Clinical trial NCT03878160: MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms
Official title: Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Elevated Depression Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Depression
Myocardial Infarction
Unstable Angina
STEMI
NSTEMI - Non-ST Segment Elevation MI
Keywords: Mindfulness
Acute Coronary Syndrome
Videoconferencing
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-03-18
Enrollment: 27
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: Inclusion criteria for depressed sample:

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

Exclusion criteria for depressed sample :

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

Inclusion criteria for non-depressed sample:

1. Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
2. Age 35-85 years
3. Access to high-speed internet

Exclusion criteria for non-depressed sample:

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

Primary outcomes:
measure: Number of Participants Reporting Changes After ACS
timeFrame: one 30-90-minute session
measure: Number of Participants With Perspectives on MBCT
timeFrame: one 30-90-minute session
measure: Number of Participants With Perspectives on Videoconferencing
timeFrame: one 30-90-minute session
measure: Number of Participants With Perspectives on Blood Spot Data Collection
timeFrame: one 30-90-minute session
Secondary outcomes:
measure: Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15)
timeFrame: 30-90-minute study session
measure: Perceived Stress Scale-4 (PSS-4)
timeFrame: 30-90-minute study session
measure: Positive Affect Negative Affect Schedule (PANAS)
timeFrame: 30-90-minute study session
measure: Rumination Response Scale (RRS)
timeFrame: 30-90-minute study session
measure: Self-Other Four Immeasurables (SOFI) Scale
timeFrame: 30-90-minute study session
measure: Interpersonal Reactivity Index (IRI)
timeFrame: 30-90-minute study session
measure: Medical Outcomes Study - Specific Adherence Scale (MOS- SAS)
timeFrame: 30-90-minute study session
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 30-90-minute study session
measure: Short-Form-12 (SF-12)
timeFrame: 30-90-minute study session
measure: Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF)
timeFrame: 30-90-minute study session
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christina M Luberto, PhD
role: PRINCIPAL_INVESTIGATOR
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