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

NCT06576349 | Completed

• 1 other identifier: (# E2019:029 [HS22733])
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Self-Compassion

  Assessed at baseline and 1-week post-intervention

• Health Anxiety

  Assessed at baseline and 1-week post-intervention

• Illness Self-Blame

  Measured during Session 1 and at 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

Study Arms (1)

CALM Hearts Self-Compassion Intervention for Women at Risk for Heart Disease

EXPERIMENTAL

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.

Behavioral: Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention

Interventions

Compassionate And Loving Mindset towards Heart Health Risk (CALM Hearts) Intervention BEHAVIORAL

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

Also known as: CALM Hearts

CALM Hearts Self-Compassion Intervention for Women at Risk for Heart Disease

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were identified through the Women's Advanced Risk-assessment in Manitoba (WARM) Hearts Cohort (Rose et al., 2021).
• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Faculty of Kinesiology and Recreation Management, University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (9)

• 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.

  PMID: 34035097 BACKGROUND

• 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.

  PMID: 33054332 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23813424 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

• 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.

  PMID: 22018588 BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior; Cardiovascular Diseases; Motor Activity; Heart Diseases; Self-Control

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-arm, multiple-methods, pilot and feasibility study

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: January 4, 2021
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Anonymized data will become available in April 2021. The anonymized data will be stored indefinitely for use in future systematic reviews or meta-analyses and for access during the peer-review process.
• Access Criteria: Anonymized data can be made available upon request by contacting the corresponding author. Data will be shared to support the conduct of future systematic reviews, meta-analyses, or other research that may build upon the CALM Hearts intervention. The principal investigator, Dr. Shaelyn Strachan, will review and approve/decline all requests for data sharing. Data will be shared following the University of Manitoba's data-sharing policies.

Locations

CA (1)