The Influence of Depression, Positive Health Behaviors, and Weight Status on Glycated Hemoglobin: A Sequential Mediation Analysis of the INDEPENDENT Trial.

Background: Collaborative care models (CoCM) improve both depression and cardiometabolic outcomes, but the mechanisms driving these effects remain unclear.

Objective: To determine whether changes in depressive symptoms, positive health behaviors (PHBs), body mass index (BMI), and waist circumference mediate the effect of an adapted CoCM on glycemic control among adults with cardiometabolic risk in India.

Design: Longitudinal structural equation modeling of data from the INtegrating DEPrEssioN and Diabetes TreatmENT (INDEPENDENT) Randomized Control Trial.

Profile of monogenic diabetes: a Pan-India study.

Aim: To evaluate the frequency of monogenic diabetes mutations among individuals clinically suspected to have monogenic diabetes in India.

Methods: Participants (n = 774) were recruited from 65 diabetes centres across India (http://monogenicdiabetes.in/Collaborators.

The Impact of Yoga Intervention on Physical and Mental Health of Adults with Type 2 Diabetes.

Aim: To assess the impact of a yoga intervention on the physical and mental health of adults with type 2 diabetes.

Methods: This study was conducted at Madras Diabetes Research Foundation, Chennai, for 6 months. Participants aged 18-65 years, diagnosed with type 2 diabetes mellitus (T2DM), and glycated hemoglobin (HbA1c) levels ranging from ≥7.

A mediation analysis evaluating change in self-stigma on diabetes outcomes among people with depression in urban India: A secondary analysis from the INDEPENDENT trial of the collaborative care model.

Self-stigma-the internalization of negative community attitudes and beliefs about a disease or condition-represents an important barrier to improving patient care outcomes for people living with common mental disorders and diabetes. Integrated behavioral healthcare interventions are recognized as evidence-based approaches to improve access to behavioral healthcare and for improving patient outcomes, including for those with comorbid diabetes, yet their impact on addressing self-stigma remains unclear. Using secondary data from the Integrating Depression and Diabetes Treatment (INDEPENDENT) study-a trial that aimed to improve diabetes outcomes for people with undertreated and comorbid depression in four urban Indian cities via the Collaborative Care Model-we longitudinally analyzed self-stigma scores and evaluated whether change in total self-stigma scores on diabetes outcomes is mediated by depressive symptom severity.

Factors influencing diabetes treatment satisfaction in the INtegrating DEPrEssioN and Diabetes treatmENT randomized clinical trial: A multilevel model analysis.

Aims: Patient satisfaction is associated with positive diabetes outcomes. However, there are no identified studies that evaluate both patient- and clinic-level predictors influencing diabetes care satisfaction longitudinally.

Methods: Data from the INtegrating DEPrEssioN and Diabetes treatmENT trial was used to perform the analysis.

Association of collaborative care intervention features with depression and metabolic outcomes in the INDEPENDENT study: A mixed methods study.

Aims: The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) trial tested a collaborative care model including electronic clinical decision support (CDS) for treating diabetes and depression in India. We aimed to assess which features of this clinically and cost-effective intervention were associated with improvements in diabetes and depression measures.

Methods: Post-hoc analysis of the INDEPENDENT trial data (189 intervention participants) was conducted to determine each intervention feature's effect: 1.

The Impact of a Collaborative Care Model on Health Trajectories among Patients with Co-Morbid Depression and Diabetes: The INDEPENDENT Study.

Context: Collaborative care models for depression have been successful in a variety of settings, but their success may differ by patient engagement. We conducted a post-hoc analysis of the INDEPENDENT trial to investigate the role of differential engagement of participants on health outcomes over 3 years.

Settings And Design: INDEPENDENT study was a parallel, single-blinded, randomised clinical trial conducted at four socio-economically diverse clinics in India.

Reliability and Validity of the Adolescence Stress Scale (ADOSS) for Indian Adolescents.

Background: Stress levels increase tremendously in adolescence. Indian adolescents derive much of their stress from school and family pressures. Developing a standardized tool to assess adolescent stress can help early diagnosis.

Strategies for participant retention in long term clinical trials: A participant -centric approaches.

A clinical trial is the most foolproof method to evaluate the efficacy of a new intervention. Successful completion of clinical trials depends on the retention of the participants enrolled. Poor participant retention can lead to significant time and cost burden and have potentially adverse biases on the results.

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention.

Background: Collaborative care (CC) is a multicomponent team-based approach to providing mental health care with systematic integration into outpatient medical settings. The 12-month INDEPENDENT CC intervention improved joint disease control measures in patients with both depression and diabetes at 12 and 24 months following randomization.

Objective: This study investigated the durability of intervention effects on patient outcomes at 36 months following randomization.

A realist process evaluation of the INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) randomized controlled trial in India.

Aims: We aimed to determine what key resources, mechanisms, and contextual factors are necessary to integrate depression and diabetes treatment into low-resource settings.

Methods: A realist evaluation framework was employed to conduct a comparative case study. Data were collected through document review, key informant interviews ( = 4), activity logs, and interviews with implementing health care providers (n = 11) to test and refine program theories for collaborative care.

Cost-Effectiveness of a Collaborative Care Model Among Patients With Type 2 Diabetes and Depression in India.

Objective: To assess the cost-effectiveness of collaborative versus usual care in adults with poorly controlled type 2 diabetes and depression in India.

Research Design And Methods: We performed a within-trial cost-effectiveness analysis of a 24-month parallel, open-label, pragmatic randomized clinical trial at four urban clinics in India from multipayer and societal perspectives. The trial randomly assigned 404 patients with poorly controlled type 2 diabetes (HbA1c ≥8.

Effect of a collaborative care model on anxiety symptoms among patients with depression and diabetes in India: The INDEPENDENT randomized clinical trial.

Objective: We assessed the impact of a collaborative care intervention on anxiety symptoms among participants in India with comorbid depression, poorly controlled diabetes, and moderate to severe anxiety symptoms.

Method: We analyzed data from a randomized controlled trial conducted at four diabetes clinics in India. Participants received either collaborative care or usual care.

Comparison of Glycemic Excursion Using Flash Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose.

To determine the effect of Voglibose add-on therapy on daily glycemic excursions (using FreeStyle Libre Pro™, a Flash glucose monitoring system) in Indian patients with type 2 diabetes mellitus (T2DM) receiving a stable dose of metformin (Met) or metformin+sulfonylurea (Met+SU). T2DM patients with glycosylated hemoglobin (HbA1c) ≥7.0% and at least two postprandial excursions ≥140 mg/dL (within 2 h of meal) during the screening phase (visit 1/day -14 ± 2) were enrolled in this prospective, multicenter interventional study.

Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial.

Importance: Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.

Objective: To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.

Design, Setting, And Participants: Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL.

Acceptability and Utilization of Newer Technologies and Effects on Glycemic Control in Type 2 Diabetes: Lessons Learned from Lockdown.

To evaluate the effects of a prolonged lockdown due to Coronavirus (COVID-19) on the adoption of newer technologies and changes in glycemic control on patients with type 2 diabetes (T2D) in India. The study population included a random list of 3000 individuals with T2D derived from 30,748 individuals who had visited a large tertiary diabetes center during the past year. The survey was carried out through a telephonic interview.

Estimation of the prevalence of depression using diagnostic instruments in the elderly population in India, 2000-2019: a systematic review protocol.

Introduction: Depression is a common mental disorder in the elderly population, which significantly impacts their quality of life. However, correct estimates of its magnitude are not available in the elderly in India. The present systematic review and meta-analysis would attempt to estimate the prevalence of depression using diagnostic instruments among elderly persons aged 60 years and above.

Altered circulatory levels of miR-128, BDNF, cortisol and shortened telomeres in patients with type 2 diabetes and depression.

Aims: Several studies have reported the role of biomarkers either in diabetes or depression. The present study is aimed at profiling the circulating levels of miR-128, brain-derived neurotrophic factor (BDNF), cortisol and telomere length in patients with type 2 diabetes with and without depression compared to individuals with normal glucose tolerance.

Methods: Study subjects (n = 160) were recruited from an ongoing epidemiological study in southern India.

Adaptations and patient responses to behavioral intervention components in a depression-focused chronic disease care model implemented in India.

Integrated care models offer one approach to treat patients with chronic multimorbidity. However, because these models consist of multiple components designed to provide individualized care, they should be adapted to best meet the needs of patients in diverse settings. This paper presents qualitative and quantitative data from a realist process evaluation embedded in the INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study to uncover what worked, for whom, how, and in what circumstances.

Epidemiology of Depression and its Relationship to Diabetes in India.

Depression is one of the most common chronic mental illnesses globally and in India. It has been reported that depression is twice as common in individuals with type 2 diabetes. The prevalence of both depression and type 2 diabetes are rapidly increasing.

Input of stakeholders on reducing depressive symptoms and improving diabetes outcomes in India: Formative work for the INDEPENDENT Study.

Aims: Depression and diabetes are highly comorbid, adversely affecting treatment adherence and resulting in poor outcomes. To improve treatment and outcomes for people dually-affected by diabetes and depression in India, we aimed to develop and test an integrated care model. In the formative phase of this INtegrated DEPrEssioN and Diabetes TreatmENT (INDEPENDENT) study, we sought stakeholder perspectives to inform culturally-sensitive adaptations of the intervention.

Association of depression with common carotid artery intima media thickness and augmentation index in a large Urban South Indian population- The Chennai Urban Rural Epidemiology Study (CURES - 138).

Aim: The aim of the study was to assess the relationship of depression with carotid intima media thickness and augmentation index in Asian Indians.

Research Design And Methods: For this study, 1505 subjects were randomly selected from a population based study conducted in Chennai, South India. Right common carotid artery intima medial thickness [IMT] was determined using high-resolution B-mode ultrasonography.

Why are clinical trials necessary in India?

Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants.

Effect of spironolactone and amiloride on thiazolidinedione-induced fluid retention in South Indian patients with type 2 diabetes.

Background And Objectives: Thiazolidinediones (pioglitazone and rosiglitazone) induce renal epithelial sodium channel (ENaC)-mediated sodium reabsorption, resulting in plasma volume (PV) expansion. Incidence and long-term management of fluid retention induced by thiazolidinediones remain unclear.

Design, Setting, Participants, & Measurements: In a 4-week run-in period, rosiglitazone, 4 mg twice daily, was added to a background anti-diabetic therapy in 260 South Indian patients with type 2 diabetes mellitus.