Lay health worker led intervention for depressive and anxiety disorders in India: impact on clinical and disability outcomes over 12 months.

BACKGROUND: Depressive and anxiety disorders (common mental disorders) are the most common psychiatric condition encountered in primary healthcare. AIMS: To test the effectiveness of an intervention led by lay health counsellors in primary care settings (the MANAS intervention) to improve the outcomes of people with common mental disorders. METHOD: Twenty-four primary care facilities (12 public, 12 private) in Goa (India) were randomised to provide either collaborative stepped care or enhanced usual care to adults who screened positive for common mental disorders. Participants were assessed at 2, 6 and 12 months for presence of ICD-10 common mental disorders, the severity of symptoms of depression and anxiety, suicidal behaviour and disability levels. All analyses were intention to treat and carried out separately for private and public facilities and adjusted for the design. The trial has been registered with clinical trials.gov (NCT00446407). RESULTS: A total of 2796 participants were recruited. In public facilities, the intervention was consistently associated with strong beneficial effects over the 12 months on all outcomes. There was a 30% decrease in the prevalence of common mental disorders among those with baseline ICD-10 diagnoses (risk ratio (RR) = 0.70, 95% CI 0.53-0.92); and a similar effect among the subgroup of participants with depression (RR = 0.76, 95% CI 0.59-0.98). Suicide attempts/plans showed a 36% reduction over 12 months (RR=0.64, 95% CI0.42­0.98) among baseline ICD-10 cases. Strong effects were observed on days out of work and psychological morbidity, and modest effects on overall disability [corrected]. In contrast, there was little evidence of impact of the intervention on any outcome among participants attending private facilities. CONCLUSIONS: Trained lay counsellors working within a collaborative-care model can reduce prevalence of common mental disorders, suicidal behaviour, psychological morbidity and disability days among those attending public primary care facilities.

The integration of the treatment for common mental disorders in primary care: experiences of health care providers in the MANAS trial in Goa, India.

BACKGROUND: The MANAS trial reported that a Lay Health Counsellor (LHC) led collaborative stepped care intervention (the "MANAS intervention") for Common Mental Disorders (CMD) was effective in public sector primary care clinics but private sector General Practitioners (GPs) did as well with or without the additional counsellor. This paper aims to describe the experiences of integrating the MANAS intervention in primary care. METHODS: Qualitative semi-structured interviews with key members (n = 119) of the primary health care teams upon completion of the trial and additional interviews with control arm GPs upon completion of the outcome analyses which revealed non-inferiority of this arm. RESULTS: Several components of the MANAS intervention were reported to have been critically important for facilitating integration, notably: screening and the categorization of the severity of CMD; provision of psychosocial treatments and adherence management; and the support of the visiting psychiatrist. Non-adherence was common, often because symptoms had been controlled or because of doubt that health care interventions could address one's 'life difficulties'. Interpersonal therapy was intended to be provided face to face by the LHC; however it could not be delivered for most eligible patients due to the cost implications related to travel to the clinic and the time lost from work. The LHCs had particular difficulty in working with patients with extreme social difficulties or alcohol related problems, and elderly patients, as the intervention seemed unable to address their specific needs. The control arm GPs adopted practices similar to the principles of the MANAS intervention; GPs routinely diagnosed CMD and provided psychoeducation, advice on life style changes and problem solving, prescribed antidepressants, and referred to specialists as appropriate. CONCLUSION: The key factors which enhance the acceptability and integration of a LHC in primary care are training, systematic steps to build trust, the passage of time, the observable impacts on patient outcomes, and supervision by a visiting psychiatrist. Several practices by the control arm GPs approximated those of the LHC which may partly explain our findings that they were as effective as the MANAS intervention arm GPs in enabling recovery.

Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial.

BACKGROUND: Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. METHODS: In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. FINDINGS: 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00-1·47; risk difference=12·1%, 95% CI 1·6%-22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02-2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74-1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. INTERPRETATION: A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. FUNDING: The Wellcome Trust.

Integrating evidence-based treatments for common mental disorders in routine primary care: feasibility and acceptability of the MANAS intervention in Goa, India.

Common mental disorders, such as depression and anxiety, pose a major public health burden in developing countries. Although these disorders are thought to be best managed in primary care settings, there is a dearth of evidence about how this can be achieved in low resource settings. The MANAS project is an attempt to integrate an evidence based package of treatments into routine public and private primary care settings in Goa, India. Before initiating the trial, we carried out extensive preparatory work, over a period of 15 months, to examine the feasibility and acceptability of the planned intervention. This paper describes the systematic development and evaluation of the intervention through this preparatory phase. The preparatory stage, which was implemented in three phases, utilized quantitative and qualitative methods to inform our understanding of the potential problems and possible solutions in implementing the trial and led to critical modifications of the original intervention plan. Investing in systematic formative work prior to conducting expensive trials of the effectiveness of complex interventions is a useful exercise which potentially improves the likelihood of a positive result of such trials.

Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India.

BACKGROUND AND OBJECTIVE: Common mental disorders (CMD) are a leading global burden of disease. Up to 30% of primary care attenders suffer from these disorders but most do not receive evidence-based drug or psychological treatments. There are no trials of interventions which attempt to integrate these treatments into routine primary care in developing countries. The aims of this trial (the MANAS Project) are to evaluate the clinical and cost-effectiveness of a collaborative stepped-care intervention for the treatment of CMD in India. STUDY DESIGN: A cluster randomized controlled trial will be implemented in the state of Goa, on the west coast of India. Twenty-four primary care facilities, 12 from the government sector and 12 from the private sector, will be enrolled in two consecutive phases. For each sector, facilities will be randomly allocated within strata defined by urban/rural location, population size and presence of a visiting psychiatrist. Facilities will be randomly allocated to receive the collaborative stepped care intervention or the enhanced usual care control intervention. Both arms share two components of the intervention, viz., routine screening, and in the government clinics provision of antidepressants. In addition, the collaborative stepped care arm also provides a range of psychosocial treatments delivered by a specially trained Health Counselor, and supervision by a visiting Psychiatrist. A total of 3600 primary care attenders who are detected to suffer from a CMD based on a validated screening questionnaire will be recruited. The primary outcome is the proportion of subjects who recover from an ICD10 defined CMD at baseline by 6 months. Additional endpoints at 2 and 12 months will assess the speed and sustainability of achieving the primary outcomes. Other outcomes will include recovery from ICD10 defined depression and incidence of ICD-10 among individuals who were sub-threshold cases at baseline. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios. IMPLICATIONS: This will be the first trial of the effectiveness of a complex intervention aiming to integrate efficacious treatments for CMD into routine primary care in a developing country. If effective, its findings will have relevance to policy makers who wish to scale up treatments for CMD in primary care across the world, but mostly in those countries where specialist mental health services are few. STUDY REGISTRATION: The MANAS project is registered through the National Institutes of Health sponsored clinical trials registry and has been assigned the identifier: NCT00446407.

The explanatory models of depression in low income countries: listening to women in India.

INTRODUCTION: Women, and persons facing social and economic disadvantage, are at greater risk for depressive disorders. Our objective was to describe the explanatory models of illness in depressed women, in particular, their idioms of distress, and their views of their social circumstances and how this related to their illness. METHOD: We carried out a qualitative investigation nested in a population based cohort study of women's mental and reproductive health in Goa, India. We purposively sampled women who were ever-married and who had been found to be suffering from a depressive disorder on the basis of a structured diagnostic interview. In-depth interviews were carried out about six months apart exploring stressors in women's lives, a typical day in their recent lives, and their illness narratives (idioms of distress, causal models, impact of illness, help-seeking). RESULTS: 35 women consented to participate in the study, 28 completing both interviews. Women gave expression to their problems primarily through somatic complaints, typically a variety of body aches, autonomic symptoms, gynecological symptoms and sleep problems. There was frequent mention of overall "weakness" and tiredness. Economic difficulties and difficulties with interpersonal relationships (particularly related to marital relationships) were the most common causal models. However, women rarely considered biomedical concepts, for example, the notion that they may suffer from an illness or that their complaints were due to a biochemical disturbance in the brain. Despite the lack of a biomedical concept, most of the participants had sought medical help, typically for reproductive and somatic complaints. CONCLUSIONS: We recommend the use of somatic idioms as the defining clinical features, and a broader, psychosocial model for understanding the aetiology and conceptualization of the clinical syndrome of depression for public health interventions and mental health promotion in the Indian context.

Risk factors for common mental disorders in women. Population-based longitudinal study.

BACKGROUND: The determinants of common mental disorders in women have not been described in longitudinal studies from a low-income country. METHOD: Population-based cohort study of 2494 women aged 18 to 50 years, in India. The Revised Clinical Interview Schedule was used for the detection of common mental disorders. RESULTS: There were 39 incident cases of common mental disorder in 2166 participants eligible for analysis (12-month rate 1.8%, 95% CI 1.3-2.4%). The following baseline factors were independently associated with the risk for common mental disorder: poverty (low income and having difficulty making ends meet); being married as compared with being single; use of tobacco; experiencing abnormal vaginal discharge; reporting a chronic physical illness; and having higher psychological symptom scores at baseline. CONCLUSIONS: Programmes to reduce the burden of common mental disorder in women should target poorer women, women with chronic physical illness and who have gynaecological symptoms, and women who use tobacco.

Common genital complaints in women: the contribution of psychosocial and infectious factors in a population-based cohort study in Goa, India.

BACKGROUND: The genital complaint of abnormal vaginal discharge is common in South Asia. We describe the risk factors for the incidence of the complaint in women of reproductive age. Method Population-based cohort study in Goa, India. Out of 3000 randomly selected women, 2494 women participated. The outcome was an incident case of the complaint of abnormal vaginal discharge at 6 months (T1) and 12 months (T2) review. RESULTS: In total 71 (3.6%, 95% CI 2.8-4.5%) of the 2000 eligible women reviewed at T1 reported the complaint; and 80 (4.0%, CI 3.2-5.0%) of the 1999 women who did not complain of abnormal vaginal discharge at T1 reported it at T2. Multivariate logistic regression analysis identified the following factors as associated with the complaint: younger age (OR 0.26, CI 0.1-0.5 for women aged 40-49 years compared with women aged 18-24 years); illiteracy (OR 1.48, CI 0.9-2.4); religion (Muslim women OR 3.15, CI 1.7-6.0 compared with Hindu women); women's concerns regarding their spouse's extramarital relationships (OR 3.46, CI 1.2-10.0); current BV infection (OR 1.87, CI 1.2-2.9); somatoform complaints (OR 3.30, CI 1.7-6.5 for the highest somatoform score quartile compared with the lowest); and depression and anxiety (OR 1.55, CI 0.9-2.6 for the highest mental health score quartile compared with the lowest). CONCLUSIONS: Reproductive and sexual health programmes must strengthen the capacity of practitioners to assess and treat bacterial vaginosis and psychosocial problems in women with complaints of abnormal vaginal discharge.

Gender disadvantage and reproductive health risk factors for common mental disorders in women: a community survey in India.

BACKGROUND: Gender disadvantage and reproductive health are major determinants of women's health in developing countries. OBJECTIVE: To determine the association of factors indicative of gender disadvantage and reproductive health with the risk of common mental disorders (CMDs) in women. DESIGN: Cross-sectional survey from November 1, 2001, to June 15, 2003. PARTICIPANTS: A total of 3000 women randomly selected from a sampling frame of women aged 18 to 45 years in Goa; 2494 women participated. MAIN OUTCOME MEASURES: The primary outcome was the presence of a CMD, as defined by the Revised Clinical Interview Schedule. An interview and blood and vaginal/urine specimens were collected to ascertain risk factors. RESULTS: The prevalence of CMD was 6.6% (95% confidence interval [CI], 5.7%-7.6%). Mixed anxiety-depressive disorder was the most common diagnosis (64.8%). Factors independently associated with the risk for CMD were factors indicative of gender disadvantage, particularly sexual violence by the husband (odds ratio [OR], 2.3; 95% CI, 1.1-4.6), being widowed or separated (OR, 5.4; 95% CI, 1.0-30.0), having low autonomy in decision making (OR, 1.98; 95% CI, 1.2-3.2), and having low levels of support from one's family (OR, 2.2; 95% CI, 1.4-3.3); reproductive health factors, particularly gynecological complaints such as vaginal discharge (OR, 3.2; 95% CI, 2.2-4.8) and dyspareunia (OR, 2.5; 95% CI, 1.4-4.6); and factors indicative of severe economic difficulties, such as hunger (OR, 2.7; 95% CI, 1.6-4.6). There was no association between biological indicators (anemia and reproductive tract infections) and CMD. CONCLUSIONS: The clinical assessment of CMD in women must include exploration of violence and gender disadvantage. Gynecological symptoms may be somatic equivalents of CMD in women in Asian cultures.

Chronic fatigue in developing countries: population based survey of women in India.

OBJECTIVES: To describe the prevalence of and risk factors for chronic fatigue in a developing country; in particular, to determine the association of anaemia, mental health, and gender disadvantage factors with chronic fatigue. DESIGN: Community survey. SETTING: Primary health centre catchment area in Goa, India. PARTICIPANTS: 3000 randomly sampled women aged 18 to 50 years. MAIN OUTCOME MEASURES: Data on the primary outcome (reporting of fatigue for at least six months) and psychosocial exposures elicited by structured interview; presence of anaemia determined from a blood sample. RESULTS: 2494 (83%) women consented to participate; 12.1% (95% confidence interval 10.8 to 13.4%) complained of chronic fatigue. In multivariate analyses, older women (P = 0.03) and those experiencing socioeconomic deprivation-less education (P < 0.001), families in debt (P = 0.09), or hunger in the past three months (P = 0.03)-were more likely to report chronic fatigue. After adjustment for these factors, factors indicating gender disadvantage (notably sexual violence by the husband; P < 0.001) and poor mental health (P < 0.001) were strongly associated with chronic fatigue. Although women with a high body mass index had a reduced risk, suggesting an influence of poor nutrition, no association was found between chronic fatigue and haemoglobin concentrations. CONCLUSIONS: Chronic fatigue was commonly reported by women in this community study from India. The strongest associations with chronic fatigue were for psychosocial factors indicative of poor mental health and gender disadvantage.

Why do women complain of vaginal discharge? A population survey of infectious and pyschosocial risk factors in a South Asian community.

BACKGROUND: Vaginal discharge is a common complaint, particularly among women in Asia. Although presumed to be caused by reproductive tract infections (RTIs), the association between the complaint and the presence of RTIs is weak. This study aimed to investigate the risk factors of the complaint of vaginal discharge. METHODS: We conducted a community-based survey of 3000 women aged 18-50 years, randomly sampled from a population in Goa, India. Women who gave informed consent were invited to participate in a structured interview, which elicited data on the primary outcome (the experience of current abnormal vaginal discharge) and psychosocial exposures: gender adversity; symptoms of somatoform disorders; and common mental disorders (CMD). All women were required to provide vaginal and/or urine samples for diagnosis of RTIs using gold standard laboratory tests. Risk factors were analysed using logistic regression with the binary outcome of the complaint of vaginal discharge. RESULTS: Of the 2494 women (83%) who agreed to participate, 14.5% complained of having an abnormal vaginal discharge. Stress was the most common causal attribution for the complaint. The final multivariate model found that high scores for CMD (OR 2.16, 1.4-3.2) and somatoform disorders (6.23, 4.0-9.7) and the use of an intrauterine contraceptive device (1.86, 1.0-3.4) were independently associated with the complaint. Low literacy (0.54, 0.4-0.8) and age >40 years (0.29, 0.2-0.4) were associated with a reduced risk. RTI were not associated with the complaint (1.24, 0.9-1.6). CONCLUSIONS: Psychosocial factors have the strongest association with the complaint of vaginal discharge. Syndromic management algorithms need refinement so that women with complaints that are non-infectious in aetiology are offered psychosocial interventions.