Trial Outcomes & Findings for MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms (NCT NCT04231097)

Results Overview

Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

6 months

Results posted on

2023-04-24

Participant Flow

Recruitment occurred from April 2020 - September 2020. Patient were recruited from the study hospital using hospital databases, research invitation letters, provider referrals, and flyers. Patients were also recruited in person while hospitalized.

There is one intervention arm (MBCT). We enrolled two MBCT cohorts of 2 and 6 people each, totaling 8 people. Data are reported for all enrolled participants.

Participant milestones

Participant milestones
Measure	Virtual MBCT MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each/week) delivered via group videoconferencing, 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 involved in the intervention 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).
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	60.5 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Hospital patients meeting preliminary eligibility criteria for ACS, who were approached and consented for eligibility screening

Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening

Outcome measures

Outcome measures
Measure	Virtual MBCT n=191 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Recruitment Feasibility: Percent of Participants Who Consent to Screening	150 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Percent of hospital patients who met preliminary and eligibility screening criteria for ACS. The number who were reached by phone for eligibility screening is 150, but 96 did not complete the full screening protocol and were removed from subsequent analyses. Thus, there were 54 screening completers. The screening outcome is the number eligible out of the 54 who agreed to be completely screened.

Feasibility outcomes for recruitment will include: \>70% meet screening criteria

Outcome measures

Outcome measures
Measure	Virtual MBCT n=54 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria	12 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Percent of hospital patients who met eligibility screening criteria and chose to enroll

Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study

Outcome measures

Outcome measures
Measure	Virtual MBCT n=12 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Recruitment Feasibility: Percent of Eligible Patients Who Consent	8 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: percent of ITT participants who attended \>6/8 session among those who enrolled

MBCT feasibility will be measured by: \>75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention ITT analysis	4 Participants
MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention Completer analysis	4 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: \>75% post-intervention assessments completed among treatment completers and ITT Sample

MBCT feasibility will be measured by: \>75% post-intervention assessments completed

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
MBCT Feasibility: Percent of Participants Retained at Post-Intervention ITT analysis	4 Participants
MBCT Feasibility: Percent of Participants Retained at Post-Intervention Completer analysis	4 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: percent of connections dropped throughout the 8 sessions for both groups (16 sessions)

Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session

Outcome measures

Outcome measures
Measure	Virtual MBCT n=16 Number of virtual sessions Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions	1 Number of virtual sessions

PRIMARY outcome

Timeframe: 6 months

Population: percent of participants who submitted samples at baseline

Blood spot feasibility will be assessed by: \>75% of participants submitting samples at baseline

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline ITT Sample	4 Participants
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline Completers	2 Participants

PRIMARY outcome

Timeframe: 6 Month

Population: Blood spot feasibility will be assessed by: \>75% of participants who submitted samples at post-intervention among Completers and ITT sample

Blood spot feasibility will be assessed by: \>75% of participants submitting samples at post-intervention

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention ITT analysis	4 Participants
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention Completer analysis	4 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Blood spot feasibility will be assessed by: \>60% of participants who submitted samples at follow-up among Completers and ITT sample

Blood spot feasibility will be assessed by: \>60% of participants submitting samples at follow-up

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up ITT	4 Participants
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up Completers	4 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: percent of submitted samples with adequate quality for processing

Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.

Outcome measures

Outcome measures
Measure	Virtual MBCT n=12 Samples submitted for processing Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted	9 Samples submitted for processing

PRIMARY outcome

Timeframe: 6 months

Population: Participants who completed at least one intervention session

Ratings of how helpful the MBCT sessions were for improving mood (1 = not at all helpful to 10 = very helpful), with acceptability defined as Mean \>= 7.5

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
MBCT Acceptability: Helpfulness for Mood	6.98 units on a scale Standard Deviation 1.40

PRIMARY outcome

Timeframe: 6 months

Population: Participants who completed at least one intervention session

The average usefulness ratings for session components on a scale of 1 = not at all useful to 10 = very useful, with mean \>= 7.5 being considered acceptable

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
MBCT Acceptability: Usefulness of Session Components	7.61 units on a scale Standard Deviation 1.55

PRIMARY outcome

Timeframe: 6 Months

Population: Average rating for the level of ease of using videoconferencing for intervention sessions throughout the program

Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M \>= 7.5)

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use	8.60 score on a scale Standard Deviation 1.60

PRIMARY outcome

Timeframe: 6 Months

Population: Average rating for video quality of mindfulness videoconference sessions through all groups for participants who attended at least one session

Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M\>7.5)

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)	8.81 score on a scale Standard Deviation 1.42

PRIMARY outcome

Timeframe: 6 Months

Population: Average rating for overall satisfaction of videoconferencing for mindfulness sessions across all groups for participants who attended at least one group

Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M \> 7.5)

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction	9.75 score on a scale Standard Deviation .05

PRIMARY outcome

Timeframe: Average rating for ease of data submission from blood spot collection through out all groups

Population: Blood spot acceptability will be assessed by ratings of ease of blood spot collection

Blood spot acceptability will be assessed by ratings of ease of blood spot collection (1 = not at all, 10 = very easy; M\>7.5)

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Blood Spot Acceptability: Ease of Blood Spot Collection	7.3 score on a scale Standard Deviation 4.9

PRIMARY outcome

Timeframe: 6 Months

Population: Average rating for the level of pain during blood spot collection

Blood spot acceptability will be assessed by ratings of level of pain during blood spot collection, (1=Very much pain, 10=Very little pain; M\>=7.5).

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Blood Spot Acceptability: Discomfort of Blood Spot Collection	9.5 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: 6 months

Population: Participants who completed the post-intervention survey with data available for analysis

This is a 9-item scale that measures depression. The scoring scale ranges from 0, not at all, to 3, nearly every day. The scoring values range from 0-18, where high values represent higher levels of depression and lower values represent lower levels of depression. Changes of \>= 3 points from before to after the intervention represent clinically meaningful change. The outcome is the % of participants who report clinically meaningful change

Outcome measures

Outcome measures
Measure	Virtual MBCT n=8 Participants Two cohorts of MBCT participants with approximately 10 participants per cohort. MBCT intervention for ACS patients: The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 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 involved in the intervention 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).
Patient Health Questionnaire (PHQ-9)	3 Participants

Adverse Events

Virtual MBCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christina Luberto, PhD

Massachusetts General Hospital

Phone: 617-643-9453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place