Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03878160
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2019-02-26
Brief Title:
MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression 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 Elevated Depression Symptoms
Status:
COMPLETED
Status Verified Date:
2021-05
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 objective of this study is to identify Acute Coronary Syndromes ACS patients specific needs and preferences for depression treatment via in-person or virtual individual interviews to a guide MBCT adaptation and identify barriers and facilitators to b group videoconferencing delivery and c blood spot data collection to enhance feasibility Through qualitative measures participants will report specific physical cognitive and behavioral symptoms to be targeted in the intervention discuss barriers and facilitators to participating in a video-conference treatment program and completing blood spot data collection procedures
Detailed Description:
This is a qualitative research study that will involve individual interviews of ACS patients with elevated depression symptoms stratified by time since ACS 2 years and 2 years post ACS N10 participants per strata to explore patients treatment needs and preferences for an adapted MBCT intervention and barriers and facilitators for future intervention research procedures ie videoconferencing delivery of the intervention and collection of dried blood spots It will also involve individual interviews of ACS patients without elevated depression symptoms N10 to better understand the needs of ACS patients who are interested in treatment but not currently depressed in order to inform future outreach and treatment development efforts total N30 Interviews will be conducted either in person by phone or by video conference
Participants will be recruited in several ways First participants will be identified using the MGH Research Patient Data Registry RPDR Participants will be pre-screened for eligibility and sent an opt-out letter Patients will have the option to opt out via phone or email Patients who do not opt out and meet eligibility requirements will be contacted via phone Over the phone patients who express interest in the study will complete an eligibility screen patients who meet study eligibility criteria will then complete a verbal consent to enroll in the study Second patients will be recruited through advertisements eg flyers brochures placed throughout inpatient andor outpatient hospital clinics community mental health clinics community businesses eg coffee shops and social media platforms The advertisements will ask patients to contact study staff if they are interested in learning more about the study and the screening procedures will be the same as those described above for RPDR patients Lastly patients will be recruited via direct referrals from their providers eg cardiologists psychiatrists We will inform providers about the study eg via short presentations at their team meetings and provide them with advertisement materials to give to their patients The patients may either contact study staff directly using the information their provider gave them andor the provider will contact the study team with the patients information so that the study team may reach out to the patient Providers will obtain verbal permission from the patient for the research team to contact them
Once enrolled participants will partake in a semi-structured in-person individual interview Individual interviews will be stratified by time since ACS and depressive symptoms and will explore a emotional symptoms b health behavior challenges c specific preferences for the MBCT intervention and d potential barriers and facilitators of group videoconferencing and e blood spot data collection Participants will also complete a survey detailing depression symptoms trait mindfulness health behaviors and other psychological behavioral and physical constructs that may potentially be impacted by the MBCT intervention in subsequent trials will be measured Data collected from the individual interviews will be used to guide MBCT adaptations and research procedures for future clinical trials
Participants will be recruited in several ways First participants will be identified using the MGH Research Patient Data Registry RPDR Participants will be pre-screened for eligibility and sent an opt-out letter Patients will have the option to opt out via phone or email Patients who do not opt out and meet eligibility requirements will be contacted via phone Over the phone patients who express interest in the study will complete an eligibility screen patients who meet study eligibility criteria will then complete a verbal consent to enroll in the study Second patients will be recruited through advertisements eg flyers brochures placed throughout inpatient andor outpatient hospital clinics community mental health clinics community businesses eg coffee shops and social media platforms The advertisements will ask patients to contact study staff if they are interested in learning more about the study and the screening procedures will be the same as those described above for RPDR patients Lastly patients will be recruited via direct referrals from their providers eg cardiologists psychiatrists We will inform providers about the study eg via short presentations at their team meetings and provide them with advertisement materials to give to their patients The patients may either contact study staff directly using the information their provider gave them andor the provider will contact the study team with the patients information so that the study team may reach out to the patient Providers will obtain verbal permission from the patient for the research team to contact them
Once enrolled participants will partake in a semi-structured in-person individual interview Individual interviews will be stratified by time since ACS and depressive symptoms and will explore a emotional symptoms b health behavior challenges c specific preferences for the MBCT intervention and d potential barriers and facilitators of group videoconferencing and e blood spot data collection Participants will also complete a survey detailing depression symptoms trait mindfulness health behaviors and other psychological behavioral and physical constructs that may potentially be impacted by the MBCT intervention in subsequent trials will be measured Data collected from the individual interviews will be used to guide MBCT adaptations and research procedures for future clinical trials
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23AT009715-01A1 | NIH | None | httpsreporternihgovquickSearch1K23AT009715-01A1 |