Brief intervention for hazardous drinking delivered using text messaging: a pilot randomised controlled trial from Goa, India.

OBJECTIVE: To evaluate the feasibility and acceptability of a mobile-based brief intervention (BI), generate preliminary estimates of the impact of the BI and fine-tune the procedures for a definitive randomised controlled trial. DESIGN: Parallel three-arm single-blind individually randomised controlled pilot trial. Eligible and consenting participants were randomised to receive mobile-based BI, face-to-face BI and information leaflet. SETTING: Educational institutions, workplaces and primary care centres. PARTICIPANTS: Adult hazardous drinkers. RESULTS: Seventy-four participants were randomised into the three trial arms; forty-eight (64·9 %) completed outcome evaluation. There were no significant differences between the three arms on change in any of the drinking outcomes. There were however in two-way comparisons. Face-to-face BI and mobile BI were superior to active control for percent days heavy drinking at follow-up, and mobile BI was superior to active control for mean grams ethanol consumed per week at follow-up. CONCLUSION: The encouraging findings about feasibility and preliminary impact warrant a definitive trial of our intervention and if found to be effective, our intervention could be a potentially scalable first-line response to hazardous drinking in low-resource settings

Home-detoxification and relapse prevention for alcohol dependence in low resource settings: An exploratory study from Goa, India.

Despite the increasing burden of alcohol dependence, treatment resources in low- and middle-income countries such as India are concentrated in poorly accessible tertiary care facilities. The aim of our study was to examine the feasibility and acceptability of lay health worker-delivered home-based packages of care for alcohol dependence. We conducted an uncontrolled treatment cohort with alcohol-dependent adult males recruited in primary and secondary care. Lay health workers delivered home-detoxification and/or relapse prevention counseling. Process data were analyzed using descriptive statistics. Eleven men with alcohol dependence received home detoxification and relapse prevention counseling, and 27 men received only relapse prevention counseling. Of the 11 receiving home detoxification, one participant re-started drinking; all the rest safely completed the home detoxification. During detoxification, the pulse, blood pressure, and temperature remained within the normal range and ataxia, dehydration, disorientation, and sleep normalized over the course of the detoxification. Of the 38 who entered relapse prevention treatment, 15 (39.5%) completed treatment or had a planned discharge. The mean number of sessions was 2.4 (SD = 1.3); those who had a planned discharge received an average of 3.7 (SD 0.5) sessions, and those who dropped out received an average of 1.4 (SD 0.8) sessions. There was no significant change in daily alcohol consumption and percentage days of heavy drinking (PDHD) between baseline and follow-up in the whole cohort. The SIP score reduced significantly in the whole cohort (24.5 vs. 15.0, p = 0.002), and also reduced when segregated by treatment settings, and type of treatment package received. With appropriate adaptations, our intervention warrants further research, as it has the potential to bridge the significant treatment gap for alcohol dependence in low- and middle-income countries

Video-augmentation of the informed consent process in mental health research: An exploratory study from India.

Only around 50–75% of individuals fully understand the various aspects of informed consent in research. The aim of our study was to examine whether supplementing the conventional paper-based informed consent process with an audiovisual aid improves participants’ understanding of the informed consent process and the information conveyed to them. Participants from two mental health/substance use intervention development studies were recruited for this study through consecutive sampling. They were then administered the traditional paper information and consenting process by itself or in combination with a video depicting the procedures of the study. Subsequently a bespoke questionnaire was administered to assess the participants’ understanding of the information conveyed to them about the parent study. The various domains of the questionnaire were compared between those who were administered the two different consenting processes using the chi square test. 27 (58.7%) participants were administered the traditional consenting process and 19 were administered the video-supplemented consenting process. The video-supplemented consenting process was not superior to the traditional paper-based informed consent process on any of the domains examined. In settings with participants having a limited education, and in research involving people with mental health or substance use problems, further research is necessary to identify contextually relevant best practices for the informed consent process

The systematic development of a mobile phone–delivered brief intervention for hazardous drinking in India

Background: The treatment gap for alcohol use disorders (AUD) in India is the highest among all mental health and substance use disorders. Despite evidence of the cost effectiveness of brief interventions (BIs) for hazardous drinking, implementation in low- and middle-income countries (LMICs) is rare due to several human resource–related barriers. This paper describes the processes and outputs of a study aimed at systematically developing a mobile phone–delivered BI to overcome such barriers. Methods: This is a mixed methods study with four steps: (1) Review of existing relevant evidence base by extracting data from studies cited in two recent, relevant and high-quality systematic reviews; (2) In-depth interviews (IDIs) with 11 national experts in addictions research and practice, and 22 hazardous drinkers; (3) Delphi survey (2 rounds) to identify components for the intervention package through consensus building; and (4) Content and intervention development workshops with a range of stakeholders to develop the intervention package. Results: The research team sourced 72 journal articles from two selected systematic reviews. Key content areas extracted from the studies included facts and statistics about health related to drinking behavior, self-reflection, goal-setting messages, motivational messages, and skills to manage risky situations. The IDIs with experts and hazardous drinkers endorsed most of these content areas as well. The Delphi survey achieved consensus on 19 content areas, which included targeted recommendations, personalized feedback and information, goal management, and coping skills. The content and intervention development workshops resulted in an intervention package delivered over 8 weeks, with the following seven themes guiding the content of the weekly messages: safe drinking/health education, alcohol reduction, drinking and risk management, drinking alternatives, situational content, urge management, and maintenance and relapse prevention. Conclusion: The research team designed this study to consider contextual factors while developing the intervention, which is important to ensure acceptability and feasibility of the intervention. Interestingly, the contextually informed intervention components had several commonalities with BIs developed and tested in high-income countries.</p

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

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