Abstract：
BACKGROUND:Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evidence-based psychological treatment for depression. METHODS:This protocol is for a three-arm, parallel group randomized controlled trial comparing three ways of training NSHWs to deliver the Healthy Activity Program (HAP), a brief manualized psychotherapy for depression, in primary care. The arms are: digital training (DGT); digital training combined with individualized coaching support (DGT+); and conventional face-to-face training (F2F). The target sample comprises N = 336 government contracted NSHWs in Madhya Pradesh, India. The primary outcome is change of competence to deliver HAP; secondary outcomes include cost-effectiveness of the training programs, change in participants' mental health knowledge, attitudes and behavior, and satisfaction with the training. Assessors blind to participant allocation status will collect outcomes pre- (baseline) and post- (endpoint) training to ascertain differences in outcomes between arms. Training program costs will be collected to calculate incremental costs of achieving one additional unit on the competency measure in the digital compared to face-to-face training programs. Health worker motivation, job satisfaction, and burnout will be collected as exploratory outcome variables. DISCUSSION:This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT04157816.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Naslund JA,Tugnawat D,Anand A,Cooper Z,Dimidjian S,Fairburn CG,Hollon SD,Joshi U,Khan A,Lu C,Mitchell LM,Muke S,Nadkarni A,Ramaswamy R,Restivo JL,Shrivastava R,Singh A,Singla DR,Spiegelman D,Bhan A,Patel Vdoi
10.1016/j.cct.2021.106267subject
Has Abstractpub_date
2021-01-06 00:00:00pages
106267eissn
1551-7144issn
1559-2030pii
S1551-7144(21)00003-3journal_volume
102pub_type
杂志文章abstract：BACKGROUND:Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment result...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2013.09.010
更新日期：2013-11-01 00:00:00
abstract：:Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.04.003
更新日期：2017-06-01 00:00:00
abstract：BACKGROUND:Unlike conventional time-to-event analysis of composite endpoints in clinical trials, the "win ratio" method allows for flexibility in prioritizing their components. Here, we compare the EVOLVE trial findings using the win ratio with those from time-to-event analysis. METHODS: EXPOSURE:Randomization to cin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.04.001
更新日期：2016-05-01 00:00:00
abstract：:Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias and invalidate conclusions. Non-responder imputation (NRI), where patients with missing information to determine endpoint status ar...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106226
更新日期：2020-11-22 00:00:00
abstract：BACKGROUND:Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been eval...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2013.08.001
更新日期：2013-11-01 00:00:00
abstract：BACKGROUND:Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these d...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.08.014
更新日期：2016-09-01 00:00:00
abstract：:In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.06.022
更新日期：2019-08-01 00:00:00
abstract：:The convention in clinical trials is to regard outcomes as independently distributed, possibly conditional on covariates, but in some situations they may be correlated. For example, in infectious diseases, correlation may be induced if participants have contact with a common infectious source, or share hygienic tips t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2014.08.001
更新日期：2014-09-01 00:00:00
abstract：BACKGROUND:Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured muc...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106177
更新日期：2020-12-01 00:00:00
abstract：OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.06.002
更新日期：2017-09-01 00:00:00
abstract：:This study was set up to test an ecological intervention using a pragmatic cluster randomised controlled design (RCT) aimed at increasing physical activity (PA) within the community in a deprived inner-city area in the UK. The research will provide a detailed mapping (using Graphical Information Systems GIS) of the en...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2008.03.005
更新日期：2008-09-01 00:00:00
abstract：AIMS:To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial. METHODS:Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.105834
更新日期：2019-10-01 00:00:00
abstract：BACKGROUND:Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.06.014
更新日期：2016-09-01 00:00:00
abstract：BACKGROUND:New approaches are needed to better monitor blood pressure (BP) between physician visits, especially for patients in rural areas or for those who lack transportation. We have developed a custom-built bi-directional texting platform for home BP measurements that can then be managed by clinical pharmacists loc...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106169
更新日期：2020-11-01 00:00:00
abstract：INTRODUCTION:Focal ablation therapy is playing an increasing role in oncology and may reduce the toxicity of current surgical treatments while achieving adequate oncological benefit. Irreversible electroporation (IRE) has been proposed to be tissue-selective with potential advantages compared with current thermal-ablat...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2015.05.002
更新日期：2015-07-01 00:00:00
abstract：BACKGROUND:Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2005.08.002
更新日期：2006-02-01 00:00:00
abstract：UNLABELLED:Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified a...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.07.004
更新日期：2016-07-01 00:00:00
abstract：:We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol...
journal_title：Contemporary clinical trials
pub_type： 更正并重新发布的文章,已发布勘误
doi：10.1016/j.cct.2020.106128
更新日期：2020-10-01 00:00:00
abstract：:Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effect...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2014.06.016
更新日期：2014-09-01 00:00:00
abstract：BACKGROUND:Intake of sugar-sweetened beverages is associated with overweight in observational studies. A possible explanation is that liquid sugars do not satiate and that their intake is not compensated by reduced caloric intake from other foods. However, evidence from intervention studies for this hypothesis is incon...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2011.10.007
更新日期：2012-01-01 00:00:00
abstract：:The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.cct.2007.01.003
更新日期：2007-07-01 00:00:00
abstract：:There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is de...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.02.003
更新日期：2012-05-01 00:00:00
abstract：:Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.08.004
更新日期：2007-05-01 00:00:00
abstract：BACKGROUND:Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI, have lifespans 25-32 years shorter, and thus bear an especially large burden of tobacco-related morbidity and mortality. Several recent studies demonstrate that smokers with SMI can successfully qui...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.06.001
更新日期：2019-08-01 00:00:00
abstract：:Knee osteoarthritis (OA) is a leading cause of late life pain and disability, and non-Hispanic black (NHB) adults experience greater OA-related pain and disability than non-Hispanic whites (NHWs). Recent evidence implicates psychosocial stress, cognitive-attentional processes, and altered central pain processing as co...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106159
更新日期：2020-11-01 00:00:00
abstract：:As a convention, a p-value is often computed in hypothesis testing and compared with the nominal level of 0.05 to determine whether to reject the null hypothesis. Although the smaller the p-value, the more significant the statistical test, it is difficult to perceive the p-value in a probability scale and quantify it ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2015.07.001
更新日期：2015-09-01 00:00:00
abstract：:Depression affects 20-30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV a...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.04.002
更新日期：2012-07-01 00:00:00
abstract：OBJECTIVE:To assess parental decision making and experiences in an autologous umbilical cord blood infusion study in young children with type 1 diabetes (T1D). METHODS:Surveys were completed with 22 parents of children with T1D who received infusion and 22 parents who declined infusion. RESULTS:Parents who stored umb...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2011.04.004
更新日期：2011-07-01 00:00:00
abstract：OBJECTIVE:To describe the study protocol of the Multimedia Self-Management (MSM) intervention to prepare patients and family caregivers (FCGs) for lung cancer surgery. DESIGN:The study is a five-year, single site, randomized controlled trial of 160 lung cancer surgery FCG and patient dyads (320 total participants), co...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.07.002
更新日期：2019-08-01 00:00:00
abstract：BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.03.014
更新日期：2012-07-01 00:00:00
