Acute Coronary SyndromeNCT03878160

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

A study testing Individual Interview in people with Acute Coronary Syndrome and Depression, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Acute Coronary Syndrome, Depression, Myocardial Infarction
What is being tested?: Individual Interview
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2018to 1 Feb 2020
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
Current elevated depression symptoms (PHQ-9≥10)
Age 35-85 years
Access to high-speed internet
Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
Age 35-85 years
Access to high-speed internet

Who cannot join

Active suicidal ideation or past-year psychiatric hospitalization
Non-English-speaking
Cognitive impairments preventing informed consent.
Active suicidal ideation or past-year psychiatric hospitalization
Non-English-speaking
Cognitive impairments preventing informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Elevated Depression Symptoms

The objective of this study is to identify Acute Coronary Syndromes (ACS) patients' specific needs and preferences for depression treatment via in-person or virtual individual interviews to (a) guide MBCT adaptation; and identify barriers and facilitators to (b) group videoconferencing delivery, and (c) blood spot data collection to enhance feasibility. Through qualitative measures participants will report specific physical, cognitive, and behavioral symptoms to be targeted in the intervention, discuss barriers and facilitators to participating in a video-conference treatment program and completing blood spot data collection procedures.

Read the detailed description

This is a qualitative research study that will involve individual interviews of ACS patients with elevated depression symptoms (stratified by time since ACS [≤2 years and >2 years post ACS]; N=10 participants per strata) to explore patients' treatment needs and preferences for an adapted MBCT intervention, and barriers and facilitators for future intervention research procedures (i.e., videoconferencing delivery of the intervention and collection of dried blood spots). It will also involve individual interviews of ACS patients without elevated depression symptoms (N=10) to better understand the needs of ACS patients who are interested in treatment but not currently depressed, in order to inform future outreach and treatment development efforts (total N=30). Interviews will be conducted either in person, by phone, or by video conference.

Participants will be recruited in several ways. First, participants will be identified using the MGH Research Patient Data Registry (RPDR). Participants will be pre-screened for eligibility and sent an opt-out letter. Patients will have the option to opt out via phone or email. Patients who do not opt out and meet eligibility requirements will be contacted via phone. Over the phone, patients who express interest in the study will complete an eligibility screen; patients who meet study eligibility criteria will then complete a verbal consent to enroll in the study. Second, patients will be recruited through advertisements (e.g., flyers, brochures) placed throughout inpatient and/or outpatient hospital clinics, community mental health clinics, community businesses (e.g. coffee shops) and social media platforms. The advertisements will ask patients to contact study staff if they are interested in learning more about the study, and the screening procedures will be the same as those described above for RPDR patients. Lastly, patients will be recruited via direct referrals from their providers (e.g., cardiologists, psychiatrists). We will inform providers about the study (e.g., via short presentations at their team meetings) and provide them with advertisement materials to give to their patients. The patients may either contact study staff directly using the information their provider gave them, and/or the provider will contact the study team with the patient's information so that the study team may reach out to the patient. Providers will obtain verbal permission from the patient for the research team to contact them.

Once enrolled, participants will partake in a semi-structured in-person individual interview. Individual interviews will be stratified by time since ACS and depressive symptoms and will explore (a) emotional symptoms; (b) health behavior challenges; (c) specific preferences for the MBCT intervention; and (d) potential barriers and facilitators of group videoconferencing and (e) blood spot data collection. Participants will also complete a survey detailing depression symptoms, trait mindfulness, health behaviors, and other psychological, behavioral, and physical constructs that may potentially be impacted by the MBCT intervention in subsequent trials will be measured. Data collected from the individual interviews will be used to guide MBCT adaptations and research procedures for future clinical trials.

Conditions: Acute Coronary Syndrome, Depression, Myocardial Infarction, Unstable Angina, STEMI, NSTEMI - Non-ST Segment Elevation MI
Being tested: Individual Interview
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.

Individual InterviewOther
Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.

Study groups in NCT03878160
Study group	Role	What they receive
Women and Men, <2 years, Individual Interview	Other	Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms. Receives: Other: Individual Interview
Women and Men, >2 years, Individual Interview	Other	Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms. Receives: Other: Individual Interview
Women and Men, Lifetime History of ACS, Individual Interview	Other	Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms. Receives: Other: Individual Interview

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Changes After ACS
This portion of the individual interview will focus on exploring changes experienced after an ACS, such as psychosocial changes and health behavior changes. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.
Measured: one 30-90-minute session
Number of Participants With Perspectives on MBCT
This portion of the individual interview will focus on exploring patients' perspectives toward an MBCT treatment approach. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.
Measured: one 30-90-minute session
Number of Participants With Perspectives on Videoconferencing
This portion of the individual interview will focus on exploring perspectives regarding videoconferencing intervention delivery. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. Identified themes are reported, and the criteria used to determine the outcome measure is the number of participants upon interview who reported expressed each theme.
Measured: one 30-90-minute session
Number of Participants With Perspectives on Blood Spot Data Collection
This portion of the individual interview will focus on exploring ACS patients who had perspectives on participating in a remote dried blood spot procedure. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The criteria used to determine the outcome measure is the number of participants upon interview who reported any type of perspective on participating in a remote dried blood spot procedure (self-collection of dried blood spot via finger-prick). Please note that the number of perspectives reported for each theme can exceed the number of people per group because each participant reported multiple perspectives (e.g., both pros and cons of videoconferencing).
Measured: one 30-90-minute session

Secondary outcomes (10)

Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15)
This is a 15-item measure that measures mindfulness. This scale has five sub-scales: observing, describing, acting with awareness, accepting without judgment, and non-reactivity. The scoring scale ranges from 1, never or very rarely true to 5, very often or always true. Scale values range from 3-15 for each sub-scale, with higher values representing greater levels of individual mindfulness and lower values representing lowers levels of individual mindfulness. There is no total score for the measure; only individual sub-scales are reported. Data collection for this measurement is cross-sectional, and is collected during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Perceived Stress Scale-4 (PSS-4)
This is a 4-item scale that measures stress. The scoring scale ranges from 0,never, to 4, very often. The scale values range from 0-16 with higher values representing higher levels of individual stress and lower values representing lower levels of individual stress. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Positive Affect Negative Affect Schedule (PANAS)
This is a 20-question scale, composed of 2, 10-item scales that measure positive and negative affect. The scoring scale ranges from 1, very slightly or not at all, to 5, extremely. For this study, we will only use the positive affect sub-scale. The scale values for the positive affect sub-scale range from 10-50. Higher values on the positive affect scale represent higher levels of positive affect, whereas, lower values on the negative affect scale represent lower levels of positive affect. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Rumination Response Scale (RRS)
This is a 22-item scale that measures rumination. The scoring scale ranges from 1,almost never, to 4, almost always. The score values range from 22 to 88, where higher values represent higher levels of rumination and lower values represent lower levels of rumination. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Self-Other Four Immeasurables (SOFI) Scale
This is a 16-item scale that measures views toward the self and others. This measure consists of four sub-scales with four items each. The sub-scales measure positive views toward self, negative views toward self, positive views toward others, and negative views toward other. Only the positive-other sub-scale was used. The scoring scale ranges from 1, very slightly or not at all to 5, extremely, with sub-scale scores ranging from 4-20. Higher values represent higher levels of positive feelings toward others, and lower values represent lower levels of positive feelings toward others. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Interpersonal Reactivity Index (IRI)
This is a 14-item scale that measures empathy. The scoring scale ranges from 0, does not describe me well, to 4, describes me very well. The score values range from 0-56, where high values represent higher levels of empathy and lower values represent lower levels of empathy. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Medical Outcomes Study - Specific Adherence Scale (MOS- SAS)
This is a 3-item scale that measures health behaviors. The scoring scale ranges from 1, none of the time, to 6, all of the time. The scoring values range from 3-18, where higher values represent good health behavior and lower values represent poor health behavior. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Patient Health Questionnaire-9 (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. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Short-Form-12 (SF-12)
This is a 12-item scale that measures health-related quality of life. The scoring scale from item 1 ranges from 1, excellent to 5, poor. The scoring scale for items 2 and 3 ranges from 1, limit you a lot to 3, not limit you at all. The scoring scale for questions 5-7 is represented by 1, yes or 2, no. The scoring scale for item 8 ranges from 1, not at all, to 5, extremely. The scoring scale for items 9-11 ranges from 1, all of the time, to 6, none of the time. The scoring scale for item 12 ranges from 1, all of the time to 5, none of the time. The total scoring values range from 12- 47, where higher values represent a higher quality of life and lower values represent a lower quality of life. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session
Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF)
This is a 4-item scale that measures and evaluates physical health. The scoring scale ranges from 5, without any difficulty, to 1, unable to do. The scoring values range from 4-20, where high values represent good physical function and low values represent poor physical function. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Measured: 30-90-minute study session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20181 Feb 2020

First posted18 Mar 2019
Study start1 Jul 2018
Primary completion1 Feb 2020
Study completion1 Feb 2020

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 (111)Papers the sponsor has linked to this study.
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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Approximately 20 individual interviews of ACS patients with elevated depression symptoms stratified by time since ACS (e.g. within the past 2 years or greater than 2 years ago), with 10 participants per strata. There will be approximately 10 individual interviews with ACS patients who are interested in treatment but not currently depressed.
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03878160
Sponsor's protocol ID: 2018P001000
Other IDs: 1K23AT009715-01A1
Status last verified: May 2021
First submitted: 26 Feb 2019
Last updated: 4 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007 Mar;37(3):319-28. doi: 10.1017/S0033291706008944. Epub 2006 Nov 20.
PubMed 17112400
Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
PubMed 22466510
Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992.
PubMed 24493760
Uchino BN. Social support and health: a review of physiological processes potentially underlying links to disease outcomes. J Behav Med. 2006 Aug;29(4):377-87. doi: 10.1007/s10865-006-9056-5. Epub 2006 Jun 7.
PubMed 16758315
Uchino BN, Cacioppo JT, Kiecolt-Glaser JK. The relationship between social support and physiological processes: a review with emphasis on underlying mechanisms and implications for health. Psychol Bull. 1996 May;119(3):488-531. doi: 10.1037/0033-2909.119.3.488.
PubMed 8668748
House JS, Landis KR, Umberson D. Social relationships and health. Science. 1988 Jul 29;241(4865):540-5. doi: 10.1126/science.3399889.
PubMed 3399889
Mohr DC, Burns MN, Schueller SM, Clarke G, Klinkman M. Behavioral intervention technologies: evidence review and recommendations for future research in mental health. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):332-8. doi: 10.1016/j.genhosppsych.2013.03.008. Epub 2013 May 8.
PubMed 23664503
Ayala GX, Elder JP. Qualitative methods to ensure acceptability of behavioral and social interventions to the target population. J Public Health Dent. 2011 Winter;71 Suppl 1(0 1):S69-79. doi: 10.1111/j.1752-7325.2011.00241.x.
PubMed 21656958
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.
PubMed 10987780
Miller G, Chen E, Cole SW. Health psychology: developing biologically plausible models linking the social world and physical health. Annu Rev Psychol. 2009;60:501-24. doi: 10.1146/annurev.psych.60.110707.163551.
PubMed 19035829
Huffman JC, Celano CM, Beach SR, Motiwala SR, Januzzi JL. Depression and cardiac disease: epidemiology, mechanisms, and diagnosis. Cardiovasc Psychiatry Neurol. 2013;2013:695925. doi: 10.1155/2013/695925. Epub 2013 Apr 7.
PubMed 23653854
Miller EM, McDade TW. A highly sensitive immunoassay for interleukin-6 in dried blood spots. Am J Hum Biol. 2012 Nov-Dec;24(6):863-5. doi: 10.1002/ajhb.22324. Epub 2012 Oct 5.
PubMed 23042671
McDade TW, Williams S, Snodgrass JJ. What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research. Demography. 2007 Nov;44(4):899-925. doi: 10.1353/dem.2007.0038.
PubMed 18232218
Skogstrand K, Thorsen P, Norgaard-Pedersen B, Schendel DE, Sorensen LC, Hougaard DM. Simultaneous measurement of 25 inflammatory markers and neurotrophins in neonatal dried blood spots by immunoassay with xMAP technology. Clin Chem. 2005 Oct;51(10):1854-66. doi: 10.1373/clinchem.2005.052241. Epub 2005 Aug 4.
PubMed 16081507
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.
PubMed 24446411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2021. 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 Elevated Depression Symptoms
ClinicalTrials.gov ID: NCT03878160
Acronym / sponsor ID: 2018P001000
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: 27 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 1 Jul 2018 (actual)
Primary completion: 1 Feb 2020 (actual)
Study completion: 1 Feb 2020 (actual)
First posted: 18 Mar 2019 (actual)
Results: Posted 4 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Approximately 20 individual interviews of ACS patients with elevated depression symptoms stratified by time since ACS (e.g. within the past 2 years or greater than 2 years ago), with 10 participants per strata. There will be approximately 10 individual interviews with ACS patients who are interested in treatment but not currently depressed.

Arm	Type	Receives
Women and Men, <2 years, Individual Interview	Other	Other: Individual InterviewIndividual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.
Women and Men, >2 years, Individual Interview	Other	Other: Individual InterviewIndividual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.
Women and Men, Lifetime History of ACS, Individual Interview	Other	Other: Individual InterviewIndividual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.

Who may qualify

Ages: 35 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
Current elevated depression symptoms (PHQ-9≥10)
Age 35-85 years
Access to high-speed internet
Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation

Key exclusion criteria (6 listed)

Active suicidal ideation or past-year psychiatric hospitalization
Non-English-speaking
Cognitive impairments preventing informed consent.
Active suicidal ideation or past-year psychiatric hospitalization
Non-English-speaking

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
Individual InterviewIndividual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.	Other	Women and Men, <2 years, Individual Interview, Women and Men, >2 years, Individual Interview, Women and Men, Lifetime History of ACS, Individual Interview

Primary outcome

Number of Participants Reporting Changes After ACS
Time frame: one 30-90-minute session
This portion of the individual interview will focus on exploring changes experienced after an ACS, such as psychosocial changes and health behavior changes. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.
Number of Participants With Perspectives on MBCT
Time frame: one 30-90-minute session
This portion of the individual interview will focus on exploring patients' perspectives toward an MBCT treatment approach. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The identified themes are reported, and the criteria used to determine the outcome measure is the number of participants who endorsed each theme.
Number of Participants With Perspectives on Videoconferencing
Time frame: one 30-90-minute session
This portion of the individual interview will focus on exploring perspectives regarding videoconferencing intervention delivery. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. Identified themes are reported, and the criteria used to determine the outcome measure is the number of participants upon interview who reported expressed each theme.
Number of Participants With Perspectives on Blood Spot Data Collection
Time frame: one 30-90-minute session
This portion of the individual interview will focus on exploring ACS patients who had perspectives on participating in a remote dried blood spot procedure. Participants were individually interviewed via telephone using a semi-structured interview guide. Three independent coders conducted qualitative thematic analysis and results were analyzed within each group. The criteria used to determine the outcome measure is the number of participants upon interview who reported any type of perspective on participating in a remote dried blood spot procedure (self-collection of dried blood spot via finger-prick). Please note that the number of perspectives reported for each theme can exceed the number of people per group because each participant reported multiple perspectives (e.g., both pros and cons of videoconferencing).

10 secondary outcomes

Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15)
Time frame: 30-90-minute study session
Perceived Stress Scale-4 (PSS-4)
Time frame: 30-90-minute study session
Positive Affect Negative Affect Schedule (PANAS)
Time frame: 30-90-minute study session
Rumination Response Scale (RRS)
Time frame: 30-90-minute study session
Self-Other Four Immeasurables (SOFI) Scale
Time frame: 30-90-minute study session
Interpersonal Reactivity Index (IRI)
Time frame: 30-90-minute study session
Medical Outcomes Study - Specific Adherence Scale (MOS- SAS)
Time frame: 30-90-minute study session
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 30-90-minute study session
Short-Form-12 (SF-12)
Time frame: 30-90-minute study session
Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF)
Time frame: 30-90-minute study session

Results and safety

Results posted to the registry on 4 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Women and Men, <2 Years, Individual Interview	7	5
Women and Men, >2 Years, Individual Interview	9	8
Women and Men, Lifetime History of ACS, Individual Interview	11	10

Primary outcome: Number of Participants Reporting Changes After ACS

Time frame: one 30-90-minute session. Number. Unit: participants

Measure	Women and Men, <2 Years, Individual Interview n = 5	Women and Men, >2 Years, Individual Interview n = 8	Women and Men, Lifetime History of ACS, Individual Interview n = 10
Positive health behavior changes	3	3	10
Adaptive perspectives	1	0	5
Emotional improvements	0	1	1
Social improvements	1	0	5
Activity limitations	5	7	4
Negative physical symptoms	5	8	6
Emotional problems	3	8	6
Social problems	3	2	4

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

Primary outcome: Number of Participants With Perspectives on MBCT

Time frame: one 30-90-minute session. Number. Unit: participants

Measure	Women and Men, <2 Years, Individual Interview n = 5	Women and Men, >2 Years, Individual Interview n = 8	Women and Men, Lifetime History of ACS, Individual Interview n = 10
Willing to get help	3	8	8
Willing to participate in a group program	3	6	8
Positive reaction to mindfulness	4	7	7

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

Primary outcome: Number of Participants With Perspectives on Videoconferencing

Time frame: one 30-90-minute session. Number. Unit: participants

Measure	Women and Men, <2 Years, Individual Interview n = 5	Women and Men, >2 Years, Individual Interview n = 8	Women and Men, Lifetime History of ACS, Individual Interview n = 10
Willing to try videoconferencing	3	7	8
Logistical benefits	5	5	7
Social benefits	2	1	1
Technology limitations	2	5	2
Social limitations	2	1	4

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

Primary outcome: Number of Participants With Perspectives on Blood Spot Data Collection

Time frame: one 30-90-minute session. Number. Unit: participants

Measure	Women and Men, <2 Years, Individual Interview n = 5	Women and Men, >2 Years, Individual Interview n = 8	Women and Men, Lifetime History of ACS, Individual Interview n = 10
Willing to complete DBS	5	7	8
Would need training	2	5	2
Would want more information about the rationale	5	4	6

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

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women and Men, <2 Years, Individual Interview	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Women and Men, >2 Years, Individual Interview	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Women and Men, Lifetime History of ACS, Individual Interview	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17112400Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med. 2007 Mar;37(3):319-28. doi: 10.1017/S0033291706008944. Epub 2006 Nov 20.
Background: PubMed 22466510Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.
Background: PubMed 24493760Kvedar J, Coye MJ, Everett W. Connected health: a review of technologies and strategies to improve patient care with telemedicine and telehealth. Health Aff (Millwood). 2014 Feb;33(2):194-9. doi: 10.1377/hlthaff.2013.0992.
Background: PubMed 16758315Uchino BN. Social support and health: a review of physiological processes potentially underlying links to disease outcomes. J Behav Med. 2006 Aug;29(4):377-87. doi: 10.1007/s10865-006-9056-5. Epub 2006 Jun 7.
Background: PubMed 8668748Uchino BN, Cacioppo JT, Kiecolt-Glaser JK. The relationship between social support and physiological processes: a review with emphasis on underlying mechanisms and implications for health. Psychol Bull. 1996 May;119(3):488-531. doi: 10.1037/0033-2909.119.3.488.
Background: PubMed 3399889House JS, Landis KR, Umberson D. Social relationships and health. Science. 1988 Jul 29;241(4865):540-5. doi: 10.1126/science.3399889.
Background: PubMed 23664503Mohr DC, Burns MN, Schueller SM, Clarke G, Klinkman M. Behavioral intervention technologies: evidence review and recommendations for future research in mental health. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):332-8. doi: 10.1016/j.genhosppsych.2013.03.008. Epub 2013 May 8.
Background: PubMed 21656958Ayala GX, Elder JP. Qualitative methods to ensure acceptability of behavioral and social interventions to the target population. J Public Health Dent. 2011 Winter;71 Suppl 1(0 1):S69-79. doi: 10.1111/j.1752-7325.2011.00241.x.
Background: PubMed 10987780Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.
Background: PubMed 19035829Miller G, Chen E, Cole SW. Health psychology: developing biologically plausible models linking the social world and physical health. Annu Rev Psychol. 2009;60:501-24. doi: 10.1146/annurev.psych.60.110707.163551.
Background: PubMed 23653854Huffman JC, Celano CM, Beach SR, Motiwala SR, Januzzi JL. Depression and cardiac disease: epidemiology, mechanisms, and diagnosis. Cardiovasc Psychiatry Neurol. 2013;2013:695925. doi: 10.1155/2013/695925. Epub 2013 Apr 7.
Background: PubMed 23042671Miller EM, McDade TW. A highly sensitive immunoassay for interleukin-6 in dried blood spots. Am J Hum Biol. 2012 Nov-Dec;24(6):863-5. doi: 10.1002/ajhb.22324. Epub 2012 Oct 5.
Mindfulness-Based Cognitive Therapy Associated with Decreases in C - reactive protein in Major Depressive Disorder: A Pilot StudyLink provided by the sponsor.
A Systematic Review and Meta-analysis of the Effects of Meditation on Empathy, Compassion, and Prosocial BehaviorsLink provided by the sponsor.
Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes?Link provided by the sponsor.
Cognitive/affective and somatic/affective symptoms of depression in patients with heart disease and their association with cardiovascular prognosis: a meta-analysisLink provided by the sponsor.
Videoconferencing in psychiatry, a meta-analysis of assessment and treatmentLink provided by the sponsor.
Mindfulness-Based Cognitive Therapy (MBCT) Teacher Qualification and CertificationLink provided by the sponsor.
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 M 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 Individual Interview 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 7 inclusion and 6 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 4 Jun 2021. 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 4 Jun 2021). 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?

Number of Participants Reporting Changes After ACS (time frame: one 30-90-minute session). The study lists 4 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 NCT03878160, which also lists 111 linked publications.

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 4 Jun 2021.