Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04231097
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2020-01-10
Brief Title:
MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
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:
Brief Summary The aim of this study is to explore the initial feasibility and acceptability of a Mindfulness-Based Cognitive Therapy MBCT adapted for ACS patients b the group videoconferencing delivery medium and c dried blood spot research procedures to inform refinements for a subsequent pilot RCT
Detailed Description:
The current study will employ an open pilot trial to determine the initial feasibility and acceptability of a targeted virtual MBCT intervention for ACS patients The investigators plan to enroll approximately N20 patients 2 cohorts of 10 participantsper cohort accounting for 20 anticipated lost to follow-up The MBCT intervention will involve 8 virtually-delivered MBCT sessions approximately 15 hours each during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors as well as learn about cardiac health Participants will be asked to complete a brief survey following each session Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples Upon completion of the intervention participants will complete an audio-or video recorded exit interview approximately 30 minutes
Participants will be recruited through the the hospitals clinical data registry advertisements eg flyers brochures placed throughout the hospital direct provider referrals and from inpatient cardiac units Patients who express interest in the study will be asked complete an eligibility screening Eligible patients agreeable with study participation will then complete a written consent with study staff prior to enrollment
Participants will be enrolled in one of two MBCT intervention cohorts and expected to participate in 8-weekly 15-hour virtual sessions in conjunction with approximately 30 minutes of at-home daily practice A licensed mental health provider eg LICSW PhD trained in the MBCT protocol will deliver the intervention The MBCT intervention will be delivered Zoom a secure HIPPA-compliant video-conferencing software
Study assessments will include a battery of self-report surveys administered at baseline post-intervention and 3-month follow-up session satisfaction surveys administered after each intervention session post-intervention individual exit interviews conducted via telephone or videoconference blood spot samples self-collected by participants at baseline post-intervention and 3-month follow-up submitted to the research team via paper mail and home practice logs submitted between each intervention session Primary outcomes for the intervention are feasibility and acceptability Data collected from the study will be used to assist in the development of future RCTs
Participants will be recruited through the the hospitals clinical data registry advertisements eg flyers brochures placed throughout the hospital direct provider referrals and from inpatient cardiac units Patients who express interest in the study will be asked complete an eligibility screening Eligible patients agreeable with study participation will then complete a written consent with study staff prior to enrollment
Participants will be enrolled in one of two MBCT intervention cohorts and expected to participate in 8-weekly 15-hour virtual sessions in conjunction with approximately 30 minutes of at-home daily practice A licensed mental health provider eg LICSW PhD trained in the MBCT protocol will deliver the intervention The MBCT intervention will be delivered Zoom a secure HIPPA-compliant video-conferencing software
Study assessments will include a battery of self-report surveys administered at baseline post-intervention and 3-month follow-up session satisfaction surveys administered after each intervention session post-intervention individual exit interviews conducted via telephone or videoconference blood spot samples self-collected by participants at baseline post-intervention and 3-month follow-up submitted to the research team via paper mail and home practice logs submitted between each intervention session Primary outcomes for the intervention are feasibility and acceptability Data collected from the study will be used to assist in the development of future RCTs
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