A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
NCT Number: NCT06576349
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Self-Compassion|Physical Inactivity|Cardiovascular Diseases
Interventions: BEHAVIORAL: Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention
Sponsor: University of Manitoba
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 11
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2021-01-04
Completion Date: 2021-02-10
Locations: Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, Manitoba, R3T 2N2, Canada

Summary:
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

Primary Outcome Measures: 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, 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, 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, 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, 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., 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., Assessed at 1-week post-intervention
Secondary Outcome Measures: 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"., 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"., 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"., 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?", 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"., 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.", 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?"., Assessed at baseline and 1-week post-intervention