Sociodemographic and Behavioral Factors Associated With Hypertension and Depression in 4 Rural Communities in Northern Ghana: A Cross-Sectional Study.

OBJECTIVES: The prevalences of hypertension and depression in sub-Saharan Africa are substantial and rising, despite limited data on their sociodemographic and behavioral risk factors and their interactions. We undertook a cross-sectional study in 4 communities in the Upper East Region of Ghana to identify persons with hypertension and depression in the setting of a pilot intervention training local nurses and health volunteers to manage these conditions. METHODS: We quantified hypertension and depression prevalence across key sociodemographic factors (age, sex, occupation, education, religion, ethnicity, and community) and behavioral factors (tobacco use, alcohol use, and physical activity) and tested for association by multivariable logistic regression. RESULTS: Hypertension prevalence was higher in older persons (7.6% among 35- to 50-year-olds vs 16.4% among 51- to 70-year-olds) and among those reporting alcohol use (18.9% vs 8.5% between users and nonusers). In multivariable models, only older age (AOR 2.39 [1.02, 5.85]) and residence in the community of Wuru (AOR 7.60 [1.81, 32.96]) were independently associated with hypertension, and residence in Wuru (AOR 23.58 [7.75-78.25]) or Navio (AOR 7.41 [2.30-24.74]) was the only factor independently associated with depression. CONCLUSIONS: We report a high prevalence of both diseases overall and in select communities, a trend that requires further research to inform targeted chronic disease interventions.

Balancing Ethics and Culture: A Scoping Review of Ethico-Cultural and Implementation Challenges of the Individual-Based Consent Model in African Research.

Objective: This review explores the ethico-cultural and implementation challenges associated with the individual-based informed consent (IC) model in the relatively collectivistic African context and examines suggested approaches to manage them. Methods: We searched four databases for peer-reviewed studies published in English between 2000 to 2023 that examined the ethico-cultural and implementation challenges associated with the IC model in Africa. Results: Findings suggest that the individual-based IC model largely misaligns with certain African social values and ethos and subverts the authority and functions of community gatekeepers. Three recommendations were proffered to manage these challenges, that researchers should: adopt a multi-step approach to IC, conduct a rapid ethical assessment, and generate an African-centered IC model. Conclusions: A pluriversal, context-specific, multi-step IC model that critically harmonizes the cultural values of the local population and the general principles of IC can minimize ethics dumping, safeguard the integrity of the research process, and promote respectful engagement.

Factor structure of the alcohol expectancies questionnaire among adolescents in rural Ghana.

INTRODUCTION: Children's early experiences with alcohol inform the development of alcohol-related beliefs which are known to predict alcohol consumption during the critical stage of adolescence. Yet, there has been considerably less research into these alcohol-related cognitions in low- and middle-income countries (LMIC) and existing measures of these beliefs are highly reflective of Western contexts, which may not be fully appropriate for use in LMICs. The aim is to ascertain the construct validity of the Alcohol Expectancies Questionnaire (AEQ) in a non-Western sample. METHODS: A cross-sectional diagnostic accuracy study involving 500 adolescents aged 10 to 18 years randomly selected from the database of the Navrongo Health and Demographic Surveillance System. Participants were administered the locally back translated version of the 34-item AEQ. Confirmatory factor analysis using the lavaan package in R was conducted to generate indices for the factor structure of the AEQ. RESULTS: Confirmatory factor analyses showed that while groupings of positive and negative expectancies were similar to those observed when expectancies have been assessed previously in Western studies, these formed a single 'alcohol expectancy' factor. Questions relating to positive tension reduction and negative physical expectancies showed inconsistent responses in this study. DISCUSSION AND CONCLUSIONS: Commonly used tools for the assessment of alcohol expectancies may not be suitable for use in Ghana, possibly owing to their development and validation in Western contexts. These findings have implications for the assessment of alcohol-related beliefs in LMIC settings and begin to map out a research agenda to develop more contextually and culturally attune alcohol assessments.

Mental health and disability research in Ghana: a rapid review.

The objective of this rapid review was to explore the current evidence base for mental health and disability research in Ghana. The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist was followed. Online databases were used to identify primary studies, systematic reviews, meta-analyses, rapid reviews, or guidelines published between 2010 and 2020. All relevant published (both peer-reviewed articles and grey literature) on mental health and/or disability research conducted in or on Ghana between 2010 and 2020 were included in this review. 4,791 articles were identified in the initial search. After the removal of duplicates, followed by title and abstract screening, 930 articles were selected for full-text review. An additional 8 articles identified from reference lists of included articles were also included in full-text review. After review, 375 articles were selected for inclusion; 234 (62%) were on mental health while the remaining 141 (38%) were on disability. There is an increasing trend in the absolute number of mental health and/or disability studies. Most of the mental health studies included in this review were either observational quantitative studies (n=132; 56%) or observational qualitative studies (n=79; 34%). There were very few interventional studies (n=6; 3%). A similar finding was noted for the disability studies. External funding accounted for 51% of mental health articles. Although there was a steady year-on-year increase in the absolute number of mental health and/or disability studies conducted between 2010 to 2020, there is a need for more intervention studies to evaluate what mental health and/or disability interventions work, for whom, and under what circumstances. These should include evaluations of the cost, benefits, effectiveness, and acceptability of various interventions for policy and planning. Further, there is a need for the Ministry of Health to prioritize research funding for mental health and disability and enhance technical and methodological capacity of researchers to conduct disability and mental health research in Ghana.

Predictors of spontaneous remission and recovery among women with untreated perinatal depression in India and Pakistan.

Background: Mothers with perinatal depression can show different symptom trajectories and may spontaneously remit from depression, however, the latter is poorly understood. This is the first study which sought to investigate predictors of spontaneous remission and longer-term recovery among untreated women with perinatal depression. Methods: We analysed data from two randomised controlled trials in women with perinatal depression in India and Pakistan. Analyses were restricted to women in the control groups who did not receive active treatment. Generalised estimating equations and logistic regressions were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs), adjusting for within-person correlation. Results: In multivariable analyses, remission was associated with a husband who is not working (adjusted OR, aOR = 2.04, 95% CI 1.02-4.11), lower Patient Health Questionnaire-9 score at baseline (aOR = 0.43, 95% CI 0.20-0.90 for score of ≥20 vs. 10-14) and better social support at baseline (aOR = 2.37, 95% CI 1.32-4.27 for high vs. low social support). Conclusions: Women with low baseline severity may remit from perinatal depression with adequate social support from family and friends. These factors are important contributors to the management of perinatal depression and the prevention of clinical worsening, and should be considered when designing low-threshold psychological interventions.

Towards implementation of context-specific integrated district mental healthcare plans: A situation analysis of mental health services in five districts in Ghana.

BACKGROUND: Access to quality mental health services in Ghana remains poor, yet little is known about the extent of the access gaps and provision of mental health services at the district level in Ghana. We aimed to conduct an analysis of mental health infrastructure and service provision in five districts in Ghana. METHODS: A cross-sectional situation analysis was conducted using a standardised tool to collect secondary healthcare data, supplemented by interviews with key informants, across five purposively selected districts in Ghana. The Programme for Improving Mental Health Care (PRIME) situation analysis tool was adapted to the Ghanaian context and used for data collection. RESULTS: The districts are predominantly rural (>60%). There were severe challenges with the provision of mental healthcare: there were no mental healthcare plans, supervision of the few mental health professionals was weak and unstructured, access to regular supplies of psychotropic medications was a major challenge, and psychological treatments were extremely limited given the lack of trained clinical psychologists. There were no available data on treatment coverage, but we estimate this to be <1% for depression, schizophrenia, and epilepsy across districts. Opportunities for mental health systems strengthening include: the commitment and willingness of leadership, the existence of the District Health Information Management System, a well-established network of community volunteers, and some collaboration with traditional and faith-based mental health service providers. CONCLUSION: There is poor mental health infrastructure across the five selected districts of Ghana. There are opportunities for strengthening mental health systems through interventions at the district healthcare organisation, health facility, and community levels. A standardised situation analysis tool is useful for informing district-level mental healthcare planning in low-resource settings in Ghana and potentially other sub-Saharan African countries.

Prevalence of probable mental, neurological and substance use conditions and case detection at primary healthcare facilities across three districts in Ghana: findings from a cross-sectional health facility survey.

BACKGROUND: Few studies have examined the prevalence of mental, neurological and substance use (MNS) conditions, case detection and treatment in primary healthcare in rural settings in Africa. We assessed prevalence and case detection at primary healthcare facilities in low-resource rural settings in Ghana. METHODS: A cross-sectional survey was conducted at the health facility level in three demonstration districts situated in Bongo (Upper East Region), Asunafo North (Ahafo Region) and Anloga (Volta Region) in Ghana. The study participants were resident adult (> 17 years) out-patients seeking healthcare at primary care facilities in each of the three demonstration districts. Data were collected on five priority MNS conditions: depression, psychosis, suicidal behaviour, epilepsy and alcohol use disorders. RESULTS: Nine hundred and nine (909) people participated in the survey. The prevalence of probable depression was 15.6% (142/909), probable psychotic symptoms was 12% (109/909), probable suicidal behaviour was 11.8% (107/909), probable epilepsy was 13.1% (119/909) and probable alcohol use disorders was 7.8% (71/909). The proportion of missed detection for cases of depression, self-reported psychotic symptoms, epilepsy and alcohol use disorders (AUD) ranged from 94.4 to 99.2%, and was similar across study districts. Depression was associated with self-reported psychotic symptoms (RR: 1.68; 95% CI: 1.12-1.54). For self-reported psychotic symptoms, a reduced risk was noted for being married (RR: 0.62; 95% CI: 0.39-0.98) and having a tertiary level education (RR: 0.12; 95% CI: 0.02-0.84). Increased risk of suicidal behaviour was observed for those attending a health facility in Asunafo (RR: 2.31; 95% CI: 1.27-4.19) and Anloga districts (RR: 3.32; 95% CI: 1.93-5.71). Age group of 35 to 44 years (RR: 0.43; 95% CI: 0.20-0.90) was associated with reduced risk of epilepsy. Being female (RR: 0.19; 95% CI: 0.12-0.31) and having a tertiary education (RR: 0.27; 95% CI: 0.08-0.92) were associated with reduced risk of AUD. CONCLUSIONS: Our study found a relatively high prevalence of probable MNS conditions, and very low detection and treatment rates in rural primary care settings in Ghana. There is a need to improve the capacity of primary care health workers to detect and manage MNS conditions.

Mental health and disability research priorities and capacity needs in Ghana: findings from a rapid review and research priority ranking survey.

BACKGROUND: Identification of national research agendas for mental health and disability can be supported by well-designed research priority-setting studies. Few low- and middle-income countries (LMICs) have undertaken such studies. OBJECTIVE: To identify mental health and disability research priorities in Ghana. METHODS: A mixed methods study comprising a rapid review, research priority ranking survey, and research capacity needs assessment survey was employed. Participants in the surveys included five expert pools identified from online search and existing database on mental health civil society organisations/non-governmental organisations. The research priority ranking was completed in two stages, using the Child and Nutrition Research Initiative (CHNRI) method to identify priority questions for immediate and short term (0 to 5 years) and medium to long term (>5 years) in stage two. Both surveys were deployed online using google forms. Analysis for the ranking survey involved computing total scores from the CHNRI criteria and generating ranks for the research questions. RESULTS: A total of 68 experts (97% response rate), generated 94 and 92 questions for the short and long term, respectively. Forty experts (58% response rate) completed the ranking stage. The top 10 ranked research questions included: 4 questions addressing health systems; 2 questions on epidemiology; and 4 questions on interventions. All research questions were considered urgent and should be conducted in the immediate to short term (0-5 years). The methodological capacity of researchers to conduct disability and mental health research is weak. CONCLUSION: Our approach has generated an agenda for mental health and disability research priorities for Ghana and demonstrated that it is feasible to employ a systematic methodology for research priority setting that includes key parameters of context and research capacity.

Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan.

BACKGROUND: The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers. THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates. METHODS: Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only. Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth. Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth. RESULTS: Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up. Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes. LIMITATIONS: The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data. CONCLUSIONS: This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.

Temporal pathways of change in two randomized controlled trials for depression and harmful drinking in Goa, India.

BACKGROUND: The current study explored the temporal pathways of change within two treatments, the Healthy Activity Program (HAP) for depression and the Counselling for Alcohol Problems (CAP) Program for harmful drinking. METHODS: The study took place in the context of two parallel randomized controlled trials in Goa, India. N = 50 random participants who met a priori criteria were selected from each treatment trial and examined for potential direct and mediational pathways. In HAP, we examined the predictive roles of therapy quality and patient-reported activation, assessing whether activation mediated the effects of therapy quality on depression (Patient Health Questionnaire-9) outcomes. In CAP, we examined the predictive roles of therapy quality and patient change- and counter-change-talk, assessing whether change- or counter-change-talk mediated the effects of therapy quality on daily alcohol consumption. RESULTS: In HAP, therapy quality (both general and treatment-specific skills) was associated with patient activation; patient activation but not therapy quality significantly predicted depression outcomes, and patient activation mediated the effects of higher general skills on subsequent clinical outcomes [a × b = -2.555, 95% confidence interval (CI) -5.811 to -0.142]. In CAP, higher treatment-specific skills, but not general skills, were directly associated with drinking outcomes, and reduced levels of counter-change talk both independently predicted, and mediated the effects of higher general skills on, reduced alcohol consumption (a × b = -24.515, 95% CI -41.190 to -11.060). Change talk did not predict alcohol consumption and was not correlated with counter-change talk. CONCLUSION: These findings suggest that therapy quality in early sessions operated through increased patient activation and reduced counter-change talk to reduce depression and harmful drinking respectively.

Psychological treatments for depression among women experiencing intimate partner violence: findings from a randomized controlled trial for behavioral activation in Goa, India.

Intimate partner violence (IPV) strongly predicts depression, but it is unknown if women experiencing IPV can benefit from depression treatments in contexts where depression and IPV are prevalent. This study explored whether women experiencing IPV in Goa, India, can benefit from the Healthy Activity Program (HAP), a culturally adapted behavioral activation treatment, compared with enhanced usual care (EUC). Cross-sectional and longitudinal analyses were performed on data from a clinical trial. Measures assessed at baseline and 3 and 12 months included depressive symptoms. Measures assessed at 3 and 12 months included activation and IPV. Independent t tests were conducted to assess if participants experiencing IPV had higher depressive symptoms and lower activation at 3 and 12 months; hierarchical linear regression was conducted to determine if 3-month IPV predicted 12-month depressive symptoms across trial arms (Hypothesis 1). Hierarchical linear regression was then conducted to examine if the relationship between 3-month activation and 12-month depressive symptoms was moderated by 3-month IPV within each trial arm (Hypothesis 2). As expected, participants experiencing IPV had significantly lower activation levels and higher depressive symptoms compared with participants who did not experience IPV at 3 and 12 months in cross-sectional analyses. Similarly, IPV endorsed at 3 months significantly predicted depressive symptoms at 12 months. However, activation was significantly associated with less severe depressive symptoms at 12 months, irrespective of IPV endorsement among HAP participants. For EUC participants, IPV remained the only significant predictor of depressive symptoms at 12 months. Results suggest that women experiencing IPV can still benefit from behavioral activation.

Auditing the AUDIT: A systematic review of cut-off scores for the Alcohol Use Disorders Identification Test (AUDIT) in low- and middle-income countries.

INTRODUCTION: The World Health Organization's (WHO) Alcohol Use Disorders Identification Test (AUDIT) is used extensively across the world, with cut-off scores recommended by the WHO. We reviewed the use and validity of AUDIT cut-off scores in low- and middle-income countries as cultural contexts are expected to influence the detection of alcohol use disorders. MATERIALS AND METHODS: The systematic review was guided by an a priori defined protocol consistent with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. We searched Cochrane library, Medline, EMBASE, PsycINFO, CINAHL, Indmed, LILACS, and AJOL databases using appropriate search terms. We conducted a narrative synthesis of the data. RESULTS: We identified 54 distinct studies that used AUDIT cut-off scores which were not in alignment with those recommended by the WHO. India (n = 10), Nigeria (n = 9), and Brazil (n = 9) produced most of these included studies. Most of the studies (n = 42) did not conduct psychometric evaluations of AUDIT cut-off scores. Of the twelve studies which did report psychometric results, a wide range of cut-off scores performed well. In these studies the cut-off scores to detect hazardous drinking ranged from >3 to >5, for harmful drinking from >5 to >16, and for dependent drinking from >7 to >24. DISCUSSION: AUDIT is being widely used in LMICs and non-recommended cut-off scores are considered to be appropriate in these countries. It is important to systematically evaluate the psychometric properties of those cut-off scores to ensure the internal validity of the studies in which they are used.

Feasibility, acceptability and cost-effectiveness of a brief, lay counsellor-delivered psychological treatment for men with alcohol dependence in primary care: an exploratory randomized controlled trial.

AIMS: To examine the feasibility, acceptability and preliminary cost-effectiveness of a lay counsellor delivered psychological treatment for men with alcohol dependence in primary care. DESIGN: Single-blind individually randomized trial comparing counselling for alcohol problems (CAP) plus enhanced usual care (EUC) versus EUC only. SETTING: Ten primary health centres in Goa, India. PARTICIPANTS: Men (n = 135) scoring ≥ 20 on the Alcohol Use Disorder Identification Test (AUDIT). Sixty-six participants were randomized to EUC and 69 to CAP + EUC. INTERVENTIONS: CAP, a lay counsellor-delivered psychological treatment for harmful drinking, with referral to de-addiction centre for medically assisted detoxification. EUC comprised consultation with physician, providing screening results and referral to a de-addiction centre. MEASUREMENTS: Baseline socio-demographic data, readiness to change and perceived usefulness of counselling. Acceptability and feasibility process indicators such as data on screening and therapy. Outcomes were measured at 3 and 12 months post-randomization and included remission, mean daily alcohol consumed, percentage of days abstinent (PDA), percentage of days of heavy drinking (PDHD), recovery, uptake of detoxification services, impacts of alcohol dependence, resource use and costs. FINDINGS: Participants in the CAP + EUC arm had more numerically but not statistically significantly favourable outcomes compared with those in the EUC arm for (a) remission at 3 months [adjusted odds ratio (aOR) = 1.95, 95% confidence interval (CI) = 0.74-5.15] and 12 months (aOR = 1.90, 95% CI = 0.72-5.00), (b) proportion of non-drinkers at 3 months (aOR = 1.26; 95% CI = 0.58-2.75) and 12 months (aOR = 1.25; 95% CI = 0.58-2.64) and (c) ethanol consumption among drinkers at 3 months (count ratio = 0.91; 95% CI = 0.58-1.45) and 12 months (count ratio = 1.06; 95% CI = 0.73-1.54). There was no statistically significant evidence of a difference in the occurrence of serious adverse events between the two arms. From a societal perspective, there was a 53% chance of CAP + EUC being cost-effective in achieving remission at 12 months at the willingness-to-pay threshold of $415. CONCLUSIONS: Lay counsellor-delivered psychological treatment for men with alcohol dependence (AD) in primary care may be effective in managing AD in low- and middle-income countries. A definitive trial of the intervention is warranted.

Delivering the Thinking Healthy Programme for perinatal depression through peers: an individually randomised controlled trial in India.

BACKGROUND: The Thinking Healthy Programme (THP) is a psychological intervention recommended for the treatment of perinatal depression. However, efforts to integrate the intervention at scale into the routines of community health workers who delivered the THP when it was first evaluated were compromised by the competing responsibilities of community health workers. We aimed to assess the effectiveness and cost-effectiveness of THP peer-delivered (THPP) in Goa, India. METHODS: In this single-blind, individually randomised controlled trial, we recruited pregnant women aged 18 years or older who scored at least 10 on the Patient Health Questionnaire-9 (PHQ-9) from antenatal clinics in Goa. Participants were randomly allocated (1:1) to receive enhanced usual care (EUC; so-called because, in India, perinatal depression is not typically treated) only (control group) or THPP in addition to EUC (intervention group) in randomly sized blocks that were stratified by area of residence (urban or rural). Group allocations were concealed from participants and researchers before assignments were made by use of sequentially numbered opaque envelopes. The primary outcomes were the severity of depressive symptoms (assessed by PHQ-9 score) and the prevalence of remission (defined as a PHQ-9 score of less than 5) in participants with available data 6 months after childbirth, which was assessed by researchers who were masked to treatment allocations. We analysed outcomes by intention to treat, adjusting for covariates that were defined a priori or that showed imbalance at baseline. The trial is registered with ClinicalTrials.gov, number NCT02104232. FINDINGS: Between Oct 24, 2014, and June 24, 2016, we assessed 118 260 women for their eligibility for screening, of whom 111 851 (94·6%) women were ineligible. 6409 (5·4%) women were eligible for screening and 6369 (99·4%) of these women consented to be screened with the PHQ-9 (40 women did not consent), of whom 333 (5·2%) screened positive for depression (defined as a PHQ-9 score of at least 10). We enrolled 280 (84·1%) women with perinatal depression; 140 women were assigned to the THPP and EUC group and 140 women to the EUC only group. The final treatment was given on May 27, 2017. The final 6-month outcome assessment was completed on June 9, 2017. At 6 months after birth, 122 (87%) women in the THPP and EUC group and 129 (92%) women in the EUC only group were assessed for the primary outcome. There was a higher prevalence of remission at 6 months after birth in the THPP and EUC group compared with the EUC only group (89 [73%] women in the intervention group vs 77 [60%] women in the control group; prevalence ratio 1·21, 95% CI 1·01 to 1·45; p=0·04), but there was no evidence of a difference in symptom severity between the groups (mean PHQ-9 score 3·47 [SD 4·49] in the intervention group vs 4·48 [5·11] in the control group; standardised mean difference -0·18, 95% CI -0·43 to 0·07; p=0·16). There was no evidence of significant differences in serious adverse events between the groups. INTERPRETATION: THPP had a moderate effect on remission from perinatal depression over the 6-month postnatal period. THPP is relatively cheap to deliver and is cost-saving through reduced health-care, time and productivity costs. FUNDING: National Institute of Mental Health (USA).

Psychometric properties of the AUDIT among men in Goa, India.

AIMS: The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening questionnaire used to detect alcohol use disorders. The AUDIT has been validated in only two studies in India and although it has been previously used in Goa, India, it has yet to be validated in that setting. In this paper, we aim to report data on the validity of the AUDIT for the screening of AUDs among men in Goa, India. METHODS: Concurrent and convergent validity of the AUDIT were assessed against the Mini International Neuropsychiatric Interview (MINI) and World Health Organisation Disability Assessment Scale (WHODAS) for alcohol abuse, alcohol dependence, and functional status respectively through the secondary analysis of data from a community cohort of men from Goa, India. RESULTS: The AUDIT showed high internal reliability and acceptable criterion validity with adequate psychometric properties for the detection of alcohol abuse and dependence. However, all of the optimal cut-off points from ROC analyses were lower than the WHO recommended for identification of risk of all AUDs, with a score of 6-12 detecting alcohol abuse and 13 and higher alcohol dependence. CONCLUSIONS: In order to optimize the utility of the AUDIT, a lowered cut-off point for alcohol abuse and dependence is recommended for Goa, India. Further validation studies for the AUDIT should be conducted for continued validation of the tool in other parts of India.

Sustained effectiveness and cost-effectiveness of Counselling for Alcohol Problems, a brief psychological treatment for harmful drinking in men, delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

BACKGROUND: Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator 'readiness to change' on clinical outcomes. METHODS AND FINDINGS: Male primary care attendees aged 18-65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]). Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample. CONCLUSIONS: CAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective. TRIAL REGISTRATION: ISRCTN registry ISRCTN76465238.

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial.

BACKGROUND: The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. METHODS AND FINDINGS: Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060-equivalent to GDP per capita in Goa-per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (ß = -2.62; 95% CI -3.28, -1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation. CONCLUSIONS: HAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families. TRIAL REGISTRATION: ISRCTN registry ISRCTN95149997.

The psychometric properties of GHQ for detecting common mental disorder among community dwelling men in Goa, India.

BACKGROUND: There have not been many attempts to validate screening measures for common mental disorders (CMD) in low- and middle-income countries. The aim of this study was to examine the criterion validity of the General Health Questionnaire 12 (GHQ-12) in a community-based study from Goa, India. METHOD: Concurrent and convergent validity of the GHQ-12 were assessed against the Mini International Neuropsychiatric Interview (MINI) and World Health Organization Disability Assessment Scale (WHODAS) for CMD and functional status through the secondary analysis of a community cohort of men from Goa, India. Criterion validity of the GHQ-12 was determined using ROC analyses with the MINI case criterion as the gold standard. Concurrent validity was assessed against the gold standard of WHODAS functional disability and number of disability days. RESULTS: In a sample of men (n=773), the GHQ-12 showed high internal reliability (Cronbach's alpha of 0.82) and acceptable criterion validity (Area under the receiver operating characteristic curve being 0.71). It had adequate psychometric properties for the detection of CMD (sensitivity of 68.75%; specificity of 73.14%) with the optimal cut-off score for identification of CMD being 2. CONCLUSION: In order to optimize the usefulness and validity of the GHQ-12, a low cut-off point for CMD may be beneficial in Goa, India. Further validation studies for the GHQ-12 should be conducted for continued validation of the test for use in the community.