-analysis. Acta Psychiatr Scand 2014; 130: 181–92.Google Scholar
11 Cuijpers, P, van Straten, A, Andersson, G, van Oppen, P. Psychotherapy for depression in adults: a meta-analysis of comparative outcome studies. J Consult Clin Psychol 2008; 76: 909–22.Google Scholar
12 Hamilton, M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56–62.Google Scholar
13 DeRubeis, RJ, Hollon, SD, Amsterdam, JD, Shelton, RC, Young, PR, Salomon, RM, et al. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry 2005; 62: 409–16.Google Scholar
14 Dimidjian, S, Hollon, SD, Dobson, KS, Schmaling, KB, Kohlenberg, RJ, Addis, ME, et al. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol 2006; 74: 658–70.Google Scholar
15 Beck, AT, Ward, CH, Mendelson, M, Mock, J, Erbaugh, J. An inventory for measuring depression. Arch Gen Psych 1961; 4: 561–71.Google Scholar
16 Little, RJ, D'Agostino, R, Cohen, ML, Dickersin, K, Emerson, SS, Farrar, JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012; 367: 1355–60.Google Scholar
17 National Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. National Academies Press, 2010.Google Scholar
18 Stewart, LA, Clarke, M, Rovers, M, Riley, RD, Simmonds, M, Stewart, G, et al. Preferred reporting items for systematic review and meta-analyses of individual participant data: the PRISMA-IPD Statement. JAMA 2015; 313: 1657–65.Google Scholar
19 Elkin, I, Shea, MT, Watkins, JT, Imber, SD, Sotsky, SM, Collins, JF, et al. National Institute of Mental Health Treatment of Depression Collaborative Research Program. General effectiveness of treatments. Arch Gen Psychiatry 1989; 46: 971–82.Google Scholar
20 Jarrett, RB, Schaffer, M, McIntire, D, Witt-Browder, A, Kraft, D, Risser, RC. Treatment of atypical depression with cognitive therapy or phenelzine: a double-blind, placebo-controlled trial. Arch Gen Psychiatry 1999; 56: 431–7.Google Scholar
21 Hegerl, U, Hautzinger, M, Mergl, R, Kohnen, R, Schutze, M, Scheunemann, W, et al. Effects of pharmacotherapy and psychotherapy in depressed primary-care patients: a randomized, controlled trial including a patients' choice arm. Int J Neuropsychopharmacol 2010; 13: 31–44.Google Scholar
22 Cuijpers, P, Turner, EH, Mohr, DC, Hofmann, SG, Andersson, G, Berking, M, et al. Comparison of psychotherapies for adult depression to pill placebo control groups: a meta-analysis. Psychol Med 2014; 44: 685–95.Google Scholar
23 Cunningham, JA, Kypri, K, McCambridge, J. Exploratory randomized controlled trial evaluating the impact of a waiting list control design. BMC Med Res Methodol 2013; 13: 150.Google Scholar
24 Fawcett, J, Epstein, P, Fiester, SJ, Elkin, I, Autry, JH. Clinical management–imipramine/placebo administration manual. NIMH Treatment of Depression Collaborative Research Program. Psychopharmacol Bull 1987; 23: 309–24.Google Scholar
25 Butler, AC, Chapman, JE, Forman, EM, Beck, AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev 2006; 26: 17–31.Google Scholar
26 Cuijpers, P, van Straten, A, Bohlmeijer, E, Hollon, SD, Andersson, G. The effects of psychotherapy for adult depression are overestimated: a meta-analysis of study quality and effect size. Psychol Med 2010; 40: 211–23.Google Scholar
27 Lynch, D, Laws, KR, McKenna, PJ. Cognitive behavioural therapy for major psychiatric disorder: does it really work? A meta-analytical review of well-controlled trials. Psychol Med 2010; 40: 9–24.Google Scholar
28 Stewart, LA, Tierney, JF. To IPD or not to IPD? Advantages and disadvantages of systematic reviews using individual patient data. Eval Health Prof 2002; 25: 76–97.Google Scholar
29 Riley, RD, Lambert, PC, Abo-Zaid, G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ 2010; 340: c221.Google Scholar
30 Turner, EH, Matthews, AM, Linardatos, E, Tell, RA, Rosenthal, R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358: 252–60.Google Scholar
31 Amick, HR, Gartlehner, G, Gaynes, BN, Forneris, C, Asher, GN, Morgan, LC, et al. Comparative benefits and harms of second generation antidepressants and cognitive behavioral therapies in initial treatment of major depressive disorder: systematic review and meta-analysis. BMJ 2015; 351: h6019.Google Scholar
32 Weitz, ES, Hollon, SD, Twisk, J, van Straten, A, Huibers, MJ, David, D, et al. Baseline depression severity as moderator of depression outcomes between cognitive behavioral therapy vs pharmacotherapy: an individual patient data meta-analysis. JAMA Psychiatry 2015; 72: 1102–9.Google Scholar
33 Fournier, JC, DeRubeis, RJ, Hollon, SD, Dimidjian, S, Amsterdam, JD, Shelton, RC, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 2010; 303: 47–53.Google Scholar
34 Furukawa, TA, Levine, SZ, Tanaka, S, Goldberg, Y, Samara, M, Davis, JM, et al. Initial severity of schizophrenia and efficacy of antipsychotics: participant-level meta-analysis of 6 placebo-controlled studies. JAMA Psychiatry 2015; 72: 14–21.Google Scholar
35 Gibbons, RD, Hur, K, Brown, CH, Davis, JM, Mann, JJ. Benefits from antidepressants: synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine. Arch Gen Psychiatry 2012; 69: 572–9.Google Scholar
36 Gartlehner, G, Hansen, RA, Morgan, LC, Thaler, K, Lux, L, Van Noord, M, et al. Comparative benfits and harms of second-generation antidepressants for treating major depressive disorder: an updated meta-analysis. Ann Intern Med 2011; 155: 772–85.Google Scholar
37 Ioannidis, JP, Karassa, FB. The need to consider the wider agenda in systematic reviews and meta-analyses: breadth, timing, and depth of the evidence. BMJ 2010; 341: c4875.Google Scholar
38 Institute of Medicine Committee on Strategies for Responsible Sharing of Clinical Trial Data. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks. National Academic Press, 2015.Google Scholar
39 Furukawa, TA. From effect size into number needed to treat. Lancet 1999; 353: 1680.Google Scholar
Supplementary material: PDF

Furukawa et al. supplementary material

Supplementary Figure S1

Download Furukawa et al. supplementary material(PDF)
PDF 31.4 KB
Submit a response

eLetters

No eLetters have been published for this article.