Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

INTRODUCTION: Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19. METHODS AND ANALYSIS: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes. ETHICS AND DISSEMINATION: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies. TRIAL REGISTRATION: The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.

Exploration of associations between deliberate self-poisoning and psychiatric disorders in rural Sri Lanka: A case-control study.

Psychiatric disorders are important predictors of deliberate self-harm. The present study was carried out to determine the associations between DSM-IV TR Axis- I & II disorders and deliberate self-poisoning (DSP) in a rural agricultural district in Sri Lanka. Patients residing in the district who presented with DSP were randomly selected for the study. Both the cases and age, sex, and, residential area, matched controls were assessed for DSM-IV TR Axis- I & II disorders based on the Structured Clinical Interview for DSM-IV-TR Axis I and II Disorders (SCID I & II) conducted by a specialist psychiatrist. Cases consisted of 208 (47.4%) males and 231 (52.6%) females. More than one third (37%) of males and more than half (53.7%) of females were aged below 20 years. DSM-IV TR axis-I and/or II psychiatric diagnoses were diagnosed in 89 (20.3%) of cases and 14 (3.2%) controls. Cases with a DSM-IV TR axis-I diagnosis were older than the cases without psychiatric diagnosis (32 and 19 years), p<0.0001. Having a depressive episode was associated with a 19 times higher risk for DSP. Being a male aged > = 30 years and having an alcohol use disorder carried a 21 times excess risk for DSP. A fivefold excess risk for DSP was found among 10-19 year old females with borderline personality traits. Depressive disorder and alcohol-related disorders were significantly associated with the older participants who presented with DSP. The overall prevalence of psychiatric disorders associated with DSP in rural Sri Lanka was significantly lower compared to the rates reported in the West and other countries in the region. Therefore, health and research priorities to reduce self-harm in Sri Lanka should focus both on psychiatric and non-psychiatric factors associated with DSP.

A prospective study of repetition of self-harm following deliberate self-poisoning in rural Sri Lanka.

INTRODUCTION: Repetition of deliberate self-harm is an important predictor of subsequent suicide. Repetition rates in Asian countries appear to be significantly lower than in western high-income countries. Methodological differences in studies, and the impact of access to means of self-harm with comparatively higher lethality have been suggested as reasons for these reported differences. This prospective study determines the rates and demographic patterns of deliberate self-poisoning (DSP), suicide and repeated deliberate self-harm resulting non-fatal and fatal outcomes in rural Sri Lanka. METHODS: Details of DSP admission in all hospitals (n = 46) and suicides reported to all police stations (n = 28) in a rural district were collected for the years 2011, 2012 and 2013. Demographic details of the cohort of patients admitted to all hospitals in 2011 due to deliberate self-poisoning (N = 4022), were screened to link with patient records and police reports of the successive two years with high sensitivity using a computer program. Then high specificity manual matching of all screened links was performed to identify repetition within 2 years of initial presentation. Life time repetition was assessed in a randomly selected subset of DSP patients (n = 433). RESULTS: There were 15,639 DSP admissions, aged more than 9 years, and 1078 suicides during the study period. The incidence of deliberate self-poisoning and suicide in the population within the study area were 248.3/100,000 and 20.7/100,000 respectively, in 2012. Repetition rates at four weeks, one-year and two-years were 1.9% (95% CI 1.5-2.3%), 5.7% (95% CI 5.0-6.4) and 7.9% (95% CI 7.1-8.8) respectively. The median interval between two attempts were 92 (IQR 10-238) and 191 (IQR 29-419.5) days for the one and two-year repetition groups. The majority of patients used the same poison in the repeat attempt. The age and duration of hospital stay of individuals with repetitive events were not significantly different from those who had no repetitive events. The rate of suicide at two years following DSP was 0.7% (95% CI 0.4-0.9%). The reported life time history of deliberate self-harm attempts was 9.5% (95% CI 6.7-12.2%). CONCLUSIONS: The comparatively low rates of repetition in rural Sri Lanka was not explained by higher rates of suicide, access to more lethal means or differences in study methodology.

Prevalence of major depressive disorder among spouses of men who use alcohol in a rural community in Central Sri Lanka.

AIMS: To estimate the prevalence of major depressive disorder (MDD) among spouses of men who use alcohol in two rural areas in Sri Lanka, and to examine whether the severity of alcohol-related problems (ARPs) in men and presence of alcohol-related domestic violence are associated with MDD among these women. METHOD: In a cross-sectional study, ARPs among men were assessed using Alcohol Use Disorders Identification Test (AUDIT) questionnaire filled in by men, and domestic violence and husbands' drinking pattern data obtained from the women. MDD among the women was ascertained using the Structured Clinical Interview for DSM-IV Disorders for major depression. Using logistic regression we examined whether age, past history of depression, different indices of ARPs and domestic violence were associated with current MDD among the women. RESULTS: Point prevalence of MDD in the sample was 33.3% (95% CI: 25.93, 40.73%). Once adjusted for other factors, morning drinking of the spouse (odds ratio = 4.11, 95% CI: 1.25, 13.47; P = 0.019) and increasing age (odds ratio = 1.05, 95% CI: 1.01, 1.09; P = 0.003) significantly increased the odds of MDD. Being subjected to domestic violence/arguments also had a trend to be associated with MDD among women, but was not significant (odds ratio = 2.29, 95% CI: 0.95, 5.48; P = 0.062). CONCLUSION: The prevalence of MDD among spouses of men who use alcohol is markedly higher than that has been observed among Sri Lankan women in previous studies. The prevalence of MDD in women seems to increase when their husbands are morning drinkers, and with increasing age.

The Clinical Interview Schedule--Sinhala version: validation in a community setting in Sri Lanka.

The Clinical Interview Schedule Revised (CIS-R) was validated in a clinic setting for adolescents 15-19 years of age in Sri Lanka. The interview schedule was translated into Sinhala and modified to include sections introducing each symptom group. One-hundred-and-thirty-one adolescents attending a psychiatric clinic for the first time were interviewed by a lay interviewer using CIS-R (Translated). They had previously been examined and rated by a psychiatrist using local (emic) diagnostic procedures. All the filtering questions showed a high level of sensitivity (80%-96%). None of the questions in the sleep problems and phobias sections were effective at discriminating between those who did and did not show significant symptoms in these areas according to the psychiatrist. The internal consistency of the sections of the interview schedule (when these two sections were excluded) varied between 0.60 and 0.82. Linear regression showed that, when both sections were excluded, 97% of the variation of total score could be explained. Therefore, it was decided to exclude the sleep problems and phobias sections from the modified interview schedule. As the population samples are likely to be different from clinic samples it is necessary to test the validity again in a community sample before confirming the validity of the modified interview schedule.