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.
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.
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.
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.
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, I2 = 0%).
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.
This study was supported in part by Grant-in-Aid for Challenging Exploratory Research from Japan Society for the Promotion of Science (JSPS) to T.A.F. and S.T. (No. 26670314) and by Health and Labour Sciences Research Grant to T.A.F. (H25-Seishin-Ippan-002). S.D.H. is supported by NIMH grant MH60713 and MH01697. S.G.H. receives support from NIH/NCCIH (R01AT007257), NIH/NIMH (R01MH099021, R34MH099311, R34MH086668, R21MH102646, R21MH101567, K23MH100259) and the Department of the Army for work unrelated to the studies reported in this article. R.J.D. is supported by NIMH grant MH60998. N.W. has research funds from the Japanese Ministry of Health Labor and Welfare and the Japanese Ministry of Education, Science and Technology. The funders had no role in the study design, the collection, analysis and interpretation of data, the writing of the report, or the decision to submit the article for publication.
- © The Royal College of Psychiatrists 2017.
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