A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
NCT ID: NCT06576349
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2021-01-04
2021-02-10
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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CALM Hearts Self-Compassion Intervention for Women at Risk for Heart Disease
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
55 Years
75 Years
FEMALE
No
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Locations
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Faculty of Kinesiology and Recreation Management, University of Manitoba
Winnipeg, Manitoba, Canada
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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(# E2019:029 [HS22733])
Identifier Type: -
Identifier Source: org_study_id
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