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
            <scp>PREMIUM</scp>
            Study

Nadkarni, Abhijit; Velleman, Richard; Dabholkar, Hamid; Shinde, Sachin; Bhat, Bhargav; McCambridge, Jim; Murthy, Pratima; Wilson, Terry; Weobong, Benedict; Patel, Vikram

doi:10.1111/acer.12653

Cited by 47 publications

(70 citation statements)

References 34 publications

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“…Brief intervention does not require specialist skills and can be provided by any credible health care provider. An Indian study is exploring use of lay counsellors 108 and if successful, will allow widespread dissemination of this intervention at lower cost. Many alcohol brief interventions have been made available online in recent years but are largely in the English language to date.…”

Section: Treatment Of Audmentioning

confidence: 99%

Alcoholic Liver Disease in Asia, Europe, and North America

2016

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Alcoholic liver diseases (ALD) comprise a spectrum of clinical disorders and changes in liver tissue that can be detected by pathology analysis. These range from steatosis to more severe signs and symptoms of liver disease associated with inflammation, such as those observed in patients with alcoholic hepatitis or cirrhosis. Although the relationship between alcohol consumption and liver disease is well established, severe alcohol-related morbidities develop in only a minority of people who consume alcohol in excess. Inter-individual differences in susceptibility to the toxic effects of alcohol have been extensively studied—they include pattern of alcohol consumption, sex, environmental factors (such as diet), and genetic factors, which vary widely among different parts of the world. ALD is becoming more common in many parts of Asia but is decreasing in Western Europe. Treatment approaches, including availability of medications, models of care, and approach to transplantation, differ among regions.

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Section: Treatment Of Audmentioning

confidence: 99%

Alcoholic Liver Disease in Asia, Europe, and North America

2016

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“…The goal of the Program for Effective Mental Health Interventions in Under-Resourced Health Systems (PREMIUM) was to develop and assess scalable psychological treatments that are culturally appropriate, affordable, and feasible for delivery by non-specialist health workers and apply these treatments to the two leading mental health disorders: moderately severe to severe depression (the Healthy Activity Program [HAP]) and harmful drinking (Counselling for Alcohol Problems [CAP]) 13, 14, 15. In this Article, we describe the results of a trial assessing the effectiveness and cost-effectiveness of HAP, 13 a brief psychological treatment adapted from behavioural activation, an empirically supported psychological treatment recommended by WHO 16, 17.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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SummaryBackgroundAlthough 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.MethodsIn 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.FindingsBetween 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 $933...

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“…PREMIUM (Program for Effective Mental Health Interventions in Under-Resourced Health Systems) is a research programme whose goal was to design methods for development and assessment of scalable psychological treatments that are culturally appropriate, affordable, and feasible for delivery by NSHWs and to apply these methods 14 to depression (the Healthy Activity Program [HAP]) 15 and harmful drinking (Counselling for Alcohol Problems [CAP]) 16 . In this Article, we describe the results of a trial assessing the effectiveness and cost-effectiveness of the CAP treatment when used in primary care.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2017

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SummaryBackgroundAlthough 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.MethodsIn 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.FindingsBetween 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·...

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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

Cited by 47 publications

References 34 publications

Alcoholic Liver Disease in Asia, Europe, and North America

Alcoholic Liver Disease in Asia, Europe, and North America

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

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

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