Depression in Primary care: Interpersonal Counseling vs Selective serotonin reuptake inhibitors. The DEPICS Study. A multicenter randomized controlled trial. Rationale and design

BMC Psychiatry

Study Protocol

Paola Rucci¹  Annarosa Bombi²  Marco Menchetti²  Domenico Berardi²  Biancamaria Bortolotti²  Paolo Scocco³ 

[1] Department of Medicine and Public Health, Bologna, Italy;Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA;Institute of Psychiatry, Bologna University, Bologna, Italy;Psychiatric Clinic, Department of Neuroscience, Padova University, Padova, Italy;Mental Health Department, ULSS 16 Padova, Padova, Italy;

关键词: Depressive Symptom;    Psychological Intervention;    Borderline Personality Disorder;    Mild Depression;    Zealand Clinical Trial Registry;   

DOI  :  10.1186/1471-244X-10-97

 received in 2010-08-30, accepted in 2010-11-25,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundDepression is a frequently observed and disabling condition in primary care, mainly treated by Primary Care Physicians with antidepressant drugs. Psychological interventions are recommended as first-line treatment by the most authoritative international guidelines but few evidences are available on their efficacy and effectiveness for mild depression.Methods/DesignThis multi-center randomized controlled trial was conducted in 9 Italian centres with the aim to compare the efficacy of Inter-Personal Counseling, a brief structured psychological intervention, to that of Selective Serotonin Reuptake Inhibitors. Patients with depressive symptoms referred by Primary Care Physicians to psychiatric consultation-liaison services were eligible for the study if they met the DSM-IV criteria for major depression, had a score ≥13 on the 21-item Hamilton Depression Rating Scale, and were at their first or second depressive episode. The primary outcome was remission of depressive symptoms at 2-months, defined as a HDRS score ≤ 7. Secondary outcome measures were improvement in global functioning and recurrence of depressive symptoms at 12-months. Patients who did not respond to Inter-Personal Counseling or Selective Serotonin Reuptake Inhibitors at 2-months received augmentation with the other treatment.DiscussionThis trial addresses some of the shortcomings of existing trials targeting major depression in primary care by evaluating the comparative efficacy of a brief psychological intervention that could be easily disseminated, by including a sample of patients with mild/moderate depression and by using different outcome measures.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12608000479303

【 授权许可】

CC BY   
© Menchetti et al; licensee BioMed Central Ltd. 2010