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Behavioural activation v. antidepressant medication for treating depression in Iran: randomised trial

  • Latif Moradveisi (a1), Marcus J. H. Huibers (a2), Fritz Renner (a3), Modabber Arasteh (a4) and Arnoud Arntz (a5)...
Abstract
Background

Behavioural activation might be a viable alternative to antidepressant medication for major depressive disorder.

Aims

To compare the effectiveness of behavioural activation and treatment as usual (TAU, antidepressant medication) for major depressive disorder in routine clinical practice in Iran.

Method

Patients with major depressive disorder (n = 100) were randomised to 16 sessions of behavioural activation (n = 50) or antidepressant medication (n = 50) (IRCT138807192573N1). The main outcome was depression, measured with the Beck Depression inventory (BDI) and the Hamilton Rating Scale for Depression (HRSD), assessed at 0, 4, 13 and 49 weeks.

Results

Symptom reduction was greater in the behavioural activation group than in the TAU group on both the BDI and the HRSD at 13 and 49 weeks in multilevel analysis. Baseline depression severity was a moderator, with relatively better effects for behavioural activation in individuals who were more severely depressed. Also, there was better retention in the behavioural activation than in the TAU group.

Conclusions

Behavioural activation is a viable and effective treatment for people with major depressive disorder, especially for those who are more severely depressed, and it can successfully be disseminated into routine practice settings in a non-Western country such as Iran.

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Copyright
Corresponding author
Arnoud Arntz, Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands. Email: Arnoud.Arntz@maastrichtuniversity.nl
Footnotes
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Declaration of interest

None.

Footnotes
References
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8 Dobson, KS, Hollon, SD, Dimidjian, S, Schmaling, KB, Kohlenberg, RJ, Gallop, RJ, et al Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the prevention of relapse and recurrence in major depression. J Consult Clin Psychol 2008; 76: 468–77.
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Behavioural activation v. antidepressant medication for treating depression in Iran: randomised trial

  • Latif Moradveisi (a1), Marcus J. H. Huibers (a2), Fritz Renner (a3), Modabber Arasteh (a4) and Arnoud Arntz (a5)...
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eLetters

Results of behavioural activation over-stated!

Dr Mukesh Kripalani, Consultant Psychiatrist
10 April 2013

Dear Sir/Madam

I am re-submitting it as we are unsure you have received the previously submitted version.

Thanks and Regards

Dr Kripalani and Dr Suleman

9-4-13

We looked at the study with great interest, especially as a GP trainee in currently working in Psychiatry. This study, which is applicable to both secondary mental health and primary care, looks at the prospect of using minimally trained staff in using behavioural activation against pharmacological intervention, in the treatment of severe depression.

We would like to highlight the following points for further clarification.

1.An obvious problem of the study is a lack of placebo arm, which would have lent credibility. As you have highlighted the cultural avoidance of antidepressants in the country, adding a placebo group would have removed some bias such as paying for medication in TAU group after 3 months and also in the analysis.

2.Sertraline was used at sub-optimal dose and was slowly titrated against prevailing practise. A meta analysis shows optimum dose for Sertraline range between 100-150mg daily where doses below the therapeuticrange were significantly less effective i.e by 7% (1). Sertraline reachedlowest therapeutic dose of 100mg at 6 weeks. All drop outs in this study took place before mid-point assessment and only 3 were due to medication side effects.

3.There is significant difference in attention that participants received in each group. Participants in behavioural activation group received 50% more face to face session than TAU group. The study did not adjust for this in the analysis.

4.Last observation carried forward (LOCF) was used in the study. However, 5% drop outs occurred in the behavioural activation group as opposed to a significant 30% from TAU group. LOCF is used frequently in Intention to Treat (ITT) studies but standard errors and confidence intervals from LOCF underestimates uncertainty (2). As there are no strategies for universal use, reasons for the choice of a certain method have to be provided when designing and analysing clinical trials (3). LOCFanalysis seems to have favoured the behavioural activation group.

Many other limitations of the study are cited in the paper itself. Significant numbers of participants were recruited via advertisement or word of mouth which seemed to have attracted more women and perhaps more psychological minded patients. It would have been important to include thetypes of advertisement run with this paper in order to identify any bias.

Finally, we wondered if an ethics committee would allow this to go ahead in the United Kingdom since it included severely depressed individuals. Before committing to a study, patients with severe depressionmust be assessed to have capacity to consent to randomisation and treatment (GMC Consent guidance (Para1). We would like clarification if that was performed.

References

1Bollini P, Pampallona S, Tibaldi G, Kupelnick B, Munizza C.Effectiveness of antidepressants. Meta-analysis of dose-effect relationships in randomised clinical trials. Br J Psychiatry 1999; 174: 297-303.

2Mallinckrodt, C., Clark, W., & David, S. Accounting for dropoutbias using mixed-effects models .Journal Of Biopharmaceutical Statistics 2001; 11(1-2): 9-21.

3Unnebrink K, Windeler J. Intention-to-treat: methods for dealing with missing values in clinical trials of progressively deteriorating diseases. Stat Med 2001; 20(24) :3931-46.

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Conflict of interest: None declared

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