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Open Access Study protocol

The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

Loulou Kobeissi12*, Ricardo Araya3, Fayssal El Kak4, Zeina Ghantous2, Marwan Khawaja2, Brigitte Khoury5, Ziyad Mahfoud6, Rima Nakkash7, Tim J Peters8, Sami Ramia9 and Huda Zurayk2

Author Affiliations

1 UCLA, School of Public Health, Community Health Sciences Department, 650 E Charles Young Dr, Los Angeles, California 90095, USA

2 Center for Research on Population and Health, Epidemiology and Population Health Department, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon

3 Academic Unit of Psychiatry, School of Social and Community Medicine, University of Bristol, Bristol, UK

4 Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon

5 Department of Psychiatry, Faculty of Medicine, American University of Beirut, Beirut, Lebanon

6 Department of Public Health, Weill Cornell Medical College, Doha, Qatar

7 Center for Research on Population and Health, Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon

8 School of Clinical Sciences, University of Bristol, Bristol, UK

9 Medical Lab Sciences Program, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon

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BMC Psychiatry 2011, 11:142  doi:10.1186/1471-244X-11-142

Published: 25 August 2011

Abstract

Background

Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health.

Methods/Design

This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD) in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks). Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs), through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25). Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used.

Discussion

The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress).

Trial Registration

The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241