Evaluating the effectiveness of psychosocial resilience training for heart health, and the added value of promoting physical activity: a cluster randomized trial of the READY program

BACKGROUND Depression and poor social support are significant risk factors for coronary heart disease (CHD), and stress and anxiety can trigger coronary events. People experiencing such psychosocial difficulties are more likely to be physically inactive, which is also an independent risk factor for CHD. Resilience training can target these risk factors, but there is little research evaluating the effectiveness of such programs. This paper describes the design and measures of a study to evaluate a resilience training program (READY) to promote psychosocial well-being for heart health, and the added value of integrating physical activity promotion. METHODS/DESIGN In a cluster randomized trial, 95 participants will be allocated to either a waitlist or one of two intervention conditions. Both intervention conditions will receive a 10 x 2.5 hour group resilience training program (READY) over 13 weeks. The program targets five protective factors identified from empirical evidence and analyzed as mediating variables: positive emotions, cognitive flexibility, social support, life meaning, and active coping. Resilience enhancement strategies reflect the six core Acceptance and Commitment Therapy processes (values, mindfulness, defusion, acceptance, self-as-context, committed action) and Cognitive Behavior Therapy strategies such as relaxation training and social support building skills. Sessions include psychoeducation, discussions, experiential exercises, and home assignments. One intervention condition will include an additional session and ongoing content promoting physical activity. Measurement will occur at baseline, two weeks post intervention, and at eight weeks follow-up, and will include questionnaires, pedometer step logs, and physical and hematological measures. Primary outcome measures will include self-reported indicators of psychosocial well-being and depression. Secondary outcome measures will include self-reported indicators of stress, anxiety and physical activity, and objective indicators of CHD risk (blood glucose, cholesterol [mmol.L-1], triglycerides, blood pressure). Process measures of attendance, engagement and fidelity will also be conducted. Linear analyses will be used to examine group differences in the outcome measures, and the product of coefficients method will be used to examine mediated effects. DISCUSSION If successful, this program will provide an innovative means by which to promote psychosocial well-being for heart health in the general population. The program could also be adapted to promote well-being in other at risk population subgroups. TRIAL REGISTRATION ACTRN12608000017325.