Clinical trial NCT06576349: A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
Official title: Applying Self-compassion to Women's Heart Health: A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Compassion
Physical Inactivity
Cardiovascular Diseases
Keywords: Self-compassion
physical activity
heart disease
cardiovascular disease
women
women's health
self-regulation
coping
feasibility
acceptability
pilot study
single-arm
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 11
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm, multiple-methods, pilot and feasibility study
Primary purpose: PREVENTION

Brief 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Participants were identified through the Women's Advanced Risk-assessment in Manitoba (WARM) Hearts Cohort (Rose et al., 2021).
2. Female sex is an inclusion criterion of the WARM Hearts Cohort. Therefore, all participants eligible for the CALM Hearts intervention were female.
3. Aged 55 to 75 years
4. Engaged in less than 150 minutes of weekly moderate-to-vigorous physical activity (i.e., not meeting the Canadian Physical Activity guidelines).
5. Had a moderate to high Framingham CVD risk score (D'Agostino et al., 2008), consented to future research contact after participation in the WARM Hearts Cohort.
6. Scored moderate to low on the 26-item self-compassion scale (1 to 3.6 / 5; Neff, 2003)

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: Feasibility Domain 1: Recruitment
timeFrame: Assessed from baseline to 1-week post-intervention
measure: Feasibility Domain 2: Retention and Adherence
timeFrame: Assessed from baseline to 1-week post-intervention
measure: Feasibility Domain 3: Fidelity
timeFrame: Assessed from baseline to 1-week post-intervention
measure: Feasibility Domain 4: Capacity
timeFrame: Assessed from baseline to 1-week post-intervention
measure: Acceptability of the CALM Hearts Intervention
timeFrame: Assessed at 1-week post-intervention
measure: Safety of the CALM Hearts Intervention
timeFrame: Assessed at 1-week post-intervention
Secondary outcomes:
measure: Self-Compassion
timeFrame: Assessed at baseline and 1-week post-intervention
measure: Health Anxiety
timeFrame: Assessed at baseline and 1-week post-intervention
measure: Illness Self-Blame
timeFrame: Measured during Session 1 and at 1-week post-intervention
measure: State Rumination
timeFrame: Measured during Session 1 and at 1-week post-intervention
measure: Negative Affect
timeFrame: Measured during Session 1 and at 1-week post-intervention
measure: Health Promoting Behaviours
timeFrame: Assessed at baseline and 1-week post-intervention
measure: Physical Activity
timeFrame: Assessed at baseline and 1-week post-intervention
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Faculty of Kinesiology and Recreation Management, University of Manitoba
state: Manitoba
Study officials:
References:
citation: Rose AV, Boreskie KF, Hay JL, Thompson L, Arora RC, Duhamel TA. Protocol for the WARM Hearts study: examining cardiovascular disease risk in middle-aged and older women - a prospective, observational cohort study. BMJ Open. 2021 May 25;11(5):e044227. doi: 10.1136/bmjopen-2020-044227.
citation: Ross R, Chaput JP, Giangregorio LM, Janssen I, Saunders TJ, Kho ME, Poitras VJ, Tomasone JR, El-Kotob R, McLaughlin EC, Duggan M, Carrier J, Carson V, Chastin SF, Latimer-Cheung AE, Chulak-Bozzer T, Faulkner G, Flood SM, Gazendam MK, Healy GN, Katzmarzyk PT, Kennedy W, Lane KN, Lorbergs A, Maclaren K, Marr S, Powell KE, Rhodes RE, Ross-White A, Welsh F, Willumsen J, Tremblay MS. Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: an integration of physical activity, sedentary behaviour, and sleep. Appl Physiol Nutr Metab. 2020 Oct;45(10 (Suppl. 2)):S57-S102. doi: 10.1139/apnm-2020-0467.
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