1.
Run4Love, a mHealth (WeChat-based) intervention to improve mental health of people living with HIV: a randomized controlled trial protocol.
Guo, Y, Hong, YA, Qiao, J, Xu, Z, Zhang, H, Zeng, C, Cai, W, Li, L, Liu, C, Li, Y, et al
BMC public health. 2018;(1):793
Abstract
BACKGROUND People living with HIV (PLWH) suffer from high rates of mental illness; but targeted effective interventions are limited, especially in developing countries. High penetration of smartphone usage and widespread acceptance of social media applications provide an unprecedented opportunity for mobile-based health interventions (mHealth interventions) in resource-limited settings like China. The current report describes the design and sample characteristics of the Run4Love randomized controlled trial (RCT) aimed at improving mental health in PLWH in China. METHODS A total of 300 PLWH with elevated depressive symptoms were recruited and randomized into either the intervention or control group. Participants in the intervention group received an adapted cognitive-behavioral stress management (CBSM) course delivered by the enhanced WeChat platform (for 3 months) and were motivated to engage in physical activities. Progress of the participants was automatically tracked and monitored with timely feedback and rewards. The control group received a brochure on nutrition for PLWH in addition to standard care. The outcome assessments are conducted at baseline, 3, 6, and 9 months using tablets. The primary outcome is depressive symptoms measured by the scale of the Center for Epidemiology Studies Depression (CES-D). Secondary outcomes include quality of life, chronic stress measured with biomarker of hair cortisol, and other measures of stress and depression, self-efficacy, coping, HIV-related stigma, physical activity, and patient satisfaction. Mixed effects model with repeated measures (MMRM) will be used to analyze the intervention effects. DISCUSSION The Run4Love study is among the first efforts to develop and evaluate a multicomponent and integrated mHealth intervention to improve the mental health and quality of life of PLWH. Once proven effective, Run4Love could be scaled up and potentially integrated into the routine case management of PLWH and adapted to other populations with chronic diseases. TRIAL REGISTRATION Chinese Clinical Trial Registry - ChiCTR-IPR-17012606 , registered on 07 September 2017.
2.
The wellness incentives and navigation project: design and methods.
Shenkman, E, Muller, K, Vogel, B, Nixon, SJ, Wagenaar, AC, Case, K, Guo, Y, Wegman, M, Aric, J, Stoner, D
BMC health services research. 2015;:579
Abstract
BACKGROUND About 35 % of non-elderly U.S. adult Medicaid enrollees have a behavioral health condition, such as anxiety, mood disorders, substance use disorders, and/or serious mental illness. Individuals with serious mental illness, in particular, have mortality rates that are 2 to 3 times higher as the general population, which are due to multiple factors including inactivity, poor nutrition, and tobacco use. 61 % of Medicaid beneficiaries with behavioral health conditions also have multiple other co-occurring chronic physical health conditions, which further contributes to morbidity and mortality. The Wellness Incentives and Navigation (WIN) project is one of 10 projects under the Centers for Medicare and Medicaid Services "Medicaid Incentives for the Prevention of Chronic Diseases" Initiative, to "test the effectiveness of providing incentives directly to Medicaid beneficiaries of all ages who participate in prevention programs, and change their health risks and outcomes by adopting healthy behaviors." METHODS/DESIGN WIN is a three-year randomized pragmatic clinical trial designed to examine the comparative effectiveness of the combined use of personal navigators, motivational interviewing, and a flexible wellness account on cardiovascular risk reduction among individuals in Medicaid with co-occurring physical and mental health conditions or serious mental illness alone relative to the usual care provided within Medicaid Managed Care. 1250 individuals, identified through Medicaid claims data, were recruited and randomly assigned to an intervention group or control group with outcomes tracked annually. A comparison group was also recruited to help assess the study's internal validity. DISCUSSION The primary outcomes are physical and mental health related quality-of-life as measured by the SF-12, and BMI, blood pressure, LDL-C, and Hba1c results for those who are diabetic measured clinically. The purpose of this paper is to present the unique design of the WIN trial prior to results becoming available in hopes of assisting other researchers in conducting community-based randomized pragmatic trials. Outcomes will be assessed through the linkage of patient reported outcomes, health care claims, and electronic health record data. TRIAL REGISTRATION NCT02440906.