East Asian Arch Psychiatry 2015;25:137-8
Letters to the Editor
To the Editor: I read with interest the study by Kumar and Gupta,1 published in March 2015 issue, on the effectiveness of psycho-educational intervention in patients with depression and their caregivers that found significant differences in outcome measures. Psycho-educational interventions as add-on to pharmacotherapy were reported to significantly reduce depressive symptoms as well as improve global functioning and psychological wellbeing. I have some reservations about these findings based on the facts in the study. First, as mentioned by the authors, the study was carried out over a period of 3 months, from April to June 2012. All patients were assessed at baseline, 4, 8, and 12 weeks on the rating instruments. This would only have been possible if all 80 patients mentioned were recruited on the same day, as the last follow-up was after 3 months. This appears highly improbable. Second, the authors mentioned that “a total of 80 eligible subjects were recruited and randomised alternately into 2 groups”; such type of alternate allocation is not a true randomisation procedure.2 In the subsequent paragraph they mentioned that another group of newly diagnosed subjects served as controls. This again raises concern about the process of randomisation. Third, it appears that all patients were receiving medications (details not mentioned) as per the discretion of the treating clinician, but the exclusion criteria for patients included “partially treated or current treatment for depression”. This seems counterintuitive. Fourth, the psycho-educational intervention included only 4 sessions (duration of each session was not specified) given at baseline, 2, 4, and 8 weeks to 1 group of patients and caregivers. The authors found a significant reduction in depression scale score from 4 weeks onwards in the intervention group, i.e. when the patients had had only 2 sessions of psycho-education. At 12 weeks the difference in the Hamilton Depression Rating Scale scores between the groups was significant at p < 0.001, with a strong effect size (Cohen’s d = 1.3).3 Furthermore, there were no corrections made for multiple testing at various time points. A more appropriate statistical test in this situation would be repeated measures analysis of variance4 that could have controlled for the baseline differences in the scores too.
Samir Kumar Praharaj,
MBBS, MD, DPM (email: samirpsyche@yahoo.co.in)
Department of Psychiatry, Kasturba Medical College, Manipal, Karnataka, India 576104
References
- Kumar K, Gupta M. Effectiveness of psycho-educational intervention in improving outcome of unipolar depression: results from a randomised clinical trial. East Asian Arch Psychiatry 2015;25:29-34.
- Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:e1-37.
- Rosenthal R. Meta-analytic procedures for social research. Newbury Park, CA: Sage; 1991.
- Park E, Cho M, Ki CS. Correct use of repeated measures analysis of variance. Korean J Lab Med 2009;29:1-9.
Authors’ Reply
To the Editor: The authors welcome the critical analysis of our paper.1 It has brought to our notice several errors of omission in our manuscript.
In response to this letter, we make several submissions as follows. The study was conducted over a period of 1 year between April 2012 and May 2013 after obtaining the required ethical clearance. This was a typographical error in the manuscript and our sincere regrets to your readers.
Next, it has been pointed out that the method of randomisation carried out in our study, i.e. alternation, is not a true procedure. The authors agree that alternation is no longer considered a credible randomisation procedure but as a basic approach in a naturalistic clinical setting its role cannot be dismissed. The first proponent of randomised clinical trials, Bradford Hill, advocated the use of alternation over other randomisation methods as elucidated in an article.2 As a method of sample allocation, alternation is one of the best methods due to its simplicity and providing matched samples at baseline. It may have its disadvantages but so do other methods of randomisation such as simple randomisation or stratified randomisation.
The randomisation was done only for the 2 study groups and not for the control group that served as a comparator group. The exclusion criteria in question were meant only for the purpose of recruitment of subjects into the study. Those subjects who had been partially treated or were currently on treatment for depression were not included in the study. Nonetheless following inclusion, the pharmacological treatment was not controlled for and this was mentioned in the limitations section of our paper.
The results did show significant reduction in the Hamilton Depression Rating Scale scores in the intervention group at 4 weeks and this was the highlight of our study. It may or may not be replicated by other studies but it argues strongly for including psycho-education as an add-on therapy for almost all patients with depression and their caregivers. We agree to the recommendation that analysis of variance is a better tool for analysis of variance in repeated
Letters to the Editor measures such as in our study.
We again thank Dr Praharaj for his critical comments and for helping us improve our research standards.
Kuldip Kumar
Department of Psychiatry, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi 110029, India
Manushree Gupta (email: manushree@outlook.com)
Safdarjung Hospital & Vardhaman Mahavir Medical College, New Delhi 110029, India (currently in Department of Psychiatry, GB Pant Hospital & Maulana Azad Medical College, New Delhi 110029, India)
References
- Kumar K, Gupta M. Effectiveness of psycho-educational intervention in improving outcome of unipolar depression: results from a randomised clinical trial. East Asian Arch Psychiatry 2015;25:29-34.
- Chalmers I, Clarke M. J Guy Scadding and the move from alternation to randomization. JLL Bulletin: Commentaries on the history of treatment evaluation; 2002.
