Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799899
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2021-03-12
Brief Title:
MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms A Pilot RCT
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 A Pilot RCT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
The aim of this study is to establish in a pilot RCT approx N50 participants with a time- and attention-matched health enhancement control a the feasibility of the recruitment procedures screening eligibility enrollment rates and feasibility and acceptability of the b MBCT and control interventions adherence retention fidelity satisfaction group videoconferencing delivery and c data collection procedures by group adherence satisfaction Hypothesis 1a Recruitment will be feasible as evidenced by screening eligibility and enrollment rates 1b the MBCT and control interventions and 1c data collection procedures in both groups will be feasible and acceptable
Detailed Description:
The current study will employ an open pilot RCT with a time-and-attention-matched health control group to determine the feasibility and acceptability of a virtual MBCT intervention for ACS patients The investigators plan to enroll approximately N50 participants approx 3 MBCT groups and approx 3 health enhancement control groups with approximately 6-7 participants per group accounting for 20 attrition Participants will be randomized to a MBCT or a time- and attention-matched health enhancement control in a 11 design using a random number generator Participants will then be stratified by antidepressant medication use 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 The health enhancement control group will follow the same structure of the MBCT intervention eg 8 virtually-delivered MBCT sessions approximately 15 hours each and will educate participants on depression and cardiac health eg relationship between depression and cardiac health cardiac risk factors cardiac health behaviors finding resources for mental health care 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 30-60 minutes
Participants will be recruited through EPIC 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 informed consent with study staff prior to enrollment
Participants will be enrolled in either one of three MBCT intervention cohorts approx or one of three health enhancement control cohorts approx Participants in all of these groups will be expected to participate in 8-weekly 15-hour virtual sessions Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice Participants in the health enhancement control group will be expected to review educational videos or readings between sessions A licensed mental health provider eg LICSW PhD trained in the MBCT protocol will delivered the intervention to the MBCT intervention group A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group Both the MBCT intervention and health enhancement control groups will be delivered via Zoom 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 for the MBCT-intervention group home practice logs submitted between each intervention session Primary outcomes for the intervention are feasibility and acceptability Exploratory outcomes are changes in emotional and biological variables Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations
Participants will be recruited through EPIC 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 informed consent with study staff prior to enrollment
Participants will be enrolled in either one of three MBCT intervention cohorts approx or one of three health enhancement control cohorts approx Participants in all of these groups will be expected to participate in 8-weekly 15-hour virtual sessions Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice Participants in the health enhancement control group will be expected to review educational videos or readings between sessions A licensed mental health provider eg LICSW PhD trained in the MBCT protocol will delivered the intervention to the MBCT intervention group A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group Both the MBCT intervention and health enhancement control groups will be delivered via Zoom 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 for the MBCT-intervention group home practice logs submitted between each intervention session Primary outcomes for the intervention are feasibility and acceptability Exploratory outcomes are changes in emotional and biological variables Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations
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