Compassionate and loving mindset towards heart health risk (calm hearts): A non-randomized pilot feasibility study for a parallel randomized controlled trial

2021 
Self-compassion may help people manage reactions and motivate behaviour change in response to health-risk information. We examined the feasibility and acceptability of a self-compassion intervention for women at-risk of cardiovascular disease and, secondarily, mean trends. Women aged 55-75 years at intermediate-to-high Framingham Disease risk, scoring below the mean in self-compassion, were recruited from the WARM Hearts cohort (ClinicalTrials.gov:NCT03938155). Participants completed three weekly virtual sessions. Session I (90-minutes): participants received cardiovascular risk information, were introduced to self-compassion, and self-selected a behaviour-change goal (e.g., physical activity). Sessions II and III (60-minutes): participants applied self-compassion to cardiovascular risk and behaviour-change. Home practice was assigned after Sessions I and II. Feasibility outcomes were recruitment, retention, adherence, resources, facilitator fidelity, acceptability, and safety. Pre- and post-intervention questionnaires assessed self-compassion, health behaviours, health intentions, and affective reactions. Questionnaires were examined for comprehension and proper utilization. Means were observed for trends. Of 103 potential participants, 11(11%) met the two inclusion criteria. Recruitment, retention, and attendance was 100%. Some sessions (39%) exceeded the allotted time (Session I Mmin.=83.4, SD=11.7; Session II Mmin.=68.6, SD=8.9; Session III Mmin.=54.7, SD=9.7). All topics were discussed in 97% of sessions, facilitator fidelity was 98%, and home-practice completion was 71%. Facilitator/participant feedback demonstrated acceptability and safety. Questionnaires were comprehended and utilized properly. Mean changes for self-compassion, health behaviours, and affective reactions were in the expected direction. The intervention appears feasible and acceptable. In a future two-arm trial, session content may be adjusted to facilitate timely completion, and participants further prompted to complete home practice.
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