[show abstract][hide abstract] 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* Also registered at the Wellcome Trust register:http://www.controlled-trials.com/mrct/trial/469943/98441241.
[show abstract][hide abstract] ABSTRACT: To evaluate and compare the prevalence and risk factors for anxiety and depression in adults with beta-thalassemia major (TM) and intermedia (TI).
A cross-sectional study of TI and TM patients at a Chronic Care Center in Lebanon. A total of 80 patients agreed to participate (32 TI (median age 24 years) and 48 TM (median age 23 years)). The Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI) questionnaires were used to assess the depression and anxiety levels of patients, respectively. Data on patient demographics, clinical complications, and socioeconomic status were also collected.
Patients with TM had a significantly longer median duration with a known thalassemia diagnosis than patients with TI (p < 0.001). A considerable proportion of patients had depression (35.0%), State (S)-anxiety (22.5%) or Trait (T)-anxiety (36.2%). Patients with TI had a higher median S-anxiety score compared with TM (p = 0.035), although the median T-anxiety and depression scores were similar. On linear regression analysis, the significant association between the thalassemia diagnosis (TM versus TI) and S-anxiety score (beta: 5.740; 95% CI: 0.201 to 11.278; p = 0.042) was no longer observed upon adjustment for the co-variate duration with a known thalassemia diagnosis (beta: 3.162; 95% CI: -2.949 to 9.274; p = 0.306).
A considerable proportion of adult patients with TM and TI show evidence of depression and anxiety. Patients with TI are more liable to state anxiety than TM patients of a similar age, which is attributed to a shorter duration of living with a thalassemia diagnosis.
The International Journal of Psychiatry in Medicine 01/2012; 44(4):291-303. · 1.15 Impact Factor
[show abstract][hide abstract] ABSTRACT: This paper presents the process evaluation of a community-based randomized psycho-social trial aimed to enhance reproductive and mental health outcomes of disadvantaged women living in the southern suburb of Beirut-Lebanon. Process evaluation of public health interventions involves the monitoring and documentation of interventions' implementation to allow for better understanding of planned outcomes and of intervention effectiveness.
A community-based randomized trial was conducted. The intervention consisted of 12 sessions (of combined 30 minutes of relaxation exercises and 75 minutes of structured support groups) delivered twice per week over a period of six-weeks. A process evaluation was conducted during the implementation of the intervention. This process evaluation aimed to ensure that the intervention was delivered and implemented as planned, as well as to monitor women's satisfaction and attendance. The main components of the process evaluation included: dose delivered, dose received, and reach. Closed ended questionnaires were administered before/after/during each intervention session. Data was entered and analyzed using SPSS. Analysis revolved around simple frequency distribution for categorical variables and means (SD) for continuous variables. Limited bivariate analysis (using CHI Square and Anova) was done.
RESULTS indicated that the delivery, implementation, and reach of the intervention were favorable. Participation was acceptable and satisfaction rates were very high.
These favorable findings pertaining to intervention satisfaction, reach and participation highlight a number of lessons for future intervention studies in the context of disadvantaged settings. They also support the importance of involving the local community members in intervention planning, implementation and evaluation early on. We believe that the community involvement in this trial directly and significantly contributed to the results of this process evaluation.
Global journal of health science 01/2012; 4(1):22-32.
[show abstract][hide abstract] ABSTRACT: 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.
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.
The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress).
The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241.
[show abstract][hide abstract] ABSTRACT: In patients with β thalassaemia intermedia (TI), the milder anaemia and transfusion independence imply better health-related quality of life (HR-QoL). However, the unbalanced pathophysiology of the disease allows for several serious clinical complications to manifest, which may have a negative impact on HR-QoL.
This was a cross-sectional study on adult patients with transfusion- and iron chelation-independent TI and β thalassaemia major (TM) attending the Chronic Care Center, Hazmieh, Lebanon. A total of 80 patients agreed to participate in the study [32 TI (median age 24 yr) and 48 TM (median age 23 yr)]. The RAND SF-36 survey was used to assess HR-QoL. Data on patient demographics, clinical complications and socioeconomic status were collected.
Patients with TI and TM were comparable with age and gender, but patients with TM had a significantly longer median duration with a known thalassaemia diagnosis. Patients with TI had a higher proportion of multiple complications. Socioeconomic parameters were comparable, except for patients with TI being more commonly married. The mean Total, Physical Health and Mental Health Scores were significantly lower in patients with TI compared to TM, indicating poorer HR-QoL. There was a statistically significant positive correlation between the duration with a known thalassaemia diagnosis and a higher Mental Health Score (r(s) = 0.73, P = 0.020). The mean Physical Health Score was significantly lower in patients with multiple clinical complications compared to patients with single or no complications (P = 0.012). Associations remained independently significant at multivariate analysis.
Patients with transfusion-independent TI have lower HR-QoL compared to TM patients. At a comparable age, the shorter duration since diagnosis and the multiplicity of complications may explain these findings.
European Journal Of Haematology 07/2011; 87(1):73-9. · 2.55 Impact Factor