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BMC Psychiatry. 2011 Aug 25;11:142. doi: 10.1186/1471-244X-11-142.

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

Author information

  • 1UCLA, School of Public Health, Community Health Sciences Department, Los Angeles, California 90095, USA. loulou.kobeissi@gmail.com

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.

PMID:
21864414
[PubMed - indexed for MEDLINE]
PMCID:
PMC3184263
Free PMC Article
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