Applying Self-compassion to Women's Heart Health: A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Feasibility Domain 3: Fidelity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants were identified through the Women's Advanced Risk-assessment in Manitoba (WARM) Hearts Cohort (Rose et al., 2021).
- •Female sex is an inclusion criterion of the WARM Hearts Cohort. Therefore, all participants eligible for the CALM Hearts intervention were female.
- •Aged 55 to 75 years
- •Engaged in less than 150 minutes of weekly moderate-to-vigorous physical activity (i.e., not meeting the Canadian Physical Activity guidelines).
- •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.
- •Scored moderate to low on the 26-item self-compassion scale (1 to 3.6 / 5; Neff, 2003)
排除标准
- •Not meeting the inclusion criteria
结局指标
主要结局
Feasibility Domain 3: Fidelity
时间窗: Assessed from baseline to 1-week post-intervention
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
Acceptability of the CALM Hearts Intervention
时间窗: Assessed at 1-week post-intervention
Acceptability will be assessed using post-intervention interviews and open-ended surveys administered to participants. Suggestions for increasing acceptability will be noted.
Safety of the CALM Hearts Intervention
时间窗: Assessed at 1-week post-intervention
Safety will be assessed using post-intervention interviews and open-ended surveys administered to participants. The criterion for safety = 100% safe.
Feasibility Domain 2: Retention and Adherence
时间窗: Assessed from baseline to 1-week post-intervention
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
Feasibility Domain 1: Recruitment
时间窗: Assessed from baseline to 1-week post-intervention
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
Feasibility Domain 4: Capacity
时间窗: Assessed from baseline to 1-week post-intervention
Capacity will be assessed using the following criteria: \- Time required to deliver all aspects of the intervention. Criterion = Observe and report
次要结局
- Health Anxiety(Assessed at baseline and 1-week post-intervention)
- State Rumination(Measured during Session 1 and at 1-week post-intervention)
- Negative Affect(Measured during Session 1 and at 1-week post-intervention)
- Health Promoting Behaviours(Assessed at baseline and 1-week post-intervention)
- Physical Activity(Assessed at baseline and 1-week post-intervention)
- Self-Compassion(Assessed at baseline and 1-week post-intervention)
- Illness Self-Blame(Measured during Session 1 and at 1-week post-intervention)