An interventional study of Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention in Self-Compassion, Physical Inactivity and Cardiovascular Diseases, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to female participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by University of Manitoba · Not applicable, Interventional, and Prevention
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
Participants will be recruited via phone and email and complete an online written consent form
After consenting, participants will complete baseline measures housed on SurveyMonkey (https://www.surveymonkey.com) and will receive a fillable online workbook to complete throughout the intervention. The CALM Hearts intervention will be conducted individually (i.e., one facilitator meeting with one participant) over the phone or via Zoom videoconferencing once per week for three weeks. The intervention facilitator will be a research assistant with training in self-compassion and health psychology.
At pre-intervention, participants will complete behavioural and psychological measures (baseline survey).
In Session 1 (90 minutes), the facilitator will present report cards outlining each participant's CVD risk factors as determined by their participation in a previous study. Immediately after receiving their risk information, participants will complete an online questionnaire assessing their reactions to the CVD risk report (Session 1 measures). The facilitator will then introduce self-compassion as a tool for coping with CVD risk and adopting health behaviours. Finally, the facilitator will work with participants to set a health behaviour goal for the end of the intervention that follows the SMART goals framework (i.e., Specific, Measurable, Attainable, Realistic, and Time-bound). After Session 1, participants will receive a physical copy of their CVD risk report card in the mail.
Sessions 2 (60 minutes) and 3 (60 minutes) will apply self-compassion to participants' health behaviours and CVD risk. These sessions will include a lesson on self-compassion, a workbook activity, and a discussion with the facilitator.
After Sessions 1 and 2, participants will independently complete self-compassionate writing activities in their workbooks. We will ask participants to report the percentage of workbook activities they finish each week (0 to 100%).
One week after Session 3, participants will complete the post-intervention questionnaire and will be debriefed.
Participants will be invited to provide feedback about their experiences in the intervention via an open-ended online survey or telephone interview after the intervention concludes. These responses will contribute to assessing intervention acceptability.
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Exclusion Criteria:
The CALM Hearts intervention will be conducted individually (i.e., one facilitator meeting with one participant) over the phone or via Zoom videoconferencing once per week for three weeks. Session 1 (90 minutes): Participants will learn about their CVD risk factors. The facilitator will introduce self-compassion as a tool for coping with CVD risk and adopting health behaviours. Participants will set a health behaviour goal to accomplish by intervention end. Sessions 2 (60 minutes) and 3 (60 minutes each): Lesson, workbook activity, and discussion on applying self-compassion to health behaviours and CVD risk. Participants will independently complete self-compassionate writing activities in their workbooks after Sessions 1 and 2.
Behavioral: Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention
Self-compassion and health behaviour change intervention for women at risk for cardiovascular disease
Also known as: CALM Hearts
Feasibility Domain 1: Recruitment
Recruitment will be assessed using the following criteria: * Percentage of WARM Hearts participants who are eligible. Criterion = Observe and report * Percentage of eligible participants who agree to participate. Criterion = Observe and report * Average time for enrollment, baseline questionnaire and scheduling. Criterion = 2 weeks * Most successful recruitment strategy. Criterion = Observe and report
Time frame: Assessed from baseline to 1-week post-intervention
Feasibility Domain 2: Retention and Adherence
Retention and adherence will be assessed using the following criteria: * Participant retention rate. Criterion = 80-85% at post-intervention * Demographics of withdrawn participants. Criterion = Observe and report * Reasons for withdrawal. Criterion = Observe and report * Session attendance. Criterion = 90%-95% attendance * Rates of questionnaire completion. Criterion = 80% overall completion * Home practice compliance. Criterion = 75% compliance
Time frame: Assessed from baseline to 1-week post-intervention
Feasibility Domain 3: Fidelity
Fidelity will be assessed using the following criteria: * Completion of all slides in sessions. Criterion = 90%-95% slide completion * Completion of topics in sessions. Criterion = 90%-95% topic completion * Completion of sessions within the allotted time. Criterion = 90%-95% timely completion * Quality of intervention delivery. Criterion = \>80% fidelity as scored by the senior researcher * Technical difficulties with intervention delivery. Criterion = Observe and report
Time frame: Assessed from baseline to 1-week post-intervention
Feasibility Domain 4: Capacity
Capacity will be assessed using the following criteria: - Time required to deliver all aspects of the intervention. Criterion = Observe and report
Time frame: Assessed from baseline to 1-week post-intervention
Acceptability of the CALM Hearts Intervention
Acceptability will be assessed using post-intervention interviews and open-ended surveys administered to participants. Suggestions for increasing acceptability will be noted.
Time frame: Assessed at 1-week post-intervention
Safety of the CALM Hearts Intervention
Safety will be assessed using post-intervention interviews and open-ended surveys administered to participants. The criterion for safety = 100% safe.
Time frame: Assessed at 1-week post-intervention
Self-Compassion
Self-Compassion Scale (Neff, 2003): Participants responded to 26 questions about their tendency to treat themselves with self-compassion or self-criticism using a five-point Likert scale (1 = almost never to 5 = almost always). A total score of self-compassion was determined by adding the means of all six sub-scales together and dividing by six (Neff, 2003b). Scores from this scale have good test-retest reliability (r = .80-.93) with high internal consistency (α = .92; Neff, 2003b). A sample item includes: "When things are going badly for me, I see the difficulties as part of life that everyone goes through".
Time frame: Assessed at baseline and 1-week post-intervention
Health Anxiety
Health anxiety subscale of the Multidimensional Health Questionnaire (Snell \& Johnson,1997): This scale consists of five items assessing participants' health anxiety on a 5-point Likert scale (1 = not at all characteristic of me to 5 = very characteristic of me). A mean score is created to capture overall health anxiety. The Multidimensional Health Questionnaire is reliable and validated (Snell \& Johnson, 1997). A sample item is: "I feel anxious when I think about my health".
Time frame: Assessed at baseline and 1-week post-intervention
Illness Self-Blame
Illness self-blame subscale of the Multidimensional Health Questionnaire (Snell \& Johnson, 1997): This reliable and validated measure (Snell \& Johnson, 1997) uses five items rated on a 5-point Likert scale (1 = not at all characteristic of me to 5 = very characteristic of me) to create a mean illness self-blame score (Snell \& Johnson, 1997). A sample item is: "When I become sick or ill, I am the person to blame".
Time frame: Measured during Session 1 and at 1-week post-intervention
State Rumination
State Rumination Scale (Puterman et al., 2010): Participants responded to three items with a 5-point Likert scale (1= Not at all to 5 = A lot). A mean score was calculated to capture participants' state rumination about having a heart health risk. This scale is reliable and valid (Puterman et al., 2010). A sample item is: "Did you find it hard to stop thinking about your risk for heart disease afterwards?"
Time frame: Measured during Session 1 and at 1-week post-intervention
Negative Affect
Assessment of Negative Affect (Terry et al., 2013): Participants responded to 13 items using a 5-point Likert scale (1=not at all to 5=extremely). A mean score was calculated to assess negative affect about having a heart health risk. This measure has been used in other self-compassion research (Terry et al., 2013). A sample item is: "Rate the extent to which you feel sad about your risk for heart disease".
Time frame: Measured during Session 1 and at 1-week post-intervention
Health Promoting Behaviours
Health Promoting Lifestyle Profile-II (Walker \& Hill-Polerecky, 1996): Participants responded to 52 questions about their engagement in various health-promoting behaviours using a 4-point Likert scale (1 = Never to 4 = Routinely). A mean score was calculated for each subscale, and a grand mean was calculated to assess overall health-promoting behaviours. This scale has demonstrated high internal consistency (Walker \& Hill-Polerecky, 1996). Participants were asked to respond to the frequency with which they engage in different behaviours, such as "Choose a diet low in fat, saturated fat, and cholesterol."
Time frame: Assessed at baseline and 1-week post-intervention
Physical Activity
Short-form International Physical Activity Questionnaire (Craig et al, 2003): Participants reported the number of days they engaged in each intensity of physical activity and the average duration of each session. This is a reliable and valid measure (Lee et al., 2011). We used the International Physical Activity Questionnaire to calculate participants' weekly minutes of moderate-to-vigorous physical activity. A sample item includes: "During the last 7 days, how many bouts of 10 minutes or more did you complete of vigorous physical activities like heavy lifting, digging, aerobics, or fast bicycling?".
Time frame: Assessed at baseline and 1-week post-intervention
Plan to share: Yes — Anonymized data can be made available upon request by contacting the corresponding author. Individual Participant Data includes anonymized raw survey data in the form of Excel spreadsheets, anonymized participant quotations from qualitative interviews (Microsoft Word documents), and researcher observations of the feasibility criteria (Microsoft Word documents and Excel Spreadsheets).
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University of Manitoba