Background
Major Depression (MD) is an important public health problem, associated with high levels of disability, impairment in quality of life, and increased mortality rates [
1,
2], similarly to severe medical conditions like congestive heart failure and diabetes [
3]. Moreover, depression is associated with high health services utilization, work absenteeism, and decreased performances at work [
4,
5] with elevated direct and indirect social costs. Epidemiological studies showed that MD has a high prevalence in primary care ranging from 2.6% to 29.5% [
6‐
8].
Many patients with depression seek help in primary care and an increasing proportion has been treated in this setting, especially since the availability of safe and easy to use antidepressants (ADs) [
9]. However, some problems remain in the management of depression in primary care, including the insufficient duration of antidepressant treatment and the limited use of non-pharmacological options [
10‐
12]. In particular, psychological interventions are rarely used even for those patients who could benefit from them: patients suffering from mild depression related to stressful life events and patients in which the risk/benefits ratio of antidepressants is less favourable (e.g. elderly, frail patients, patients with polypharmacotherapy, women with post-partum depression). Several reasons account for this limited use: the small number of trained therapists in primary care [
13,
14], the physician's positive opinion and attitude on drug treatment [
15,
16], the few evidence on the comparative efficacy and effectiveness of brief psychotherapies vs antidepressants.
However, psychological interventions are often preferred by primary care patients [
17,
18] and are recommended as first-line treatment by the most authoritative international guidelines [
19,
20].The APA guidelines [
19] stated that antidepressants or an effective psychotherapy alone may be considered as the first-line treatment for patients with mild to moderate major depression. The National Institute for Clinical Evidence (NICE) guidelines [
20] recommend not to use antidepressants routinely to treat mild depression because the risk-benefit ratio is poor and suggest as an alternative a range of low-intensity psychosocial interventions.
These recommendations are based on few trials directly comparing antidepressant drugs with different kinds of psychological interventions in primary care [
21‐
28]. Therefore the NICE guidelines underscore that adequately powered Randomized Controlled Trial (RCT) are warranted with representative participant samples, reporting relevant outcomes to assess the efficacy of psychological interventions and antidepressants [
20].
The objectives of the RCT described in this paper are: 1) to evaluate the efficacy of a psychological intervention, the Inter-Personal Counseling (IPC), compared with Selective Serotonin Reuptake Inhibitors (SSRIs), for mild to moderate MD; 2) and to assess the efficacy of treatment augmentation with SSRI or IPC in patients who do not respond to monotherapy.
Discussion
Many studies have been conducted on the treatment of depression, but mostly on patients with moderate to severe forms in the mental health setting. Relatively few trials have been carried out with patients with mild depression in primary care. In particular, evidence on the efficacy of psychological interventions in comparison with antidepressants is scanty. To our knowledge only eight RCTs comparing different psychological interventions and antidepressants were conducted in primary care [
21‐
28]. However, methodological issues limit the findings of these trials: first,, they had very small sample sizes, thereby increasing the likelihood of Type II error; moreover the three older ones used tricyclic antidepressants that are now rarely prescribed [
21‐
23]; finally, two studies recruited only patients suffering from minor depression or dysthimia [
27,
28]. As suggested by several authors, it is crucial that RCTs on psychological interventions conducted in primary care include representative participant samples, use multiple outcome measures, test interventions easy to disseminate and evaluate differences in treatment response as a function of co-existent psychiatric problems and other medical problems [
13,
62‐
64]. Considering the challenges researchers must overcome, the DEPICS study has some points of strengths:
1)
The use of broad eligibility criteria in order to obtain a representative sample, including patients with mild depression and depressive disorders comorbid with anxiety disorders or physical illnesses, very common in primary care setting.
2)
The use of different outcome measures and a broad assessment including severity of depressive symptom, functioning, quality of life, interpersonal relationships, and patient's satisfaction,
3)
The evaluation of the efficacy of a brief structured psychological intervention (IPC) as a monotherapy for MD in primary care.
Among evidence-based psychotherapies for depression, the interpersonal approach is one of the most supported, but qualified psychotherapists are often not available in primary care. If we want to see widespread implementation of effective practices such as evidence -based psychotherapies, we need to develop and test "simpler" versions of evidence based psychosocial treatment that could be provided by different health-care professionals who do not necessarily have mental health training [
64]. With a view of moving from research evidence to practice, IPC lends itself to be disseminated in primary care, because it is a briefer version of evidence-based psychosocial treatments and could be provided by clinicians with less mental health expertise than IPT or CBT therapists. The efficacy of IPC has been previously tested in patients with depressive symptoms related to current stress (mainly physical illnesses) and subthreshold depression or in individual, group and telephone format [
32,
37‐
41,
65]. One study evaluated the efficacy of IPC plus venlafaxine for MD in primary care [
36]. Moreover, Bolton et al [
65] tested the efficacy of group IPC in alleviating depressive symptoms and dysfunction in patients with sub-threshold or major depression in Uganda. However, IPC was not previously tested as an individual intervention in monotherapy for patients with MD in primary care.
An important limitation of this study is the absence of a placebo group, usually characterized by a high rate of spontaneous remission (27% to 43%) [
22,
66,
67]. However, the present study is part of a more comprehensive collaborative programme between primary care and mental health services and we chose to employ only an active comparator in the protocol to match the real-world clinical setting as closely as possible. Another limitation is the exclusion of patients with more than one clinically significant depressive episode in their personal history. We chose to exclude these patients because of the different pattern of response to treatment and the less favourable prognosis [
9]. Our results therefore cannot be generalized to patients with chronic or recurrent MD.
In conclusion, the present trial aims to provide evidence on the efficacy of a brief and easy to implement psychological intervention compared to the most frequently used drug treatments for major depression.
Acknowledgements
We want to acknowledge the ideas and the support of professor D. Goldberg, Institute of Psychiatry, King's College London.
Moreover we are grateful to F. Asioli for his suggestions in the protocol development and to R. N. Forgione for his assistance in database development and management.
We wish to thank for their help, the members of Italian Society of General Practice, P. Carbonatto and T. Scarponi.
We thank all the members of the DEPICS Study Group:
V. Affatatia, G. Alberinib, F. Baranzinib, S. Bellinoc, A Bellomod, T. Blasie, F Bogettoc, P. Bortolasob, C. Callegarib, B. Carpiniellof, N. Colombinig, C. Contuf, G. Crocib, M. De Salviad, M. Diurnib, S. Eliseie, M. Ferrettid, P. Fiored, P. Fusar-Polii, S. Iusod, A. Lacalamitaa, T. La Ferlae, L. Liai, C.C. Lucianoi, M. Magnanii, D. Manganaroi, V. Martinellih, I. Martinoa, M. B. Montagutii, C. Nespecai, A. Petitod, F. Pinnaf, M. Pisellie, P. Politih, R. Quartesane, A. Rellae, F. Restainoh, M. Rigatellig, P. Sciarinih, E. Simonig, M. Succui, E. Tedeschinig, O. Todarelloa, S. Venderb, L. Zaccagnie, M. Zizzac
a Department of Psychiatry, University of Bari, Bari, Italy.
b Department of Medicine, University of Insubria, Varese, Italy
c Unit of Psychiatry, Department of Neurosciences, University of Turin, Turin, Italy
d Section of Psychiatry and Clinical Psychology, Department of Medical Sciences, University of Foggia, Foggia, Italy
e Department of Clinical and Experimental Medicine, (Division of Psychiatry, Clinical Psychology and Psychiatric Rehabilitation), University of Perugia, Perugia, Italy
f Department of Mental Health, Section of Psychiatry, University of Cagliari, Cagliari, Italy.
g Mental Health Department, USL Modena, Italy
h Department of Health Applied Sciences, Section of Psychiatry, University of Pavia, Pavia, Italy
i Institute of Psychiatry, Bologna University, Bologna, Italy
We also thank G. Lullini, and E. Pedrini (Institute of Psychiatry, Bologna University), A. D'Onghia, M. Mazza, and S. Papagni (Section of Psychiatry and Clinical Psychology, Department of Medical Sciences, University of Foggia) for their collaboration to the study.
Funding
The study was funded by the Italian Ministry for Education, University and Research (Prot. 2005063749).
Competing interests
The authors declare that they have no competing interests.
Authors' contributions
DB, MM, BB conceived the study and developed the study protocol. DB is the principal investigator that assembled the group of investigators. MM and BB wrote the first draft of this manuscript, describing the trial protocol. PR provided statistical advice in the design of the study and its on-going evolution. PS, MM and BB participated in the design and in the planning of the interventions. PR, BB and AB managed the trial data. All authors have read and corrected draft versions, and approved the final version.