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Open Access 01-12-2011 | Study protocol

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

Authors: Loulou Kobeissi, Ricardo Araya, Fayssal El Kak, Zeina Ghantous, Marwan Khawaja, Brigitte Khoury, Ziyad Mahfoud, Rima Nakkash, Tim J Peters, Sami Ramia, Huda Zurayk

Published in: BMC Psychiatry | Issue 1/2011

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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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-244X/11/142/prepub

Title: The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial
Authors: Loulou Kobeissi
Ricardo Araya
Fayssal El Kak
Zeina Ghantous
Marwan Khawaja
Brigitte Khoury
Ziyad Mahfoud
Rima Nakkash
Tim J Peters
Sami Ramia
Huda Zurayk
Publication date: 01-12-2011
Publisher: BioMed Central
Published in: BMC Psychiatry / Issue 1/2011
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/1471-244X-11-142

At a glance: The STEP trials

Springer Medicine

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

Abstract

Background

Methods/Design

Discussion

Trial Registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/Design

Discussion

Trial Registration

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