Optimizing a Self-compassion Intervention Designed to Improve Physical Activity Among Women at Risk for Heart Disease

NCT05209373 | Unknown

• 1 other identifier: HE2021-0175
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to optimize an intervention which teaches women at risk for cardiovascular disease (CVD) to cope with this risk using self-compassion (an attitude of kindness towards oneself) in order to adopt a physically active lifestyle. The investigators previously conducted a one-on-one self-compassion intervention for 11 women with CVD risk that successfully increased physical activity. However, meeting one-on-one with each participant was time and resource intensive. The primary purpose of the present study is to determine if group self-compassion intervention delivery is comparably effective to one-on-one delivery for increasing physical activity among women at risk for CVD. The investigators hypothesize that group delivery should be at least as effective as individual delivery at increasing physical activity. Furthermore, only women low in self-compassion were included in the previous study. The secondary purpose of the present study is to determine if women higher in self-compassion can also benefit from the intervention. The investigators hypothesize that participants at all levels of self-compassion should benefit similarly from the intervention. Finally, the tertiary purpose is to determine if delivery mode and self-compassion interact such that one method of delivery (group or one-on-one) is better suited to women at low, moderate, or high self-compassion. This outcome is exploratory only and the researchers present no hypothesis. The present study follows the methods of a randomized optimization trial. Women at risk for CVD will be randomly assigned to receive four sessions of combined physical activity behaviour change and self-compassion training in groups of six to nine or through one-on-one delivery. The intervention will provide one session to discuss participants' CVD risk and physical activity goals, and then three sessions of self-compassion training. Outcome measures will be assessed pre- and post-intervention. The effectiveness of the one-on-one and group conditions for improving the study outcomes will be examined. The present research will determine how best to deliver an intervention which teaches women to cope with their CVD risk using self-compassion in order to become more physically active. The results of the present study will inform an eventual efficacy trial.

Conditions

Cardiovascular Diseases

Keywords

self-compassion; physical activity; self-regulation; randomized optimization trial; emotions

Outcome Measures

Primary Outcomes (1)

• Differences between groups in moderate to vigorous physical activity from pre-intervention to post-intervention

  International Physical Activity Questionnaire (Craig et al., 2003). Seven items to measure frequency and duration of weekly walking, moderate physical activity, and vigorous physical activity, and sitting.

  Post-intervention (4 week time point)

Secondary Outcomes (5)

• Differences between groups in self-compassion from pre-intervention to post-intervention

  Post-intervention (4 week time point)

• Differences between groups in general health promoting behaviours from pre-intervention to post-intervention

  Post-intervention (4 week time point)

• Differences between groups in health anxiety and illness self-blame from pre-intervention to post-intervention

  Post-intervention (4 week time point)

• Differences between groups in health behaviour intentions from pre-intervention to post-intervention

  Post-intervention (4 week time point)

• Personal Growth Initiative as a potential mediator

  Post-intervention (4 week time point)

Study Arms (2)

Group-Delivered Self-Compassion Intervention

EXPERIMENTAL

A 4-week intervention pairing behaviour change and self-compassion education, aimed to increase physical activity and help women cope with their risk of cardiovascular disease. Participants in the group condition will complete Sessions 2-4 with 6-9 other participants plus a facilitator. Both conditions will be exposed to identical intervention content. All intervention sessions will be hosted on an institution-sponsored Zoom videoconferencing account. Week 1, Session 1 (60 minutes): Participants will meet in their group to discuss CVD risk factors and set physical activity goals. Weeks 2-4, Sessions 2-4 (60 minutes each): Participants will meet in their group to receive self-compassion education to aimed at encouraging adaptive coping with cardiovascular risk and physical activity behaviour change. Brief self-compassionate writing exercises will be assigned as home practice after Sessions 2-4.

Behavioral: Intervention Condition

Positive control condition: Individually-Delivered Self-Compassion Intervention

OTHER

A 4-week intervention pairing behaviour change and self-compassion education, aimed to increase physical activity and help women cope with their risk of cardiovascular disease. Participants in the individual condition will complete Sessions 2-4 individually with a facilitator. Both conditions will be exposed to identical intervention content. All intervention sessions will be hosted on an institution-sponsored Zoom videoconferencing account. Week 1, Session 1 (60 minutes): Participants will meet individually with a facilitator to discuss CVD risk factors and set physical activity goals. Weeks 2-4, Sessions 2-4 (60 minutes each): Participants will meet individually with a facilitator to receive self-compassion education to aimed at encouraging adaptive coping with cardiovascular risk and physical activity behaviour change. Brief self-compassionate writing exercises will be assigned as home practice after Sessions 2-4.

Behavioral: Positive Control Condition

Interventions

Intervention Condition BEHAVIORAL

4-week intervention combining behaviour change and self-compassion education to promote coping with CVD risk and increased engagement in physical activity.

Group-Delivered Self-Compassion Intervention

Positive Control Condition BEHAVIORAL

4-week intervention combining behaviour change and self-compassion education to promote coping with CVD risk and increased engagement in physical activity.

Positive control condition: Individually-Delivered Self-Compassion Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years or older
• Flagged response on CANHEART Index (Maclagan et al., 2014) (response of "yes" to having high blood pressure)
• Insufficient self-reported physical activity relative to guidelines of 150 minutes of moderate to vigorous physical activity per week.
• No current or planned enrolment in programming similar to the intervention
• No current diagnosis of cardiovascular disease
• No medical conditions that make it unsafe to engage in physical activity
• Available for all intervention sessions
• Comfortable using videoconferencing
• Comfortable reading and communicating in English
• Score on the self-compassion scale will be monitored in order to ensure equal enrolment of participants scoring low, moderate, and high on the self-compassion scale (Neff, 2021). Eligibility criteria may be adjusted according to self-compassion score in order to represent the full range of possible self-compassion scores.

You may not qualify if:

• Being under 50 years old
• No flagged response on CANHEART Index (Maclagan et al., 2014) (response of "no" to having high blood pressure)
• Self-report meeting or exceeding guidelines of 150 minutes of moderate to vigorous physical activity per week.
• Current or planned enrolment in programming similar to the intervention
• Current diagnosis of cardiovascular disease
• Medical conditions that make it unsafe to engage in physical activity
• Not available for all intervention sessions
• Not comfortable using videoconferencing
• No comfortable reading and communicating in English

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

The University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (18)

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  BACKGROUND

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• Neff, K. D., Tóth-Király, I., Knox, M. C., Kuchar, A., & Davidson, O. (2021). The Development and Validation of the State Self-Compassion Scale (Long- and Short Form). Mindfulness, 12(1). https://doi.org/10.1007/s12671-020-01505-4

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  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity; Self-Control

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A third-party with no involvement in intervention delivery or data analysis will use a random numbers list generated by the IBM Statistical Package for the Social Sciences (SPSS) 28© (statistical software) to allocate participants to the two intervention conditions. The random number list will not be accessible to research staff involved in recruitment and intervention delivery. The results of allocation will not be revealed until participants begin the intervention sessions in their respective conditions. Complete blinding of facilitators and participants is not possible; facilitators and participants will know if they are in the individual or group condition but will be blind to participants' pre-intervention self-compassion score.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: January 9, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)