Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576349
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Applying Self-compassion to Womens Heart Health A Single-arm Pilot and Feasibility Study of the CALM Hearts Intervention
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 httpswwwsurveymonkeycom and will receive a fillable online workbook to complete throughout the intervention The CALM Hearts intervention will be conducted individually ie 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 participants 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 ie 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
After consenting participants will complete baseline measures housed on SurveyMonkey httpswwwsurveymonkeycom and will receive a fillable online workbook to complete throughout the intervention The CALM Hearts intervention will be conducted individually ie 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 participants 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None