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Logo of bmcpsycBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Psychiatry
 
BMC Psychiatry. 2011; 11: 142.
Published online 2011 August 25. doi:  10.1186/1471-244X-11-142
PMCID: PMC3184263
The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial
Loulou Kobeissi,corresponding author1,2 Ricardo Araya,3 Fayssal El Kak,4 Zeina Ghantous,2 Marwan Khawaja,2 Brigitte Khoury,5 Ziyad Mahfoud,6 Rima Nakkash,7 Tim J Peters,8 Sami Ramia ,9 and Huda Zurayk2
1UCLA, School of Public Health, Community Health Sciences Department, 650 E Charles Young Dr, Los Angeles, California 90095, USA
2Center for Research on Population and Health, Epidemiology and Population Health Department, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
3Academic Unit of Psychiatry, School of Social and Community Medicine, University of Bristol, Bristol, UK
4Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
5Department of Psychiatry, Faculty of Medicine, American University of Beirut, Beirut, Lebanon
6Department of Public Health, Weill Cornell Medical College, Doha, Qatar
7Center for Research on Population and Health, Department of Health Promotion and Community Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
8School of Clinical Sciences, University of Bristol, Bristol, UK
9Medical Lab Sciences Program, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon
corresponding authorCorresponding author.
Loulou Kobeissi: loulou.kobeissi/at/gmail.com; Ricardo Araya: r.araya/at/bristol.ac.uk; Fayssal El Kak: fk01/at/aub.edu.lb; Zeina Ghantous: zeinaghantous/at/yahoo.com; Marwan Khawaja: marwan.khawaja/at/gmail.com; Brigitte Khoury: bk03/at/aub.edu.lb; Ziyad Mahfoud: zm15/at/aub.edu.lb; Rima Nakkash: rn06/at/aub.edu.lb; Tim J Peters: tim.peters/at/bristol.ac.uk; Sami Ramia : sramia/at/aub.edu.lb; Huda Zurayk: hzurayk/at/aub.edu.lb
Received June 21, 2011; Accepted August 25, 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
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