Cardiovascular DiseasesNCT04799899
MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT
A study testing Adapted MBCT and Cardiac Health Enhancement in people with Cardiovascular Diseases and Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Acute Coronary Syndrome, Depression
- What is being tested?
- Adapted MBCT and Cardiac Health Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2021to 28 Jan 2023
- 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 80 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 greater than or equal to 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 less than or equal to 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: A Pilot RCT
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.
Read the detailed description
The current study will employ an open pilot RCT with a time-and-attention-matched health control group to determine the feasibility and acceptability of a virtual, MBCT intervention for ACS patients. The investigators plan to enroll approximately N=50 participants (approx. 3 MBCT groups and approx. 3 health enhancement control groups with approximately 6-7 participants per group; accounting for 20% attrition). Participants will be randomized to a MBCT or a time- and attention-matched health enhancement control in a 1:1 design using a random number generator. Participants will then be stratified by antidepressant medication use. 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. The health enhancement control group will follow the same structure of the MBCT intervention (e.g., 8 virtually-delivered MBCT sessions, approximately 1.5 hours each) and will educate participants on depression and cardiac health (e.g., relationship between depression and cardiac health, cardiac risk factors, cardiac health behaviors, finding resources for mental health care). 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 30-60 minutes).
Participants will be recruited through EPIC, 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 informed consent with study staff prior to enrollment.
Participants will be enrolled in either one of three MBCT intervention cohorts (approx.) or one of three health enhancement control cohorts (approx.). Participants in all of these groups will be expected to participate in 8-weekly, 1.5-hour virtual sessions. Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice. Participants in the health enhancement control group will be expected to review educational videos or readings between sessions. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will delivered the intervention to the MBCT intervention group. A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group. Both the MBCT intervention and health enhancement control groups will be delivered via Zoom, 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, for the MBCT-intervention group, home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Exploratory outcomes are changes in emotional and biological variables. Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations.
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome, Depression
- Being tested
- Adapted MBCT, Cardiac Health Enhancement
- Keywords
- Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted MBCTBehavioural
The adapted 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.
Cardiac Health EnhancementBehavioural
The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
| Study group | Role | What they receive |
|---|---|---|
| Virtual MBCT Intervention | Experimental | Participants will participate in 8 weekly virtual group sessions of MBCT. 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 30-60 minutes). Receives: Behavioral: Adapted MBCT |
| Virtual Health Enhancement Control | Experimental | Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. 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 30-60 minutes). Receives: Behavioral: Cardiac Health Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility: Percent of Participants Screened Eligible
Feasibility outcomes for recruitment will include: >70% meet screening criteria
Measured: 6 months
Recruitment Feasibility: Percent of Participants Enrolled
Feasibility outcomes for recruitment will include: >70% of eligible enroll
Measured: 6 months
MBCT Feasibility: Percent of Participants Retained
MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey
Measured: 6 months
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment
MBCT intervention feasibility will include: >75% of participants attending 6/8 sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.
Measured: 6 months
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice
MBCT feasibility will include: >75% complete home practice at least 3 days/week. Adherence was defined as completion of home practice long at least 3 days per week.
Measured: 6 months
Control Group Feasibility: Percent of Participants Retained
Control group feasibility will include: >75% of participants retained at post-assessment survey
Measured: 6 months
Control Group Feasibility: Percent of Participants Adherent to Treatment
Control group feasibility will include: >75% of participants attending 6/8 sessions sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.
Measured: 6 months
Control Group Feasibility: Percent of Participants Adherent to Home Practice
Control group feasibility will include: >75% complete home practice at least 3 days/week. "Adherent to home practice" is defined as participants completing home practice at least 3 days per week.
Measured: 6 months
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems
Videoconferencing feasibility will be assessed by: <20% of sessions missed due to technical problems
Measured: 6 months
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline
Blood spot feasibility will be assessed by >75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.
Measured: At Baseline (Month 0)
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention
Blood spot feasibility will be assessed by >75% of samples submitted at post-intervention
Measured: At Post Intervention (Month 3)
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction
MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by mean score greater than 7.5
Measured: At post intervention (Month 3)
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills
MBCT and acceptability will be assessed by 75% plan to use the skills
Measured: 6 months
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program
MBCT and acceptability will be assessed by >75% of participants reporting that they would recommend the program to others
Measured: 6 months
Control Group Acceptability: Ratings of Intervention Satisfaction
Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by an overall mean score greater than 7.5.
Measured: 6 months
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills
Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
Measured: 6 months
Control Group Acceptability: Percent of Participants Who Would Recommend the Program
Control group acceptability will be assessed by >75% of participants reporting that they would recommend the program to others
Measured: 6 months
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M>7.5)
Measured: 6 months
Blood Spot Acceptability: Blood Spot Collection Ease
Blood spot acceptability will be assessed by ratings of ease of data collection (1=not at all, 10=extremely). Satisfaction will be measured by an overall mean score greater than 7.5.
Measured: 6 months
Blood Spot Acceptability: Blood Spot Collection Comfort
Blood spot acceptability will be assessed by ratings of ease of level of pain (1=very much pain, 10=very little pain; M>8.0). Acceptability will be measured by an overall mean score greater than 8.0.
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 posted16 Mar 2021
- Study start22 Apr 2021
- Primary completion5 Oct 2022
- Study completion28 Jan 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04799899
- Sponsor's protocol ID
- 2021P000544
- Status last verified
- Jan 2025
- First submitted
- 12 Mar 2021
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.
PubMed 34910821
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. 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: A Pilot RCT
- ClinicalTrials.gov ID
- NCT04799899
- Acronym / sponsor ID
- 2021P000544
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome, Depression
- Keywords
- Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.
Detailed description
The current study will employ an open pilot RCT with a time-and-attention-matched health control group to determine the feasibility and acceptability of a virtual, MBCT intervention for ACS patients. The investigators plan to enroll approximately N=50 participants (approx. 3 MBCT groups and approx. 3 health enhancement control groups with approximately 6-7 participants per group; accounting for 20% attrition). Participants will be randomized to a MBCT or a time- and attention-matched health enhancement control in a 1:1 design using a random number generator. Participants will then be stratified by antidepressant medication use. 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. The health enhancement control group will follow the same structure of the MBCT intervention (e.g., 8 virtually-delivered MBCT sessions, approximately 1.5 hours each) and will educate participants on depression and cardiac health (e.g., relationship between depression and cardiac health, cardiac risk factors, cardiac health behaviors, finding resources for mental health care). 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 30-60 minutes).
Participants will be recruited through EPIC, 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 informed consent with study staff prior to enrollment.
Participants will be enrolled in either one of three MBCT intervention cohorts (approx.) or one of three health enhancement control cohorts (approx.). Participants in all of these groups will be expected to participate in 8-weekly, 1.5-hour virtual sessions. Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice. Participants in the health enhancement control group will be expected to review educational videos or readings between sessions. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will delivered the intervention to the MBCT intervention group. A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group. Both the MBCT intervention and health enhancement control groups will be delivered via Zoom, 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, for the MBCT-intervention group, home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Exploratory outcomes are changes in emotional and biological variables. Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual MBCT Intervention | Experimental | Behavioral: Adapted MBCTParticipants will participate in 8 weekly virtual group sessions of MBCT. 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 30-60 minutes). |
| Virtual Health Enhancement Control | Experimental | Behavioral: Cardiac Health EnhancementParticipants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. 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 30-60 minutes). |
Who may qualify
- Ages
- 35 to 80 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 greater than or equal to 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 less than or equal to 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 |
|---|---|---|
| Adapted MBCTThe adapted 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. | Behavioural | Virtual MBCT Intervention |
| Cardiac Health EnhancementThe cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health. | Behavioural | Virtual Health Enhancement Control |
Primary outcome
Recruitment Feasibility: Percent of Participants Screened Eligible
Time frame: 6 months
Feasibility outcomes for recruitment will include: >70% meet screening criteria
Recruitment Feasibility: Percent of Participants Enrolled
Time frame: 6 months
Feasibility outcomes for recruitment will include: >70% of eligible enroll
MBCT Feasibility: Percent of Participants Retained
Time frame: 6 months
MBCT intervention feasibility will include: >75% of participants retained at post-assessment survey
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment
Time frame: 6 months
MBCT intervention feasibility will include: >75% of participants attending 6/8 sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice
Time frame: 6 months
MBCT feasibility will include: >75% complete home practice at least 3 days/week. Adherence was defined as completion of home practice long at least 3 days per week.
Control Group Feasibility: Percent of Participants Retained
Time frame: 6 months
Control group feasibility will include: >75% of participants retained at post-assessment survey
Control Group Feasibility: Percent of Participants Adherent to Treatment
Time frame: 6 months
Control group feasibility will include: >75% of participants attending 6/8 sessions sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.
Control Group Feasibility: Percent of Participants Adherent to Home Practice
Time frame: 6 months
Control group feasibility will include: >75% complete home practice at least 3 days/week. "Adherent to home practice" is defined as participants completing home practice at least 3 days per week.
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems
Time frame: 6 months
Videoconferencing feasibility will be assessed by: <20% of sessions missed due to technical problems
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline
Time frame: At Baseline (Month 0)
Blood spot feasibility will be assessed by >75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention
Time frame: At Post Intervention (Month 3)
Blood spot feasibility will be assessed by >75% of samples submitted at post-intervention
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction
Time frame: At post intervention (Month 3)
MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by mean score greater than 7.5
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills
Time frame: 6 months
MBCT and acceptability will be assessed by 75% plan to use the skills
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program
Time frame: 6 months
MBCT and acceptability will be assessed by >75% of participants reporting that they would recommend the program to others
Control Group Acceptability: Ratings of Intervention Satisfaction
Time frame: 6 months
Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by an overall mean score greater than 7.5.
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills
Time frame: 6 months
Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
Control Group Acceptability: Percent of Participants Who Would Recommend the Program
Time frame: 6 months
Control group acceptability will be assessed by >75% of participants reporting that they would recommend the program to others
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
Time frame: 6 months
Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M>7.5)
Blood Spot Acceptability: Blood Spot Collection Ease
Time frame: 6 months
Blood spot acceptability will be assessed by ratings of ease of data collection (1=not at all, 10=extremely). Satisfaction will be measured by an overall mean score greater than 7.5.
Blood Spot Acceptability: Blood Spot Collection Comfort
Time frame: 6 months
Blood spot acceptability will be assessed by ratings of ease of level of pain (1=very much pain, 10=very little pain; M>8.0). Acceptability will be measured by an overall mean score greater than 8.0.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34910821Tully PJ, Ang SY, Lee EJ, Bendig E, Bauereiss N, Bengel J, Baumeister H. Psychological and pharmacological interventions for depression in patients with coronary artery disease. Cochrane Database Syst Rev. 2021 Dec 15;12(12):CD008012. doi: 10.1002/14651858.CD008012.pub4.
- 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 Adapted MBCT and Cardiac Health Enhancement in people with Cardiovascular Diseases and Acute Coronary Syndrome, 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 29 Jan 2025. 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 29 Jan 2025). 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 Screened Eligible (time frame: 6 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04799899, which also lists 1 linked publication.
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 29 Jan 2025.