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

Not Applicable

Completed

Conditions: Acute Coronary Syndrome
STEMI
NSTEMI - Non-ST Segment Elevation MI
Depression
Myocardial Infarction
Unstable Angina

Interventions: Other: Individual Interview

Registration Number: NCT03878160

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women and Men, >2 years, Individual Interview	Individual Interview	Individual 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	Individual Interview	Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.
Women and Men, <2 years, Individual Interview	Individual Interview	Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Perspectives on Videoconferencing	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 MBCT	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 Blood Spot Data Collection	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).
Number of Participants Reporting Changes After ACS	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.

Secondary Outcome Measures

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