Trial Outcomes & Findings for MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms (NCT NCT03878160)

Results Overview

This portion of the individual interview will focus on exploring changes experienced after an ACS, such as psychosocial changes and health behavior changes. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

one 30-90-minute session

Results posted on

2021-06-04

Participant Flow

Participants were recruited via the MGH Patient Hospital Data Registry, and provider referrals at an academic medical center between 02/2019-11/2019. The first participant was enrolled on 4/10/2019 and the last participant was enrolled on 11/11/2019.

Participant milestones

Participant milestones
Measure	Women and Men, <2 Years, Individual Interview Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, >2 Years, Individual Interview Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, Lifetime History of ACS, Individual Interview Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Overall Study STARTED	7	9	11
Overall Study COMPLETED	5	8	10
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Women and Men, <2 Years, Individual Interview Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, >2 Years, Individual Interview Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, Lifetime History of ACS, Individual Interview Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Overall Study Lost to Follow-up	1	1	1
Overall Study Did not meet eligibility criteria, withdrawn by PI	1	0	0

Baseline Characteristics

MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women and Men, <2 Years, Individual Interview n=5 Participants Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, >2 Years, Individual Interview n=8 Participants Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, Lifetime History of ACS, Individual Interview n=10 Participants Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Total n=23 Participants Total of all reporting groups
Age, Continuous	62.0 years STANDARD_DEVIATION 12.7 • n=5 Participants	64 years STANDARD_DEVIATION 9.2 • n=7 Participants	63.6 years STANDARD_DEVIATION 6.0 • n=5 Participants	63.4 years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	20 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
PHQ-9 (Patient Health Questionnaire-9) Screen Score	12.2 units on a scale STANDARD_DEVIATION 3 • n=5 Participants	12.3 units on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	1.2 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	7.4 units on a scale STANDARD_DEVIATION 4.9 • n=4 Participants

PRIMARY outcome

Timeframe: one 30-90-minute session

Population: We explored the different types of changes patients might experience after ACS. We analyzed the data to identify the common themes regarding changes after ACS. We report the identified themes and the number of participants who expressed each theme.

This portion of the individual interview will focus on exploring changes experienced after an ACS, such as psychosocial changes and health behavior changes. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.

Outcome measures

Outcome measures
Measure	Women and Men, <2 Years, Individual Interview n=5 Participants Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, >2 Years, Individual Interview n=8 Participants Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, Lifetime History of ACS, Individual Interview n=10 Participants Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Number of Participants Reporting Changes After ACS Positive health behavior changes	3 participants	3 participants	10 participants
Number of Participants Reporting Changes After ACS Social problems	3 participants	2 participants	4 participants
Number of Participants Reporting Changes After ACS Adaptive perspectives	1 participants	0 participants	5 participants
Number of Participants Reporting Changes After ACS Emotional improvements	0 participants	1 participants	1 participants
Number of Participants Reporting Changes After ACS Social improvements	1 participants	0 participants	5 participants
Number of Participants Reporting Changes After ACS Activity limitations	5 participants	7 participants	4 participants
Number of Participants Reporting Changes After ACS Negative physical symptoms	5 participants	8 participants	6 participants
Number of Participants Reporting Changes After ACS Emotional problems	3 participants	8 participants	6 participants
Number of Participants Reporting Changes After ACS Health behavior challenges	2 participants	5 participants	0 participants

PRIMARY outcome

Timeframe: one 30-90-minute session

Population: We explored patients' willingness to participate in a group mindfulness program after ACS. We analyzed the data to identify the common themes. We report the identified themes and the number of participants who expressed each theme.

This portion of the individual interview will focus on exploring patients' perspectives toward an MBCT treatment approach. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.

Outcome measures

Outcome measures
Measure	Women and Men, <2 Years, Individual Interview n=5 Participants Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, >2 Years, Individual Interview n=8 Participants Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, Lifetime History of ACS, Individual Interview n=10 Participants Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Number of Participants With Perspectives on MBCT Willing to get help	3 participants	8 participants	8 participants
Number of Participants With Perspectives on MBCT Willing to participate in a group program	3 participants	6 participants	8 participants
Number of Participants With Perspectives on MBCT Positive reaction to mindfulness	4 participants	7 participants	7 participants

PRIMARY outcome

Timeframe: one 30-90-minute session

Population: We explored patients' perspectives toward using videoconferencing for a treatment program. We analyzed the data to identify the common themes regarding videoconferencing. We report the identified themes and the number of participants who expressed each theme.

This portion of the individual interview will focus on exploring perspectives regarding videoconferencing intervention delivery. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. Identified themes are reported, and the criteria used to determine the outcome measure is the number of participants upon interview who reported expressed each theme.

Outcome measures

Outcome measures
Measure	Women and Men, <2 Years, Individual Interview n=5 Participants Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, >2 Years, Individual Interview n=8 Participants Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Women and Men, Lifetime History of ACS, Individual Interview n=10 Participants Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Individual Interview: Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Number of Participants With Perspectives on Videoconferencing Technology limitations	2 participants	5 participants	2 participants
Number of Participants With Perspectives on Videoconferencing Willing to try videoconferencing	3 participants	7 participants	8 participants
Number of Participants With Perspectives on Videoconferencing Logistical benefits	5 participants	5 participants	7 participants
Number of Participants With Perspectives on Videoconferencing Social benefits	2 participants	1 participants	1 participants
Number of Participants With Perspectives on Videoconferencing Social limitations	2 participants	1 participants	4 participants

PRIMARY outcome

Timeframe: one 30-90-minute session

Population: We explored the patients' perspectives on completing a remote dried blood spot procedure. We analyzed the data to identify the common themes regarding this procedure. We report the identified themes and the number of participants who expressed each theme.

This portion of the individual interview will focus on exploring ACS patients who had perspectives on participating in a remote dried blood spot procedure. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The criteria used to determine the outcome measure is the number of participants upon interview who reported any type of perspective on participating in a remote dried blood spot procedure (self-collection of dried blood spot via finger-prick). Please note that the number of perspectives reported for each theme can exceed the number of people per group because each participant reported multiple perspectives (e.g., both pros and cons of videoconferencing).