Acute Coronary SyndromeNCT04231097
MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms
A study testing MBCT intervention for ACS patients in people with Acute Coronary Syndrome and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome, Depression, Myocardial Infarction
- What is being tested?
- MBCT intervention for ACS patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lifetime ACS per medical record and/or patient confirmation
- Current elevated depression symptoms (PHQ-9>5)
- Age 35-85 years
- Access to high-speed internet
Who cannot join
- Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
- Non-English-speaking
- Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen < 4
- Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mongan Institute: Health Policy Research Center
Boston, Massachusetts, 02114
About this study
Official title: Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Depression, Myocardial Infarction, Unstable Angina, STEMI, NSTEMI - Non-ST Segment Elevation MI
- Being tested
- MBCT intervention for ACS patients
- Keywords
- Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
- Medical subject headings
- Acute Coronary Syndrome, Depression, Myocardial Infarction, Angina, Unstable, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT intervention for ACS patientsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Virtual MBCT | Experimental | Two cohorts of MBCT participants with approximately 10 participants per cohort. Receives: Other: MBCT intervention for ACS patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility: Percent of Participants Who Consent to Screening
Feasibility outcomes for recruitment will include: >70% of patients reached consent to screening
Measured: 6 months
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
Feasibility outcomes for recruitment will include: >70% meet screening criteria
Measured: 6 months
Recruitment Feasibility: Percent of Eligible Patients Who Consent
Feasibility outcomes for recruitment will include: >70% of eligible consent to the study
Measured: 6 Months
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)
Measured: 6 Months
MBCT Feasibility: Percent of Participants Retained at Post-Intervention
MBCT feasibility will be measured by: >75% post-intervention assessments completed
Measured: 3 Months
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
Videoconferencing feasibility will be assessed by: < 20% of connections dropped during session
Measured: 6 Months
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
Measured: 6 months
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
Measured: 6 Month
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
Measured: 6 Months
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.
Measured: 6 Months
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
Measured: 6 months
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
Measured: 6 months
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)
Measured: 6 Months
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)
Measured: 6 Months
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)
Measured: 6 Months
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)
Measured: Average rating for ease of data submission from blood spot collection through out all groups
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).
Measured: 6 Months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start24 Apr 2020
- Primary completion25 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Luberto, Massachusetts General Hospital
- Investigators
- Christina Luberto, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231097
- Sponsor's protocol ID
- 2020P000045
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2020
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04231097
- Acronym / sponsor ID
- 2020P000045
- Conditions
- Acute Coronary Syndrome, Depression, Myocardial Infarction, Unstable Angina, STEMI, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 24 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual MBCT | Experimental | Other: MBCT intervention for ACS patientsTwo cohorts of MBCT participants with approximately 10 participants per cohort. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lifetime ACS per medical record and/or patient confirmation
- Current elevated depression symptoms (PHQ-9>5)
- Age 35-85 years
- Access to high-speed internet
Key exclusion criteria (4 listed)
- Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
- Non-English-speaking
- Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen < 4
- Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT intervention for ACS patientsThe 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). | Other | Virtual MBCT |
Primary outcome
Recruitment Feasibility: Percent of Participants Who Consent to Screening
Time frame: 6 months
Feasibility outcomes for recruitment will include: >70% of patients reached consent to screening
Recruitment Feasibility: Percent of Participants Meeting Screening Criteria
Time frame: 6 months
Feasibility outcomes for recruitment will include: >70% meet screening criteria
Recruitment Feasibility: Percent of Eligible Patients Who Consent
Time frame: 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
Time frame: 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
Time frame: 3 Months
MBCT feasibility will be measured by: >75% post-intervention assessments completed
Videoconferencing Feasibility: Percent of Connections Dropped During Sessions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 Months
Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.
MBCT Acceptability: Helpfulness for Mood
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Blood Spot Acceptability: Discomfort of Blood Spot Collection
Time frame: 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).
1 secondary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Luberto, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT intervention for ACS patients in people with Acute Coronary Syndrome and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility: Percent of Participants Who Consent to Screening (time frame: 6 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.