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Self-CompassionNCT06576349

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

A study testing Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention in people with Self-Compassion and Physical Inactivity, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 years, women only
What is being tested?
Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteCanada
Study dates
4 Jan 2021to 10 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Not meeting the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Faculty of Kinesiology and Recreation Management, University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Official title: Applying Self-compassion to Women's Heart Health: A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention

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.

Read more

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

Read the 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.

Being tested
Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention
Keywords
Self-compassion, physical activity, heart disease, cardiovascular disease, women, women's health, self-regulation, coping, feasibility, acceptability, pilot study, single-arm
Medical subject headings
Sedentary Behavior, Cardiovascular Diseases, Motor Activity, Heart Diseases, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) InterventionBehavioural

    Also called CALM Hearts

    Self-compassion and health behaviour change intervention for women at risk for cardiovascular disease

Study groups in NCT06576349
Study groupRoleWhat they receive
CALM Hearts Self-Compassion Intervention for Women at Risk for Heart DiseaseExperimentalThe 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.
Receives: Behavioral: Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Assessed from baseline to 1-week post-intervention

  2. 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

    Measured: Assessed from baseline to 1-week post-intervention

  3. 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

    Measured: Assessed from baseline to 1-week post-intervention

  4. 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

    Measured: Assessed from baseline to 1-week post-intervention

  5. 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.

    Measured: Assessed at 1-week post-intervention

  6. 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.

    Measured: Assessed at 1-week post-intervention

Secondary outcomes (7)

  1. 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".

    Measured: Assessed at baseline and 1-week post-intervention

  2. 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".

    Measured: Assessed at baseline and 1-week post-intervention

  3. 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: Measured during Session 1 and at 1-week post-intervention

  4. 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: Measured during Session 1 and at 1-week post-intervention

  5. 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: Measured during Session 1 and at 1-week post-intervention

  6. 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."

    Measured: Assessed at baseline and 1-week post-intervention

  7. 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?".

    Measured: Assessed at baseline and 1-week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start4 Jan 2021
  3. Primary completion10 Feb 2021
  4. Study completion10 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
single-arm, multiple-methods, pilot and feasibility study
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06576349
Sponsor's protocol ID
(# E2019:029 [HS22733])
Status last verified
Aug 2024
First submitted
20 Aug 2024
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Publications

  • 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.

    PubMed 34035097

  • 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.

    PubMed 33054332

  • Neff, K. D. (2003). The Development and Validation of a Scale to Measure Self-Compassion. Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027

  • Snell, W. E., & Johnson, G. (1997). The Multidimensional Health Questionnaire. American Journal of Health Behavior, 21(1), 33-42.

  • Puterman, E., DeLongis, A., & Pomaki, G. (2010). Protecting us from ourselves: Social support as a buffer of trait and state rumination. Journal of Social and Clinical Psychology, 29(7), 797-820. doi:10.1521/jscp.2010.29.7.797

  • Terry ML, Leary MR, Mehta S, Henderson K. Self-compassionate reactions to health threats. Pers Soc Psychol Bull. 2013 Jul;39(7):911-26. doi: 10.1177/0146167213488213.

    PubMed 23813424

  • Walker, S.N., & Hill-Polerecky, D.M. (1996). Psychometric evaluation of the Health-Promoting Lifestyle Profile II. Unpublished manuscript, University of Nebraska Medical Center.

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694

  • Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

    PubMed 22018588

Questions about this trial

What is this clinical trial studying?

A study testing Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention in people with Self-Compassion and Physical Inactivity, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Domain 1: Recruitment (time frame: Assessed from baseline to 1-week post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06576349, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

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