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A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention

University of Manitoba · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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acceptabilitycardiovascular-diseasecardiovascular-diseasescopingfeasibilityheart-diseasephysical-activityself-compassion
The primary aims of this study are to explore the feasibility, acceptability, and safety, of the Compassionate And Loving Mindset towards heart health risk (CALM Hearts) intervention. The CALM Hearts intervention is a self-compassion intervention designed to help women cope with their cardiovascular disease (CVD) risk and adopt health behaviours. Through this research, we expect to identify opportunities to increase the feasibility and acceptability of the intervention. The secondary aims of this study are to observe the directionality of mean changes in behavioural and psychological outcomes from Pre- to Post-Intervention. We predict that all behavioural and psychological outcomes will change in a favourable direction. Participants will be asked to complete three, weekly, intervention sessions in which they will apply self-compassion to coping with their CVD risk and increasing a chosen health behaviour. The intervention will be conducted virtually and led by a trained facilitator. Feasibility will be assessed using pre-established criteria. After completing the intervention participants will be given the option to provide qualitative data on acceptability and safety. Participants will also complete a battery of behaviour and psychological outcome measures at pre-intervention and one-week post-intervention
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