The Relaxation Exercise and Social Support Trial (RESST): a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms

Persistent Link:
http://hdl.handle.net/10150/610093
Title:
The Relaxation Exercise and Social Support Trial (RESST): a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptoms
Author:
Kobeissi, Loulou; Mahfoud, Ziyad; Khoury, Brigitte; El Kak, Fayssal; Ghantous, Zeina; Khawaja, Marwan; Nakkash, Rima; Ramia, Sami; Zurayk, Huda; Araya, Ricardo; Peters, Tim
Affiliation:
Epidemiology and Biostatistics Division, Center for Middle Eastern Studies, University of Arizona, Tucson, Arizona, USA; Center for Research on Population and Health Epidemiology and Population Health Department Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon; Department of Public Health, Weill Cornell Medical College, Doha, Qatar; Department of Psychiatry-Faculty of Medicine, American University of Beirut, Beirut, Lebanon; Department of Health Promotion and Community Health Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon; Center for Research on Population and Health Epidemiology and Population Health Department Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon; Center for Research on Population and Health Department of Health Promotion and Community Health Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon; Medical Lab Sciences Program Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon; Academic Unit of Psychiatry School of Social and Community Medicine, University of Bristol, Bristol, UK; School of Clinical Sciences, University of Bristol, Bristol, UK
Issue Date:
2012
Publisher:
BioMed Central
Citation:
Kobeissi et al. BMC Psychiatry 2012, 12:195 http://www.biomedcentral.com/1471-244X/12/195
Journal:
BMC Psychiatry
Rights:
© 2012 Kobeissi et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)
Collection Information:
This item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.
Abstract:
BACKGROUND:Symptoms such as medically unexplained vaginal discharge (MUVD) are common and bothersome, leading to potentially unnecessary use of resources.METHODS:A community-based individually randomized controlled trial to assess the effectiveness of a relatively simple, culturally appropriate multi-component intervention on reducing reported MUVD, among women suffering from low-moderate levels of common mental distress. The setting was a socio-economically deprived, informal settlement in the southern suburbs of Beirut, Lebanon. The intervention comprised up to 12 group sessions implemented over a six-week period, each divided into a psychosocial and a relaxation exercise component. The primary outcome was self-reported MUVD, which was defined as a complaint of vaginal discharge 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. Blinding on the intervention status was not possible for both logistic and ethical reasons, especially as knowledge of involvement in the intervention was integral to its delivery. Intent to treat analysis was used.RESULTS:Of 75 women randomized to the intervention, 48% reported MUVD at 6 months compared with 63% of 73 in the control group (difference of -15%, 95% confidence interval (CI) -31%, 0%, p=0.067). Adjustments for baseline imbalances and any factors relating to consent had no appreciable effect on these results. The risk of MUVD was reduced in absolute terms by 2.4% for each intervention session attended (95% CI -4.9%, 0.0%, p=0.049). While there was also marginal evidence of a beneficial effect on anxiety, there was no evidence of mediation of the effect on MUVD through measures of common mental disorders.CONCLUSION:This study confirms that MUVD is an important public health problem. While the benefits of this intervention may appear modest, the intervention offers an opportunity for women to enhance their problem-solving skills as well as use physical relaxation techniques that can help them deal with stressful in their lives. Further research is needed in a variety of contexts, for different populations and preferably involving larger randomized trials of such an intervention.TRIAL REGISTRATION:* Title of trial: The Relaxation Exercise and Social Support TrialISRCTN assigned: ISRCTN98441241Date of assignation: 10/09/2010Link: http://www.controlled-trials.com/ISRCTN98441241 webcite* Also registered at the Wellcome Trust register:http://www.controlled-trials.com/mrct/trial/469943/98441241 webcite
EISSN:
1471-244X
DOI:
10.1186/1471-244X-12-195
Version:
Final published version
Additional Links:
http://www.biomedcentral.com/1471-244X/12/195

Full metadata record

DC FieldValue Language
dc.contributor.authorKobeissi, Loulouen
dc.contributor.authorMahfoud, Ziyaden
dc.contributor.authorKhoury, Brigitteen
dc.contributor.authorEl Kak, Fayssalen
dc.contributor.authorGhantous, Zeinaen
dc.contributor.authorKhawaja, Marwanen
dc.contributor.authorNakkash, Rimaen
dc.contributor.authorRamia, Samien
dc.contributor.authorZurayk, Hudaen
dc.contributor.authorAraya, Ricardoen
dc.contributor.authorPeters, Timen
dc.date.accessioned2016-05-20T08:58:23Z-
dc.date.available2016-05-20T08:58:23Z-
dc.date.issued2012en
dc.identifier.citationKobeissi et al. BMC Psychiatry 2012, 12:195 http://www.biomedcentral.com/1471-244X/12/195en
dc.identifier.doi10.1186/1471-244X-12-195en
dc.identifier.urihttp://hdl.handle.net/10150/610093-
dc.description.abstractBACKGROUND:Symptoms such as medically unexplained vaginal discharge (MUVD) are common and bothersome, leading to potentially unnecessary use of resources.METHODS:A community-based individually randomized controlled trial to assess the effectiveness of a relatively simple, culturally appropriate multi-component intervention on reducing reported MUVD, among women suffering from low-moderate levels of common mental distress. The setting was a socio-economically deprived, informal settlement in the southern suburbs of Beirut, Lebanon. The intervention comprised up to 12 group sessions implemented over a six-week period, each divided into a psychosocial and a relaxation exercise component. The primary outcome was self-reported MUVD, which was defined as a complaint of vaginal discharge 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. Blinding on the intervention status was not possible for both logistic and ethical reasons, especially as knowledge of involvement in the intervention was integral to its delivery. Intent to treat analysis was used.RESULTS:Of 75 women randomized to the intervention, 48% reported MUVD at 6 months compared with 63% of 73 in the control group (difference of -15%, 95% confidence interval (CI) -31%, 0%, p=0.067). Adjustments for baseline imbalances and any factors relating to consent had no appreciable effect on these results. The risk of MUVD was reduced in absolute terms by 2.4% for each intervention session attended (95% CI -4.9%, 0.0%, p=0.049). While there was also marginal evidence of a beneficial effect on anxiety, there was no evidence of mediation of the effect on MUVD through measures of common mental disorders.CONCLUSION:This study confirms that MUVD is an important public health problem. While the benefits of this intervention may appear modest, the intervention offers an opportunity for women to enhance their problem-solving skills as well as use physical relaxation techniques that can help them deal with stressful in their lives. Further research is needed in a variety of contexts, for different populations and preferably involving larger randomized trials of such an intervention.TRIAL REGISTRATION:* Title of trial: The Relaxation Exercise and Social Support TrialISRCTN assigned: ISRCTN98441241Date of assignation: 10/09/2010Link: http://www.controlled-trials.com/ISRCTN98441241 webcite* Also registered at the Wellcome Trust register:http://www.controlled-trials.com/mrct/trial/469943/98441241 webciteen
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttp://www.biomedcentral.com/1471-244X/12/195en
dc.rights© 2012 Kobeissi et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)en
dc.titleThe Relaxation Exercise and Social Support Trial (RESST): a community-based randomized controlled trial to alleviate medically unexplained vaginal discharge symptomsen
dc.typeArticleen
dc.identifier.eissn1471-244Xen
dc.contributor.departmentEpidemiology and Biostatistics Division, Center for Middle Eastern Studies, University of Arizona, Tucson, Arizona, USAen
dc.contributor.departmentCenter for Research on Population and Health Epidemiology and Population Health Department Faculty of Health Sciences, American University of Beirut, Beirut, Lebanonen
dc.contributor.departmentDepartment of Public Health, Weill Cornell Medical College, Doha, Qataren
dc.contributor.departmentDepartment of Psychiatry-Faculty of Medicine, American University of Beirut, Beirut, Lebanonen
dc.contributor.departmentDepartment of Health Promotion and Community Health Faculty of Health Sciences, American University of Beirut, Beirut, Lebanonen
dc.contributor.departmentCenter for Research on Population and Health Epidemiology and Population Health Department Faculty of Health Sciences, American University of Beirut, Beirut, Lebanonen
dc.contributor.departmentCenter for Research on Population and Health Department of Health Promotion and Community Health Faculty of Health Sciences, American University of Beirut, Beirut, Lebanonen
dc.contributor.departmentMedical Lab Sciences Program Faculty of Health Sciences, American University of Beirut, Beirut, Lebanonen
dc.contributor.departmentAcademic Unit of Psychiatry School of Social and Community Medicine, University of Bristol, Bristol, UKen
dc.contributor.departmentSchool of Clinical Sciences, University of Bristol, Bristol, UKen
dc.identifier.journalBMC Psychiatryen
dc.description.collectioninformationThis item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
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