The phenomenological approach in dentistry - a narrative review.

PURPOSE: Phenomenology is a branch of philosophy that focuses on human lived experience. Illness including dental diseases can affect this living experience. Within the dental literature, there is very little reported on the use of phenomenology compared to other healthcare sciences. Hence, the aim was to review the literature and provide an overview of various applications of phenomenology in dental research. METHODS: This study was a narrative review using literature in the last 10 years identified by web-based search on PubMed and Scopus using keywords. A total of 33 articles that were closely related to the field and application in dentistry were included. The methodology, main results, and future research recommendations, if applicable, were extracted and reviewed. RESULTS: The authors in this study had identified several areas such as orofacial pain and pain control research, dental anxiety, dental education, oral healthcare perceptions and access, living with dental diseases and dental treatment experience in which the phenomenological method was used to gain an in-depth understanding of the topic. CONCLUSIONS: There are several advantages of using the phenomenological research method, such as the small sample size needed, the diverse and unique perspective that can be obtained and the ability to improve current understanding, especially from the first-person perspective.

Utilization of health insurance by patients admitted for dental surgical procedures at a tertiary care hospital in Coastal Karnataka: a retrospective study.

Background: There are various medical insurance options available in India. However, unlike many other countries, dental insurance plans are rare. The aim of this study was to assess the utilization of various government and private health insurance schemes by patients admitted for dental surgical procedures at a tertiary care hospital in coastal Karnataka, India. Methods: A study was conducted retrospectively to gather data on the socio-demographics, bill details, insurance, and benefits claimed by patients admitted to the Department of Oral and Maxillofacial Surgery at a tertiary care hospital from May 2016 to September 2022. Results: Out of 1750 patients, only 856 (48.9%) patients had availed of insurance, 395 patients (22.6%) utilized government health insurance policies, and 461 patients (26.3%) availed of private health insurance plans. Among Government schemes, primarily Ayushman Bharat-Arogya Karnataka was used by 262 (30.6%) patients, followed by Employees' State Insurance Scheme by 110 (12.9%) patients. Among private schemes, 212 (24.8%) patients used the policies purchased by them, 19 (2.2%) patients' medical expenses were paid by their employers, 105 (12.3%) patients utilized Manipal Arogya Suraksha and 124 (14.5%) patients used Medicare provided by the hospital. Bivariate linear regression confirmed that the total bill amount, out-of-pocket expenditure by the patient, and insurance amount reimbursed to the hospital were significantly associated with the type of insurance (government vs. private). The study noticed a gradual rise in insured patients every year. Conclusion: Greater utilization of health insurance should be encouraged because the cost of dental treatment has always hindered the use of oral health services worldwide. This study highlights that the benefit available to the patients were mainly through general health insurance schemes, not specifically dental health insurance. Insurance schemes covering dental must be promoted more aggressively in the media, highlighting their available benefits, merits, and demerits.

Pilot randomised controlled trial of a remotely delivered online intervention for adolescent mental health problems in India: lessons learned about low acceptability and feasibility during the COVID-19 pandemic.

BACKGROUND: 'POD Adventures' is a gamified problem-solving intervention delivered via smartphone app, and supported by non-specialist counsellors for a target population of secondary school students in India during the COVID-19 pandemic. AIMS: To evaluate the feasibility and acceptability of undertaking a randomised controlled trial of POD Adventures when delivered online with telephone support from counsellors. METHOD: We conducted a parallel, two-arm, individually randomised pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and 6 weeks post-randomisation. RESULTS: Seventy-nine classroom sensitisation sessions reaching a total of 1575 students were conducted. Ninety-two self-initiated study referrals (5.8%) were received, but only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at 6 weeks were not available for intervention arm participants (n = 5), and only four control arm participants completed outcomes. No qualitative interviews or participant satisfaction measures were completed because participants could not be reached by the study team. CONCLUSIONS: Despite modifications to address barriers arising from COVID-19 restrictions, online delivery was not feasible in the study context. Low recruitment and missing feasibility and acceptability data make it difficult to draw conclusions about intervention engagement and indicative clinical outcomes. Prior findings showing high uptake, adherence and engagement with POD Adventures when delivered in a school-based context suggest that an online study and delivery posed the biggest barriers to study participation and engagement.

Development of a cost of illness inventory questionnaire for children with autism spectrum disorder in South Asia.

BACKGROUND: The economic burden of autism is substantial and includes a range of costs, including healthcare, education, productivity losses, informal care and respite care, among others. In India, approximately, 2 million children aged 2-9 years have autism. Given the likely substantial burden of illness and the need to identify effective and cost-effective interventions, this research aimed to produce a comprehensive cost of illness inventory (COII) suitable for children with autism in South Asia (India) to support future research. METHODS: A structured and iterative design process was followed to create the COII, including literature reviews, interviews with caregivers, pilot testing and translation. Across the development of the COII, thirty-two families were involved in the design and piloting of the tool. The COII was forward translated (from English to Hindi) and back translated. Each stage of the process of development of the COII resulted in the further refinement of the tool. RESULTS: Domains covered in the final COII include education, childcare, relocation, healthcare contacts (outpatient, inpatient, medical emergencies, investigations and medication), religious retreats and rituals, specialist equipment, workshops and training, special diet, support and care, certification, occupational adjustments and government rebates/schemes. Administration and completion of the COII determined it to be feasible to complete in 35 minutes by qualified and trained researchers. The final COII is hosted by REDCap Cloud and is a bilingual instrument (Hindi and English). CONCLUSIONS: The COII was developed using experiences gathered from an iterative process in a metropolitan area within the context of one low- and middle-income country (LMIC) setting, India. Compared to COII tools used for children with autism in high-income country settings, additional domains were required, such as complimentary medication (e.g. religious retreats and homeopathy). The COII will allow future research to quantify the cost of illness of autism in India from a broad perspective and will support relevant economic evaluations. Understanding the process of developing the questionnaire will help researchers working in LMICs needing to adapt the current COII or developing similar questionnaires.

A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: "POD Adventures" is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE: Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS: We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. RESULTS: The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS: This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30339.

Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India.

INTRODUCTION: We evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems. METHODS: We conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents. RESULTS: Between 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001). CONCLUSION: A single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India. TRIAL REGISTRATION NUMBER: NCT03633916.

App-based guided problem-solving intervention for adolescent mental health: a pilot cohort study in Indian schools.

BACKGROUND: This paper describes the pilot evaluation of 'POD Adventures', a lay counsellor-guided problem-solving intervention delivered via a smartphone app in Indian secondary schools. OBJECTIVE: To test the feasibility and acceptability of POD Adventures for adolescents with a felt need for psychological support, and to explore the intervention's effects on self-reported mental health symptoms, prioritised problems, stress and well-being. METHODS: We used a mixed-methods pre-post cohort design. Participants were self-referred from grades 9-12 in two coeducational government-aided secondary schools in Goa, India. The intervention was delivered in two formats, 'mixed' (comprising individual and small group sessions) and 'group' (small group sessions only). FINDINGS: 248 participants enrolled in the study and 230 (92.7%) completed the intervention. Outcomes at 4 weeks showed significant improvements on all measures that were maintained at 12 weeks. Large effects were observed on problem severity scores (4 weeks, d=1.47; 12 weeks, d=1.53) while small to moderate effects were seen on mental health symptoms, stress and well-being. 22 students completed qualitative interviews about their experience of the intervention. Participants found POD Adventures easy to use, engaging and helpful in solving their problems. They were satisfied with the guidance provided by the counsellor irrespective of delivery format. CONCLUSIONS: POD Adventures was feasible to deliver with guidance from lay counsellors in Indian schools, acceptable to participants and associated with large improvements in problem severity and mental health symptom severity. CLINICAL IMPLICATIONS: POD Adventures has promise as an early intervention for adolescents with a felt need for psychological support in low-resource settings.

Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.

BACKGROUND: Mental health problems are a leading cause of disability in adolescents worldwide. Problem solving is a well-tested mental health intervention in many populations. We aimed to investigate the effectiveness of a brief, transdiagnostic problem-solving intervention for common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India. METHODS: This randomised trial was done in six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities. We recruited participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment. Clinical eligibility criteria were assessed by research assistants using the Hindi-language version of the Strengths and Difficulties Questionnaire (SDQ), with reference to locally validated borderline cutoff scores of 19 or greater for boys and 20 or greater for girls on the SDQ Total Difficulties scale, an abnormal score of 2 or more on the SDQ Impact scale, and persistence of more than 1 month on the SDQ Chronicity index. Participants were randomly allocated (1:1) to problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group). Primary outcomes were adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP]) at 6 weeks. Primary analyses were done on an intention-to-treat basis at the 6-week endpoint. The trial is registered with ClinicalTrials.gov, NCT03630471. FINDINGS: Participants were enrolled between Aug 20, and Dec 4, 2018. 283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys). 125 participants were allocated to each group (after accounting for one participant in the intervention group who withdrew consent after randomisation). Primary outcome data were available for 245 (98%) participants. At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61; p=0·0015). The mean SDQ Total Difficulties scores were 17·48 (5·45) in the intervention group and 18·33 (5·45) in the control group (-0·86, -2·14 to 0·41; 0·16, -0·09 to 0·41; p=0·18). We observed no adverse events. INTERPRETATION: A brief lay counsellor-delivered problem-solving intervention combined with printed booklets seemed to have a modest effect on psychosocial outcomes among adolescents with diverse mental health problems compared with problem-solving booklets alone. This counsellor-delivered intervention might be a suitable first-line intervention in a stepped care approach, which is being evaluated in ongoing studies. FUNDING: Wellcome Trust.

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.

Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools.

BACKGROUND: The PRIDE programme aims to establish a suite of transdiagnostic psychological interventions organised around a stepped care system in Indian secondary schools. This paper describes the development of a low-intensity, first-line component of the PRIDE model. METHOD: Contextual and global evidence informed an intervention 'blueprint' with problem solving as the primary practice element. Successive iterations were tested and modified across two pilot cohort studies (N = 45; N = 39). Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools. RESULTS: The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists. However, delivery was not feasible within the intended 6-week schedule, and participants struggled to use materials outside 'guidance' sessions. In Pilot 2, a modified counsellor-led problem-solving intervention was implemented by less experienced counsellors over a 3-4 week schedule. Outcomes were maintained, with indications of enhanced feasibility and acceptability. High demand was observed across both pilots, leading to more stringent eligibility criteria and a modified sensitisation plan. DISCUSSION: Findings have shaped a first-line intervention for common adolescent mental health problems in low-resource settings. A forthcoming randomised controlled trial will test its effectiveness.

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial.

BACKGROUND: Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial. METHODS/DESIGN: We will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding. DISCUSSION: Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems. TRIAL REGISTRATION: Both trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).

The prevalence, patterns, and correlates of gambling behaviours in men: An exploratory study from Goa, India.

BACKGROUND: There is a significant evidence gap on gambling in India, where gambling is viewed predominantly through the legal lens. The aim of this study is to determine the prevalence, patterns, and correlates of gambling. METHODS: Cross-sectional data from the follow-up assessment in a cohort (n = 1514 men) from India. The following data were collected using a structured questionnaire: socio-demographic information, gambling, interpersonal violence, tobacco use, alcohol use disorders (AUD), common mental disorders, and suicidality. Logistic regression models were used to examine the correlates of gambling. RESULTS: 658 participants (45.4%) reported gambling in the past year, and lottery was the most frequent form of gambling (67.8%). Current gambling was correlated with rural residence (OR 1.42, CI 1.05-1.93, p = 0.02), work-related problems (OR 1.42, CI 1.03-1.96, p = 0.03), interpersonal violence (OR 3.45, CI 1.22-9.75, p = 0.02), tobacco use (OR 1.59, CI 1.16-2.19, p = 0.004), and AUD (OR 2.14, CI 1.35-3.41, p = 0.001). 724 (49.9%) participants reported gambling at least once in their lifetime. Lifetime gambling was correlated with work-related problems (OR 1.57, CI 1.14-2.17, p = 0.006), interpersonal violence (OR 4.03, CI 1.32-12.30 p = 0.02), tobacco use (OR 1.60, CI 1.16-2.20, p = 0.004), and AUD (OR 2.12, CI 1.33-3.40, p = 0.002). Age was significantly associated with playing lottery more frequently (OR 3.24, CI 1.34-7.84, p = 0.009) and tobacco use was significantly associated with playing matka more frequently (OR 1.69, CI 1.08-2.64, p = 0.02). DISCUSSION: The high prevalence of gambling and its association with social problems and risk factors for non-communicable diseases warrants further epidemiological research.

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.

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.

Trajectories of Alcohol Use Disorders and Their Differential Impact: A Population-Based Cohort Study in Goa, India.

AIMS: The aim of this study was to examine trajectories of Alcohol Use Disorders (AUD) over a 6 year period and compare the bio-psycho-social correlates between these trajectories. METHODS: Community-based cohort of 1899 adult men were interviewed in 2006-2008 and 2012-2014. AUD were assessed using the Alcohol Use Disorder Identification Test, and potential correlates including psycho-social problems, morbidity and physiological parameters were measured at follow-up. Logistic regression was conducted to estimate odds ratios (ORs) for the association of persistent and incident AUD, respectively, with the potential correlates. Analyses were weighted to account for sampling design, number of adults aged 18-49 years in the household and non-response. RESULTS: Compared with men who had recovered from AUD, there was strong evidence (P < 0.001) that men with persistent AUD were more likely to have marital problems, tobacco use, and raised Gamma Glutamyl Transferase (GGT) and strong evidence (0.001 < P < 0.01) that they were more likely to have workplace problems, social problems, increased healthcare contact and raised Mean Corpuscular Volume (MCV). Compared with men who did not have AUD at baseline and follow-up, there was strong evidence (P < 0.001) that men with incident AUD were more likely to have workplace problems, social problems, marital problems, tobacco use, and raised GGT and strong evidence (0.001 < P < 0.01) that they were more likely to have hypertension, accident and injuries and Common Mental Disorders (CMD). CONCLUSION: This community-based longitudinal study of AUD, the first from a low and middle income country, clearly demonstrates significant health and social consequences of AUD in men and highlights the need for interventions for their treatment and prevention. SHORT SUMMARY: Compared to persistent AUD, recovery from AUD has several benefits in health and social domains. Compared to developing new AUD, not having AUD has several benefits in health and social domains. Sustaining the state of not having AUD or recovery can lead to accumulation of health and social capital over time.

The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

BACKGROUND: Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. METHODS: In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of <10) at 3 months in the intention-to-treat population, assessed by masked field researchers. Secondary outcomes were disability, days unable to work, behavioural activation, suicidal thoughts or attempts, intimate partner violence, and resource use and costs of illness. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISRCTN registry, number ISRCTN95149997. FINDINGS: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 495 participants (247 [50%] to the EUC plus HAP group [two of whom were subsequently excluded because of protocol violations] and 248 [50%] to the EUC alone group), of whom 466 (95%) completed the 3 month primary outcome assessment (230 [49%] in the EUC plus HAP group and 236 [51%] in the EUC alone group). Participants in the EUC plus HAP group had significantly lower symptom severity (Beck Depression Inventory version II in EUC plus HAP group 19·99 [SD 15·70] vs 27·52 [13·26] in EUC alone group; adjusted mean difference -7·57 [95% CI -10·27 to -4·86]; p<0·0001) and higher remission (147 [64%] of 230 had a PHQ-9 score of <10 in the HAP plus EUC group vs 91 [39%] of 236 in the EUC alone group; adjusted prevalence ratio 1·61 [1·34-1·93]) than did those in the EUC alone group. EUC plus HAP showed better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; p<0·0001), and suicidal thoughts or attempts (0·61 [0·45-0·83]; p=0·001). The incremental cost per quality-adjusted life-year gained was $9333 (95% CI 3862-28 169; 2015 international dollars), with an 87% chance of being cost-effective in the study setting. Serious adverse events were infrequent and similar between groups (nine [4%] in the EUC plus HAP group vs ten [4%] in the EUC alone group; p=1·00). INTERPRETATION: HAP delivered by lay counsellors plus EUC was better than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. FUNDING: Wellcome Trust.

Counselling for Alcohol Problems (CAP), a lay counsellor-delivered brief psychological treatment for harmful drinking in men, in primary care in India: a randomised controlled trial.

BACKGROUND: Although structured psychological treatments are recommended as first-line interventions for harmful drinking, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of Counselling for Alcohol Problems (CAP), a brief psychological treatment delivered by lay counsellors to patients with harmful drinking attending routine primary health-care settings. METHODS: In this randomised controlled trial, we recruited male harmful drinkers defined by an Alcohol Use Disorders Identification Test (AUDIT) score of 12-19 who were aged 18-65 years from ten primary health centres in Goa, India. We excluded patients who needed emergency medical treatment or inpatient admission, who were unable to communicate clearly, and who were intoxicated at the time of screening. Participants were randomly allocated (1:1) by trained health assistants based at the primary health centres to enhanced usual care (EUC) alone or EUC combined with CAP, in randomly sized blocks of four to six, stratified by primary health centre, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC and those assessing outcomes were masked. Primary outcomes were remission (AUDIT score of <8) and mean daily alcohol consumed in the past 14 days, at 3 months. Secondary outcomes were the effect of drinking, disability score, days unable to work, suicide attempts, intimate partner violence, and resource use and costs of illness. Analyses were on an intention-to-treat basis. We used logistic regression analysis for remission and zero-inflated negative binomial regression analysis for alcohol consumption. We assessed serious adverse events in the per-protocol population. This trial is registered with the ISCRTN registry, number ISRCTN76465238. FINDINGS: Between Oct 28, 2013, and July 29, 2015, we enrolled and randomly allocated 377 participants (188 [50%] to the EUC plus CAP group and 190 [50%] to the EUC alone group [one of whom was subsequently excluded because of a protocol violation]), of whom 336 (89%) completed the 3 month primary outcome assessment (164 [87%] in the EUC plus CAP group and 172 [91%] in the EUC alone group). The proportion with remission (59 [36%] of 164 in the EUC plus CAP group vs 44 [26%] of 172 in the EUC alone group; adjusted prevalence ratio 1·50 [95% CI 1·09-2·07]; p=0·01) and the proportion abstinent in the past 14 days (68 [42%] vs 31 [18%]; adjusted odds ratio 3·00 [1·76-5·13]; p<0·0001) were significantly higher in the EUC plus CAP group than in the EUC alone group, but we noted no effect on mean daily alcohol consumed in the past 14 days among those who reported drinking in this period (37·0 g [SD 44·2] vs 31·0 g [27·8]; count ratio 1·08 [0·79-1·49]; p=0·62). We noted an effect on the percentage of days abstinent in the past 14 days (adjusted mean difference [AMD] 16·0% [8·1-24·1]; p<0·0001), but no effect on the percentage of days of heavy drinking (AMD -0·4% [-5·7 to 4·9]; p=0·88), the effect of drinking (Short Inventory of Problems score AMD-0·03 [-1·93 to 1·86]; p=0.97), disability score (WHO Disability Assessment Schedule score AMD 0·62 [-0·62 to 1·87]; p=0·32), days unable to work (no days unable to work adjusted odds ratio 1·02 [0·61-1·69]; p=0.95), suicide attempts (adjusted prevalence ratio 1·8 [-2·4 to 6·0]; p=0·25), and intimate partner violence (adjusted prevalence ratio 3·0 [-10·4 to 4·4]; p=0·57). The incremental cost per additional remission was $217 (95% CI 50-1073), with an 85% chance of being cost-effective in the study setting. We noted no significant difference in the number of serious adverse events between the two groups (six [4%] in the EUC plus CAP group vs 13 [8%] in the EUC alone group; p=0·11). INTERPRETATION: CAP delivered by lay counsellors plus EUC was better than EUC alone was for harmful drinkers in routine primary health-care settings, and might be cost-effective. CAP could be a key strategy to reduce the treatment gap for alcohol use disorders, one of the leading causes of the global burden among men worldwide. FUNDING: Wellcome Trust.

The six-year outcome of alcohol use disorders in men: A population based study from India.

BACKGROUND: Despite the large and growing public health problem of alcohol use disorders (AUD) in India there is a dearth of evidence about the longitudinal outcomes in AUD. The aim of this study is to describe the course and outcomes of AUD in a population based sample of men in India. METHODS: A community cohort of 1899 adult (18-49 years at baseline) men who participated in a cross-sectional survey in Goa, India between 2006 and 08, were re-interviewed face to face 6 years later (2012-14). A range of outcomes including social problems (e.g., workplace problems, domestic violence), morbidity (e.g., range of physical and mental health problems), biological parameters (e.g., mean corpuscular volume [MCV], gamma-glutamyl transpeptidase [GGT]) and mortality were measured at follow up. For the association of AUD at baseline with outcomes at follow-up, multivariable logistic regression was used to estimate odds ratios (OR). Analyses were weighted to account for baseline sampling design, age distribution, rural and urban sample sizes, number of adults aged 18-49 years in the household (at baseline), and non-response (at baseline). RESULTS: 1514 (79.7%) were seen at follow-up; a loss to follow up of 20.3%. At follow up, 3.7% of baseline non-drinkers and 15.0% of baseline casual drinkers had AUD. 46.9% of baseline hazardous drinkers and 55.4% baseline harmful drinkers continued to have AUD at follow up. Of those with AUD at baseline, 21.8% had stopped drinking at follow-up. Compared to being abstinent, harmful drinking at baseline was associated with several outcomes at follow-up: workplace/social problems, hypertension, death, tobacco use, suicidality, anxiety disorders, and raised GGT (p<0.002). Hazardous drinking at baseline was associated with tobacco use and raised GGT and MCV (p<0.002) at follow-up. CONCLUSION: Our findings of high persistent and new AUD in the community and the association with a range of long term adverse events are an important addition to the limited evidence about the course and outcomes of AUD in India, which have the potential for informing health policy.

The systematic development and pilot randomized evaluation of counselling for alcohol problems, a lay counselor-delivered psychological treatment for harmful drinking in primary care in India: the PREMIUM study.

BACKGROUND: Despite harmful drinking causing a significant burden on global health, there is a large treatment gap, especially in low- and middle-income countries. A major barrier to care is the lack of adequately skilled human resources to deliver contextually appropriate treatments. This paper describes the systematic process used to develop Counselling for Alcohol Problems (CAP), a brief psychological treatment (PT) for delivery by lay counselors in routine primary care settings to men with harmful drinking in India. METHODS: CAP was developed using a methodology involving 3 sequential steps: (i) identifying potential treatment strategies; (ii) developing a theoretical framework for the treatment; and (iii) evaluating the acceptability and feasibility of the treatment. RESULTS: CAP is a 3-phase treatment delivered over 1 to 4 sessions based on a motivational interviewing (MI) stance and involves the following strategies: assessment and personalized feedback, family engagement, drink refusal skills, skills to address drinking urges, problem-solving skills and handling difficult emotions, and relapse prevention and management. Data from a case series were used to inform several adaptations to enhance the acceptability of CAP to the recipients and feasibility of delivery by lay counselors of the treatment, for example expansion of the target group to include alcohol-dependent patients and the extension of the delivery settings to include home-based delivery. There was preliminary evidence of the effectiveness of CAP. CONCLUSIONS: CAP is an acceptable brief PT for harmful drinking delivered by lay counselors in primary care whose effectiveness is currently being tested in a randomized controlled trial based in primary care in Goa, India.