The Mental Health Care Act, 2017 proposes to integrate mental health services even at primary care level in India. This act proposes to provide mental healthcare and services for persons with mental illness so as to protect, promote and fulfill the rights of such persons. Substance use disorders, particularly alcohol dependence, depressive disorders and anxiety disorders are the commonest mental health problems in Indian population (Baxter et al., 2016). This study aim to identify common mental health problems in coal miners. We also propose to examine the effectiveness of a single brief intervention (BI) (education / simple advice)  appropriate for tobacco, alcohol and cannabis as secondary prevention based on patterns of substance use to reduce occupational harm in a sample of coal mine workers in a community based, randomized trial. Brief intervention is cost-effective and can be delivered at primary care setting without specialist support. Participants with alcohol dependence as the main problem shall be provided referral for add-on primary care based pharmacological intervention. The study shall identify patterns of substance use by ASSIST, an eight-question standardized screening tool. At the same time the primary care physicians shall be trained to identify common mental health problems and deliver basic management.

 Screening and brief intervention comprises of ASSIST-based (an eight-question tool) screening for patterns of substance use including tobacco, alcohol and cannabis followed by brief intervention consisting of education, simple advice and brief counseling with an aim to change substance use behavior according to patterns of use typically in a time frame of 3 to 15 min (Humeniuk, 2010b). brief intervention. Subjects with a score of 27 and above for any substance signify dependence and require specialist assessment and treatment along with brief intervention.

Add on pharmacological intervention can be provided with brief intervention for alcohol dependents

 

Objectives:

 Screening for common mental disorders (CMDs) among mine workers.

2.  Screening for patterns of tobacco, alcohol, cannabis use by ASSIST based screening among mine workers at primary care facilities and community based outreach and screening.

3.   Randomize a sample of mine workers screened as “hazardous and harmful” users and investigate effectiveness of brief intervention by comparing outcomes over a 6-month longitudinal design in randomly allocated subject groups receiving “only screening” or “screening and brief intervention”.

 

Subjects & Methodology:

 

Design: The study would be randomized, community based longitudinal, open trial (non-blinded).

 

Study sites: The study would be conducted at Nimcha, Ningha, Satgram, Sodepur and Salanpur of Eastern Coal Field area. Study sites are at an approximate distance of 15 to 20 km from Asansol. This area has an approximate coal mine worker population of 6000; adequate to recruit the required sample for this study.

 

Recruitment: Adult coal mine workers engaged in mining activities (skilled/semi-skilled/unskilled) 18 and above years of age of male sex shall be screened and recruited from the Raniganj – Asansol coal mining areas of Eastern Coalfields Ltd. (workforce size approximately 61,000 in 2013)..

Recruitment of the study participants shall be carried out by systematic random sampling technique. During random screening age of a worker shall be verified from two sources and all workers shall be screened for common mental disorders (CMDs). Following screening for CMDs the following question shall be asked.

1.      Have you consumed alcohol, cannabis in any form (eaten/beverage/smoked) and / or tobacco (smoked/smokeless) in any form during past one year?

2.      Have you consumed alcohol, cannabis in any form (eaten/beverage/smoked) and / or tobacco (smoked/smokeless) in any form during the past 30 days?

Any worker responding “yes” to both questions for any or more than one substance shall be briefed about the study and recruited following completion of informed consent procedure.

 

Sample Size: Common consumption pattern is expected to involve more than one substance, e.g., co-use of alcohol and tobacco. Therefore, assumption for this study is to detect effect of the BI for both pattern of use and specific substance of use. Although the study shall have an intention-to-treat (ITT) approach, we expect an attrition rate of at least 25%.

In the “hazardous and harmful” study group to detect a 20% difference in treatment outcome (10% success in only screening group vs. 30% success in BI group) the study needs to recruit at least n=79 in the only screening group and n=79 in the BI group at a recruitment ratio of 1:1 to improve power with 95% two-sided confidence interval (CI) and 80% power. To account for drop-outs estimated sample size will be n=100 in the only screening group and n=100 in the BI group. Recruitment strategy shall be to enroll n=30 only tobacco users, n=60 alcohol-tobacco co-users; and n=10 only cannabis users in the only screening group and n=30 only tobacco users, n=60 alcohol-tobacco co-users; and n=10 only cannabis users in the BI group.

Our assumption during sample size estimation is based on main substance abuse as the problem. This signifies that we are assuming a priori that all alcohol or other drug users will be having more than one substance abuse problem. For example, participant having alcohol as main problem can also have low level of tobacco / cannabis problem. To address these issues, we have chosen ASSIST based intervention, as it caters to polydrug use. In two arms, numbers of alcohol, tobacco and cannabis users have also been determined from the findings of our pilot study.  

Therefore, the study shall recruit n=200 coal mine workers; considering a 40% prevalence of regular tobacco / alcohol / cannabis use in this population approximately 1000 coal mine workers need to be screened.

 

Screening: On screening all participants will be administered following procedure:

1.      Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Assessment (GAD-7) – For screening of depression and anxiety disorders respectively.

2.      ASSIST (The Alcohol, Smoking and Substance Involvement Screening Test), an eight-question internationally validated tool for screening for “abstinent and low-risk”; “hazardous and harmful” (moderate risk); or “dependent” (high risk) patterns of use, suitably translated.

Patterns of use shall be defined by ASSIST score in the following manner.

“Low-risk” – Score 1 to 3 for tobacco and cannabis; and 1 to 10 for alcohol.

“Hazardous and harmful” – Score 4 to 26 for tobacco and cannabis; and 11 to 26 for alcohol.

“Dependent” – Score 27 and above for all (tobacco, alcohol and cannabis).

 

Allocation: Allocation of intervention shall be as follows.

1.      Participants having found to be common mental disorders will be treated by psychiatrist and based on the ASSIST score, they will be categorized accordingly as follows.

2.      Participants identified as “low-risk” for all substances shall be provided general health advice to remain at “low-risk” level and excluded from the randomized controlled trial.

3.      “Hazardous and harmful” participants shall be randomly allocated from a set of computer generated random numbers to either:

a)      “Only screening” (ASSIST and general health advice) or

b)      “Screening and brief intervention (BI)” group (ASSIST and general health advice with add-on brief intervention).

4.      “Dependent” users with alcohol as the main problem shall receive ASSIST screening; general health advice; brief intervention along with add-on primary care based, supervised, pharmacological management with follow up at 3 and 6 months.

Procedures: Study procedure shall take place in households / local dispensaries during off-duty hours of the participants as well as weekends. All instruments shall be translated to Bengali and Hindi; re-translated; and validated. On screening and recruitment all participants will be administered following procedures:

1.      Socio-demographic instrument – Integrated in modified GENACIS including socio-demographic, economic (e.g., monthly income), family and socio-cultural information.

2.      Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Assessment (GAD-7) – This instrument is simple and easy to use to screen for depression and anxiety disorders in general population respectively.

3.      GENACIS (Gender, Alcohol and Culture: An International Study) modified expanded core questionnaire with Harms to Others (H2O) – Only social networks, drinking variables, familial and other drinking contexts, drinking consequences and violence / victimization domains from GENACIS appropriately modified, translated and validated (Wilsnack, 2009) along with assessment of alcohol related harm experienced in different domains, e.g., children, community. Harms to Others (H2O) shall be administered to the immediate relative of the subject, e.g., spouse; parent for unmarried subject; child for widow/er. The immediate relative shall also complete the informed consent procedure. Genacis will be useful in identifying the effects of gender, culture, with their drinking habits for both women and men. Thus it is having implications in designing more effective prevention & intervention model for policy recommendations.

4.      WHO Health and Work Performance Questionnaire (HPQ) – This instrument measures health, absenteeism and productivity and provides a measure of occupational harm from alcohol abuse; appropriately modified, translated and validated (Kessler, 2003).

5.      SF-36 questionnaire –SF-36, developed by RAND Corporation, USA; is an 11-item standardized instrument for assessment of quality of life in different domains. It is easy to use, acceptable to subjects and fulfills stringent criteria of reliability and validity (Brazier et al., 1992).

6.      Health screening: Physical – All systems physical examination.

 

Intervention: General guidelines for interventions to be used for this study shall be as follows.

1.      General health advice for all participants – It is a 5 minute protocol with an objective to encourage a person to remain at his / her low-risk substance use level.

2.      Brief intervention for “hazardous and harmful” and “dependent” users – A manualized World Health Organization (WHO) guide on brief intervention for use in primary care (Humeniuk, 2010b) shall be adopted, culturally modified, translated and delivered by trained project staff. It is a 5 to 25 minute protocol depending on the number of substances involved and stage of intervention (^1st, ^2nd or ^3rd) based on outcome with multiple components, e.g., feedback on screening results; advice; responsibility; concern; harmful consequences; summary of observations and opportunity to reflect and take-home materials. The control arm who will not receive Brief Intervention (BI) during the randomised controlled trial, will receive same Brief Intervention measures at the end of the trial. Thus principle of ‘justice’ will be maintained throughout the study.

3.      Pharmacological treatment for “dependent” users Standard Control Organization (CDSCO), Government of India and communicated appropriately.  

 

Follow Up: General health advice and brief intervention shall be delivered on recruitment after screening and after three (3) and six (6) months; add on pharmacological management shall be administered according to protocol with follow ups at 3 and 6 months after recruitment; ASSIST, Harms to Others (H2O), HPQ (Work Performance domain only), SF-36, will also be repeated after three (3) and six (6) months for all participants.

Outcome measures will be ASSIST score; health status (physical); absenteeism, injury, sickness, and lost productivity. Costs of productivity due to changes in absenteeism shall be monetized by taking the product of total lost workdays, the participant’s average daily salary, a worker absence multiplier, and a fringe benefits multiplier (Loeppke et al., 2007).

 

Ethics Review:

The proposal has been approved by Institutional Ethics Committee (IEC) of ICMR- Centre for Ageing & Mental Health, Kolkata.

 

Data collection:

Questionnaires will be administered in vernacular languages, i.e. Bengali, and Hindi after taking informed written consent by trained research staff. Interviewer administered data collection will be TAB based. Total time of data collection for each participant shall be between 40 to 45 minutes.

 

Statistical analysis:

The collected data will be entered in Microsoft excel worksheet. Categorical data will be expressed in number and proportions, while continuous data will be checked for normality distribution by Kolmogorov-Smirnov test. Non-significant P value will indicate normal distribution. In case of normal distribution, central tendency and dispersion will be represented by mean and standard deviation; while in presence of skewed distribution or in presence of outlier, median and inter quartile range will be used respectively. Association between two attributes will be calculated by Pearson’s Chi-square test. For normally distributed continuous data, parametric tests like unpaired student’s t test, paired student t test will be performed for comparison between two different and two same groups respectively; while non-parametric - Mann Whitney U test, Wilcoxon Signed rank test will be calculated for skewed distribution accordingly. For comparison of three parameters of the same group either Repeated measure ANOVA (normal distribution) or Friedman’s ANOVA (skewed distribution) will be calculated. Statistical analysis will be performed by SPSS Software (version 21.0). P value equal to or less than 0.05 will be considered as statistically significant.