Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05209373
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2022-01-10
Brief Title:
Optimizing a Self-compassion Intervention Designed to Improve Physical Activity Among Women at Risk for Heart Disease
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Compassionate And Loving Mindset Towards HEART Health riSk CALM HEARTS 2 A Randomized Optimization Trial
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
In preparation for the proposed research the investigators conducted a one-arm pilot intervention N11 to examine the feasibility and acceptability of a self-compassion intervention for women at risk for cardiovascular disease CVD This pilot study established proof-of-concept Czajkowski et al 2015 for this intervention by producing a clinically significant increase in physical activity M8375 Metabolic Equivalent METminutes per week Florido et al 2018 Further feasibility criteria for recruitment time 1 week retention rate 100 and completion of study measures 97 successfully exceeded the pre-established standards Exit surveys found the intervention was 100 acceptable to participants These results are encouraging yet questions remain about how best to deliver the intervention and with whom
An optimization trial is the appropriate iterative step that will refine the present feasible and acceptable intervention with established proof of concept prior to conducting an efficacy trial The present optimization trial will advance a research program informed by The ORBIT Model for Behavioural Treatment Development Czajkowski et al 2015 Two identified shortcomings of the pilot intervention will be targeted for optimization
Primary Optimization Target The pilot intervention was delivered individually to each participant For 11 participants to complete the study 33 individual meetings totalling over 40 hours were required over three weeks This resource intensive delivery method may not be practical Delivering the intervention to small groups would be more practical Therefore the primary objective of this optimization trial is to determine if a self-compassion intervention delivered in small groups is at least as effective at increasing physical activity among women at risk for CVD compared to a self-compassion intervention delivered individually The investigators hypothesize that group delivery should be at least as effective as individual delivery at increasing physical activity
Secondary Optimization Target The previous pilot intervention only included women with CVD risk who were low on self-compassion While women low on self-compassion are an obvious intervention target women with moderate or high self-compassion may also benefit from learning to apply their self-compassion to their CVD risk and physical activity efforts No research exists to inform the effectiveness of self-compassion interventions when delivered to participants low moderate and high on self-compassion Therefore the secondary objective of this optimization trial is to determine if baseline self-compassion influences physical activity behavioural outcomes or psychological outcomes of the intervention The investigators hypothesize that participants at all levels of self-compassion should benefit similarly from the intervention Finally the tertiary objective is to determine if delivery mode and self-compassion interact such that one method of delivery group or individual is better suited to women at low moderate or high self-compassion This outcome is exploratory only and the researchers put forth no hypothesis
Trial Design This intervention was developed with the Consolidated Standards of Reporting Trials CONSORT guidelines Schulz et al 2010 This is a two-armed optimization trial with 11 randomization to be conducted in a single centre in Manitoba Canada Women at risk for CVD will be randomized to receive a combined physical activity behaviour change plus self-compassion intervention in small groups intervention condition or individually with a facilitator control condition The individual condition serves as a positive control against which the effectiveness of the group condition at increasing physical activity will be judged The intervention will be delivered to both conditions via an institution-sponsored videoconferencing platform Data will be collected at pre- and post-intervention using validated surveys completed online The investigators often use this data collection approach
Participants Participants will be women at risk for CVD identified through the Womens Advanced Risk-assessment in Manitoba WARM Hearts Cohort NCT03938155 a large ongoing prospective study to improve CVD risk detection in Manitoban women Participants identified through pre-screening will be contacted by telephone and invited to participate in the study Interested individuals will be sent an online questionnaire by email to assess the study eligibility criteria Eligible individuals will be stratified by self-compassion score and sampled to equally enroll participants scoring low moderate and high on self-compassion This recruitment strategy is required for the planned method of statistical analysis
Randomization Participants will be randomly allocated to the two intervention conditions with a 11 ratio 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
Intervention Participants will engage in four weekly one-hour sessions delivered by research assistants trained in self-compassion six-week course Both facilitators will deliver interventions to a similar number of participants in both conditions by alternating between conditions every four weeks Intervention delivery will be guided by a script to prevent drift To ensure facilitator fidelity 20 of all intervention sessions will be recorded and shared with a self-compassion expert for feedback This intervention draws from the Mindful Self-Compassion Program Neff Germer 2013 and was developed by self-compassion experts
Participants in the group condition will complete the four weekly sessions with six to nine other participants plus a facilitator those in the individual condition will meet individually with a facilitator Both conditions will be exposed to identical intervention content
In Session One participants will discuss risk factors for CVD be advised of the Canadian 24-Hour Movement Guidelines Ross et al 2020 and guided to set a physical activity goal using the SMART goals framework American College of Sports Medicine 2017
In Session Two participants will apply the three components of self-compassion self-kindness mindfulness and common humanity Neff 2003 to their CVD risk and physical activity efforts
In Session Three participants will learn to use the Yin gentle Neff 2003 side of self-compassion to cope with difficult emotions and the Yang fierce Neff 2003 side of self-compassion to improve their health through physical activity
In Session Four participants will use the mindful practices of savouring and gratitude Neff 2003 to find enjoyment in physical activity
Identical self-compassion writing exercises will be assigned to both conditions as home practice after Sessions 2-4
Outcomes Reliable and valid measures will be distributed using SurveyMonkey wwwmomentiveai at pre-intervention and post-intervention
Statistics The sample required to achieve statistical power is 82 participants The power analysis was conducted based on data showing that 10-minute increases in daily moderate to vigorous physical activity significantly lower CVD risk Glazer et al 2013 To protect against approximately 15 attrition Ferrari et al 2019 96 participants will be enrolled in the trial
Analyses will employ a 2 by 3 factorial ANOVA to address the three study objectives Each factor in a factorial ANOVA is controlled for within the combinations of factors tested The primary objective of the study is to determine if the group condition intervention condition is at least as effective as the individual condition control condition at increasing physical activity The factorial ANOVA will test for main effects of the group condition on post-intervention physical activity across all levels of self-compassion controlling for effects of the individual condition The secondary and tertiary objectives of this study are to determine if baseline self-compassion influences how women respond to the intervention and if delivery method and self-compassion interact such that one method of delivery is better suited to women higher or lower in self-compassion The factorial ANOVA will explore main and interaction effects between baseline self-compassion low moderate high and intervention condition group or individual on physical activity behavioural outcomes and psychological outcomes
An optimization trial is the appropriate iterative step that will refine the present feasible and acceptable intervention with established proof of concept prior to conducting an efficacy trial The present optimization trial will advance a research program informed by The ORBIT Model for Behavioural Treatment Development Czajkowski et al 2015 Two identified shortcomings of the pilot intervention will be targeted for optimization
Primary Optimization Target The pilot intervention was delivered individually to each participant For 11 participants to complete the study 33 individual meetings totalling over 40 hours were required over three weeks This resource intensive delivery method may not be practical Delivering the intervention to small groups would be more practical Therefore the primary objective of this optimization trial is to determine if a self-compassion intervention delivered in small groups is at least as effective at increasing physical activity among women at risk for CVD compared to a self-compassion intervention delivered individually The investigators hypothesize that group delivery should be at least as effective as individual delivery at increasing physical activity
Secondary Optimization Target The previous pilot intervention only included women with CVD risk who were low on self-compassion While women low on self-compassion are an obvious intervention target women with moderate or high self-compassion may also benefit from learning to apply their self-compassion to their CVD risk and physical activity efforts No research exists to inform the effectiveness of self-compassion interventions when delivered to participants low moderate and high on self-compassion Therefore the secondary objective of this optimization trial is to determine if baseline self-compassion influences physical activity behavioural outcomes or psychological outcomes of the intervention The investigators hypothesize that participants at all levels of self-compassion should benefit similarly from the intervention Finally the tertiary objective is to determine if delivery mode and self-compassion interact such that one method of delivery group or individual is better suited to women at low moderate or high self-compassion This outcome is exploratory only and the researchers put forth no hypothesis
Trial Design This intervention was developed with the Consolidated Standards of Reporting Trials CONSORT guidelines Schulz et al 2010 This is a two-armed optimization trial with 11 randomization to be conducted in a single centre in Manitoba Canada Women at risk for CVD will be randomized to receive a combined physical activity behaviour change plus self-compassion intervention in small groups intervention condition or individually with a facilitator control condition The individual condition serves as a positive control against which the effectiveness of the group condition at increasing physical activity will be judged The intervention will be delivered to both conditions via an institution-sponsored videoconferencing platform Data will be collected at pre- and post-intervention using validated surveys completed online The investigators often use this data collection approach
Participants Participants will be women at risk for CVD identified through the Womens Advanced Risk-assessment in Manitoba WARM Hearts Cohort NCT03938155 a large ongoing prospective study to improve CVD risk detection in Manitoban women Participants identified through pre-screening will be contacted by telephone and invited to participate in the study Interested individuals will be sent an online questionnaire by email to assess the study eligibility criteria Eligible individuals will be stratified by self-compassion score and sampled to equally enroll participants scoring low moderate and high on self-compassion This recruitment strategy is required for the planned method of statistical analysis
Randomization Participants will be randomly allocated to the two intervention conditions with a 11 ratio 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
Intervention Participants will engage in four weekly one-hour sessions delivered by research assistants trained in self-compassion six-week course Both facilitators will deliver interventions to a similar number of participants in both conditions by alternating between conditions every four weeks Intervention delivery will be guided by a script to prevent drift To ensure facilitator fidelity 20 of all intervention sessions will be recorded and shared with a self-compassion expert for feedback This intervention draws from the Mindful Self-Compassion Program Neff Germer 2013 and was developed by self-compassion experts
Participants in the group condition will complete the four weekly sessions with six to nine other participants plus a facilitator those in the individual condition will meet individually with a facilitator Both conditions will be exposed to identical intervention content
In Session One participants will discuss risk factors for CVD be advised of the Canadian 24-Hour Movement Guidelines Ross et al 2020 and guided to set a physical activity goal using the SMART goals framework American College of Sports Medicine 2017
In Session Two participants will apply the three components of self-compassion self-kindness mindfulness and common humanity Neff 2003 to their CVD risk and physical activity efforts
In Session Three participants will learn to use the Yin gentle Neff 2003 side of self-compassion to cope with difficult emotions and the Yang fierce Neff 2003 side of self-compassion to improve their health through physical activity
In Session Four participants will use the mindful practices of savouring and gratitude Neff 2003 to find enjoyment in physical activity
Identical self-compassion writing exercises will be assigned to both conditions as home practice after Sessions 2-4
Outcomes Reliable and valid measures will be distributed using SurveyMonkey wwwmomentiveai at pre-intervention and post-intervention
Statistics The sample required to achieve statistical power is 82 participants The power analysis was conducted based on data showing that 10-minute increases in daily moderate to vigorous physical activity significantly lower CVD risk Glazer et al 2013 To protect against approximately 15 attrition Ferrari et al 2019 96 participants will be enrolled in the trial
Analyses will employ a 2 by 3 factorial ANOVA to address the three study objectives Each factor in a factorial ANOVA is controlled for within the combinations of factors tested The primary objective of the study is to determine if the group condition intervention condition is at least as effective as the individual condition control condition at increasing physical activity The factorial ANOVA will test for main effects of the group condition on post-intervention physical activity across all levels of self-compassion controlling for effects of the individual condition The secondary and tertiary objectives of this study are to determine if baseline self-compassion influences how women respond to the intervention and if delivery method and self-compassion interact such that one method of delivery is better suited to women higher or lower in self-compassion The factorial ANOVA will explore main and interaction effects between baseline self-compassion low moderate high and intervention condition group or individual on physical activity behavioural outcomes and psychological outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None