Abstract
BackgroundPeople 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.MethodsA 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.DiscussionThe 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 registrationChinese Clinical Trial Registry - ChiCTR-IPR-17012606, registered on 07 September 2017.
Highlights
Introduction of meditationAudio Autogenic training with imagery and self-suggestions Anger managementAudio Mantra meditationSocial support and review of the programAudio Imagery and meditationReview and course evaluation of all sessions based on the time slots they selected
Existing mobile-based health (mHealth) studies were mostly pre-post designs without a control group or had small sample sizes; there is a lack of mHealth interventions with a rigorous design of randomized controlled trial (RCT) [17]. To address this literature gap, we developed the mHealth intervention “Run4Love” based on our pilot study and relevant literature
The Run4Love study achieved the targeted enrollment of 300 People living with HIV (PLWH) with elevated depressive symptoms
Summary
Overall study design This intervention was designed for PLWH with elevated depressive symptoms. Eligible patients who provided informed consent were enrolled and, after a baseline interview and hair sample collection, randomized to the Run4Love intervention group or the waitlist control group. Intervention protocol Participants in the intervention group received a 3-month mHealth intervention of the Run4Love, consisting of the following two major components: the adapted cognitive-behavioral stress management (CBSM) course and regular physical activity promotions delivered by our enhanced WeChat platform. One week after the recruitment, we called the participants to confirm their enrollment and assisted them to set goals for weekly physical activities (e.g., walk 8000 steps a day) They learned to adjust their exercise routine based on personalized feedback sent via WeChat. Automatic progress monitoring Participants receive CBSM and physical activity promotion information (including audio, pictures, and short essays) on their WeChat account 3–4 times a week. Audio Breathing, imagery, passive progressive muscle relaxation for 4 muscle groups
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