Acute Coronary Syndrome, Depression, Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI, Unstable Angina
Conditions
Keywords
Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
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 N=20 patients (2 cohorts of 10 participants/per cohort, accounting for 20% anticipated lost to follow-up). 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 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 hospital's clinical data registry, advertisements (e.g., 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, 1.5-hour virtual sessions, in conjunction with approximately 30 minutes of at-home daily practice. A licensed mental health provider (e.g., 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.
Interventions
OTHERMBCT 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).
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Approximately N=20 patients (2 cohorts of 10 participants/per cohort, accounting for 20% anticipated lost to follow-up). Assignment to each cohort will be based on timing and/or participant scheduling preferences. Intervention cohort groups will be run either concurrently or sequentially, depending on the enrollment frequency of participants.
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Lifetime ACS per medical record and/or patient confirmation 2. Current elevated depression symptoms (PHQ-9\>5) 3. Age 35-85 years 4. Access to high-speed internet
Exclusion criteria
1. Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review) 2. Non-English-speaking 3. Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen \< 4 4. Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Spot Acceptability: Discomfort of Blood Spot Collection | 6 Months | 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). |
| Recruitment Feasibility: Percent of Participants Who Consent to Screening | 6 months | Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening |
| Recruitment Feasibility: Percent of Participants Meeting Screening Criteria | 6 months | Feasibility outcomes for recruitment will include: \>70% meet screening criteria |
| Recruitment Feasibility: Percent of Eligible Patients Who Consent | 6 Months | Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study |
| MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention | 6 Months | MBCT feasibility will be measured by: \>75% session attendance (i.e., percent who attend at least 6/8 intervention sessions) |
| MBCT Feasibility: Percent of Participants Retained at Post-Intervention | 3 Months | MBCT feasibility will be measured by: \>75% post-intervention assessments completed |
| Videoconferencing Feasibility: Percent of Connections Dropped During Sessions | 6 Months | Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session |
| Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline | 6 months | Blood spot feasibility will be assessed by: \>75% of participants submitting samples at baseline |
| Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention | 6 Month | Blood spot feasibility will be assessed by: \>75% of participants submitting samples at post-intervention |
| Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up | 6 Months | Blood spot feasibility will be assessed by: \>60% of participants submitting samples at follow-up |
| Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted | 6 Months | Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing. |
| MBCT Acceptability: Helpfulness for Mood | 6 months | 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 |
| MBCT Acceptability: Usefulness of Session Components | 6 months | 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 |
| Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use | 6 Months | Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M \>= 7.5) |
| Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys) | 6 Months | Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M\>7.5) |
| Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | 6 Months | Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M \> 7.5) |
| Blood Spot Acceptability: Ease of Blood Spot Collection | Average rating for ease of data submission from blood spot collection through out all groups | Blood spot acceptability will be assessed by ratings of ease of blood spot collection (1 = not at all, 10 = very easy; M\>7.5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | 6 months | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Virtual MBCT 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). | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Virtual MBCT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 60.5 years STANDARD_DEVIATION 14.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Blood Spot Acceptability: Discomfort of 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).
Time frame: 6 Months
Population: Average rating for the level of pain during blood spot collection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | Blood Spot Acceptability: Discomfort of Blood Spot Collection | 9.5 score on a scale | Standard Deviation 0.58 |
Primary
Blood Spot Acceptability: 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)
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | Blood Spot Acceptability: Ease of Blood Spot Collection | 7.3 score on a scale | Standard Deviation 4.9 |
Primary
Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted
Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.
Time frame: 6 Months
Population: percent of submitted samples with adequate quality for processing
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Virtual MBCT | Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted | 9 Samples submitted for processing |
Primary
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention
Blood spot feasibility will be assessed by: \>75% of participants submitting samples at post-intervention
Time frame: 6 Month
Population: Blood spot feasibility will be assessed by: \>75% of participants who submitted samples at post-intervention among Completers and ITT sample
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual MBCT | Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention | ITT analysis | 4 Participants |
| Virtual MBCT | Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention | Completer analysis | 4 Participants |
Primary
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline
Blood spot feasibility will be assessed by: \>75% of participants submitting samples at baseline
Time frame: 6 months
Population: percent of participants who submitted samples at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual MBCT | Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline | ITT Sample | 4 Participants |
| Virtual MBCT | Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline | Completers | 2 Participants |
Primary
Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up
Blood spot feasibility will be assessed by: \>60% of participants submitting samples at follow-up
Time frame: 6 Months
Population: Blood spot feasibility will be assessed by: \>60% of participants who submitted samples at follow-up among Completers and ITT sample
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual MBCT | Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up | ITT | 4 Participants |
| Virtual MBCT | Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up | Completers | 4 Participants |
Primary
MBCT Acceptability: Helpfulness for Mood
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
Time frame: 6 months
Population: Participants who completed at least one intervention session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | MBCT Acceptability: Helpfulness for Mood | 6.98 units on a scale | Standard Deviation 1.4 |
Primary
MBCT Acceptability: Usefulness of Session Components
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
Time frame: 6 months
Population: Participants who completed at least one intervention session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | MBCT Acceptability: Usefulness of Session Components | 7.61 units on a scale | Standard Deviation 1.55 |
Primary
MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention
MBCT feasibility will be measured by: \>75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)
Time frame: 6 Months
Population: percent of ITT participants who attended \>6/8 session among those who enrolled
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual MBCT | MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention | ITT analysis | 4 Participants |
| Virtual MBCT | MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention | Completer analysis | 4 Participants |
Primary
MBCT Feasibility: Percent of Participants Retained at Post-Intervention
MBCT feasibility will be measured by: \>75% post-intervention assessments completed
Time frame: 3 Months
Population: \>75% post-intervention assessments completed among treatment completers and ITT Sample
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Virtual MBCT | MBCT Feasibility: Percent of Participants Retained at Post-Intervention | ITT analysis | 4 Participants |
| Virtual MBCT | MBCT Feasibility: Percent of Participants Retained at Post-Intervention | Completer analysis | 4 Participants |
Primary
Recruitment Feasibility: Percent of Eligible Patients Who Consent
Feasibility outcomes for recruitment will include: \>70% of eligible consent to the study
Time frame: 6 Months
Population: Percent of hospital patients who met eligibility screening criteria and chose to enroll
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual MBCT | Recruitment Feasibility: Percent of Eligible Patients Who Consent | 8 Participants |
Primary
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual MBCT | Recruitment Feasibility: Percent of Participants Meeting Screening Criteria | 12 Participants |
Primary
Recruitment Feasibility: Percent of Participants Who Consent to Screening
Feasibility outcomes for recruitment will include: \>70% of patients reached consent to screening
Time frame: 6 months
Population: Hospital patients meeting preliminary eligibility criteria for ACS, who were approached and consented for eligibility screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual MBCT | Recruitment Feasibility: Percent of Participants Who Consent to Screening | 150 Participants |
Primary
Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use
Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M \>= 7.5)
Time frame: 6 Months
Population: Average rating for the level of ease of using videoconferencing for intervention sessions throughout the program
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use | 8.60 score on a scale | Standard Deviation 1.6 |
Primary
Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)
Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M\>7.5)
Time frame: 6 Months
Population: Average rating for video quality of mindfulness videoconference sessions through all groups for participants who attended at least one session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys) | 8.81 score on a scale | Standard Deviation 1.42 |
Primary
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M \> 7.5)
Time frame: 6 Months
Population: Average rating for overall satisfaction of videoconferencing for mindfulness sessions across all groups for participants who attended at least one group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual MBCT | Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | 9.75 score on a scale | Standard Deviation 0.05 |
Primary
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
Videoconferencing feasibility will be assessed by: \< 20% of connections dropped during session
Time frame: 6 Months
Population: percent of connections dropped throughout the 8 sessions for both groups (16 sessions)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Virtual MBCT | Videoconferencing Feasibility: Percent of Connections Dropped During Sessions | 1 Number of virtual sessions |
Secondary
Patient Health Questionnaire (PHQ-9)
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
Time frame: 6 months
Population: Participants who completed the post-intervention survey with data available for analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Virtual MBCT | Patient Health Questionnaire (PHQ-9) | 3 Participants |