scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Lay Health Worker ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. There are 56Primary Health Centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each, and the intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire, (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire, (GAD-7) and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model are employed for binary outcomes and linear mixed effects models for continuous outcomes. A Return on investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project. Discussion: Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of implementation of a psychosocial mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Lay Health Worker ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. 56 PHCs in Mehsana district are equally divided into four clusters of 14 PHCs each, and the intervention is rolled out in cluster in a staggered manner at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-reporting questionnaire-20 (SRQ-20), functioning using the WHO Disability Assessment Scale (WHO-DAS-12), depression symptoms (Patient Health Questionnaire, PHQ-9)) and anxiety symptoms (Generalized Anxiety Disorder Questionnaire, GAD-7) and social participation using the Social Participation Scale (SPS). Linear mixed effects models are employed for continuous outcomes and generalized linear mixed effects model for binary outcomes. Discussion Stepped wedge designs are progressively being used to evaluate real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a LMIC evaluating the impact of the implementation of a mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in LMICs.

scholarly journals Atmiyata, a community led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Mixed Effects ◽  
Stepped Wedge ◽  
Linear Mixed Effects ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide evidence-based counselling for persons with common mental disorders (CMD) as part of a package of community-based interventions for mental health. Methods: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial spans across 10 sub-blocks (645 villages) in Mehsana district with 1.52 million rural adult population. There are 56 primary health centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each, and the intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the World Health Organization’s Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire, (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire, (GAD-7) and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model are employed for binary outcomes and linear mixed effects models for continuous outcomes. A Return on Investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project.

scholarly journals Atmiyata, a community-led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India

2019 ◽  
Author(s):  
Kaustubh Joag ◽  
Jasmine Kalha ◽  
Deepa Pandit ◽  
Susmita Chatterjee ◽  
Sadhvi Krishnamoorthy ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Stepped Wedge ◽  
Middle Income ◽  
Linear Mixed Effects ◽  
Middle Income Countries ◽  
Cluster Randomized ◽  
The Impact ◽  
Low And Middle Income

Abstract Background: While lay-health worker models for mental health care have proven to be effective in controlled trials, there is limited evidence on the effectiveness and scalability of these models in rural communities in low- and middle-income countries (LMICs). Atmiyata is a rural community-led intervention using local community volunteers, called Champions, to identify and provide a package of community-based interventions for mental health, including evidence-based counseling for persons with common mental disorders (CMD). Methods: The impact of the Atmiyata intervention is evaluated through a stepped wedge cluster randomized controlled trial (SW-CRCT) with a nested economic evaluation. The trial is implemented across 10 sub-blocks (645 villages) in Mehsana district in the state of Gujarat, with a catchment area of 1.52 million rural adults. There are 56 primary health centers (PHCs) in Mehsana district and villages covered under these PHCs are equally divided into four groups of clusters of 14 PHCs each. The intervention is rolled out in a staggered manner in these groups of villages at an interval of 5 months. The primary outcome is symptomatic improvement measured through the GHQ-12 at a 3-month follow-up. Secondary outcomes include: quality of life using the EURO-QoL (EQ- 5D), symptom improvement measured by the Self-Reporting Questionnaire-20 (SRQ-20), functioning using the World Health Organization’s Disability Assessment Scale (WHO-DAS-12), depression symptoms using the Patient Health Questionnaire (PHQ-9), anxiety symptoms using Generalized Anxiety Disorder Questionnaire (GAD-7), and social participation using the Social Participation Scale (SPS). Generalized linear mixed effects model is employed for binary outcomes and linear mixed effects model for continuous outcomes. A Return on Investment (ROI) analysis of the intervention will be conducted to understand whether the intervention generates any return on financial investments made into the project. Discussion: Stepped wedge designs are increasingly used a design to evaluate the real-life effectiveness of interventions. To the best of our knowledge, this is the first SW-CRCT in a low- and middle-income country evaluating the impact of the implementation of a community mental health intervention. The results of this study will contribute to the evidence on scaling-up lay health worker models for mental health interventions and contribute to the SW-CRCT literature in low- and middle-income countries.

scholarly journals The Effect of Providing Free Eyeglasses on Children’s Mental Health Outcomes in China: A Cluster-Randomized Controlled Trial

2018 ◽  
Vol 15 (12) ◽  
pp. 2749 ◽  
Author(s):  
Hongyu Guan ◽  
Huan Wang ◽  
Kang Du ◽  
Jin Zhao ◽  
Matthew Boswell ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Rural China ◽  
Controlled Trial ◽  
Poor Mental Health ◽  
School Students ◽  
Randomized Controlled ◽  
Learning Anxiety ◽  
Cluster Randomized ◽  
The Impact

If children with common vision problems receive and use eyeglasses, their educational performance rises. Without proper treatment, visually impaired children may not achieve educational gains and could suffer from poor mental health. We use a randomized controlled trial to study the impact of an eyeglasses promotion program in rural China on the mental health of myopic primary school students. Three measures of mental health are used: learning anxiety, physical anxiety, and scores on the Mental Health Test (MHT). Our empirical analysis showed that on average, the treatment has small and insignificant for learning anxiety and MHT, and a small but significant reduction in physical anxiety. However, subgroup analysis reveals that myopic students who study more intensively see their learning anxiety and physical anxiety reduced after being provided with eyeglasses. In contrast, students with the lower study intensity suffer a rise in learning anxiety after receiving eyeglasses. A potential mechanism for the differing impacts is the increase in teasing reported among low study-intensity students that does not occur for high study-intensity students. Care should be taken to maximize the benefits and minimize the costs of in-school vision programs.

scholarly journals The Impact of Normal Saline or Balanced Crystalloid on Plasma Chloride Concentration and Acute Kidney Injury in Patients With Predicted Severe Acute Pancreatitis: Protocol of a Phase II, Multicenter, Stepped-Wedge, Cluster-Randomized, Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Bo Ye ◽  
Mingfeng Huang ◽  
Tao Chen ◽  
Gordon Doig ◽  
Bin Wu ◽  
...  
Keyword(s):  
Normal Saline ◽  
Controlled Trial ◽  
Chloride Concentration ◽  
Kidney Injury ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Plasma Chloride ◽  
Cluster Randomized ◽  
The Impact ◽  
Balanced Crystalloids

Introduction/aim: The supraphysiologic chloride concentration of normal saline may contribute to acute kidney injury (AKI). Balanced crystalloids can decrease chloride concentration and AKI in critically ill patients. We aim to test the hypothesis that, in patients with predicted severe acute pancreatitis (pSAP), compared with saline, fluid therapy with balanced crystalloids will decrease plasma chloride concentration.Methods/Design: This is a multicenter, stepped-wedge, cluster-randomized, controlled trial. All eligible patients presenting to the 11 participating sites across China during the study period will be recruited. All sites will use saline for the first month and sequentially change to balanced crystalloids at the pre-determined and randomly allocated time point. The primary endpoint is the plasma chloride concentration on day 3 of enrollment. Secondary endpoints will include major adverse kidney events on hospital discharge or day 30 (MAKE 30) and free and alive days to day 30 for intensive care admission, invasive ventilation, vasopressors, and renal replacement therapy. Additional endpoints include daily serum chloride and sequential organ failure assessment (SOFA) score over the first seven days of enrollment.Discussion: This study will provide data to define the impact of normal saline vs. balanced crystalloids on plasma chloride concentration and clinical outcomes in pSAP patients. It will also provide the necessary data to power future large-scale randomized trials relating to fluid therapy.Ethics and Dissemination: This study was approved by the ethics committee of Jinling Hospital, Nanjing University (2020NZKY-015-01) and all the participating sites. The results of this trial will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration: The trial has been registered at the Chinese Clinical Trials Registry (ChiCTR2100044432).

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