Acute Coronary Syndrome, Depression, Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI, Unstable Angina
Conditions
Keywords
Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
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.
Interventions
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.
Sponsors
Study design
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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via the MGH Patient Hospital Data Registry, and provider referrals at an academic medical center between 02/2019-11/2019. The first participant was enrolled on 4/10/2019 and the last participant was enrolled on 11/11/2019.
Participants by arm
| Arm | Count |
|---|---|
| Women and Men, <2 Years, Individual Interview Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.
Individual Interview: 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. | 5 |
| Women and Men, >2 Years, Individual Interview Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.
Individual Interview: 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. | 8 |
| Women and Men, Lifetime History of ACS, 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.
Individual Interview: 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. | 10 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not meet eligibility criteria, withdrawn by PI | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Women and Men, <2 Years, Individual Interview | Women and Men, >2 Years, Individual Interview | Women and Men, Lifetime History of ACS, Individual Interview | Total |
|---|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 12.7 | 64 years STANDARD_DEVIATION 9.2 | 63.6 years STANDARD_DEVIATION 6 | 63.4 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 8 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| PHQ-9 (Patient Health Questionnaire-9) Screen Score | 12.2 units on a scale STANDARD_DEVIATION 3 | 12.3 units on a scale STANDARD_DEVIATION 2.4 | 1.2 units on a scale STANDARD_DEVIATION 1.3 | 7.4 units on a scale STANDARD_DEVIATION 4.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
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.
Time frame: one 30-90-minute session
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Social improvements | 1 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Health behavior challenges | 2 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Negative physical symptoms | 5 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Activity limitations | 5 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Positive health behavior changes | 3 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Social problems | 3 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Emotional improvements | 0 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Adaptive perspectives | 1 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Emotional problems | 3 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Activity limitations | 7 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Positive health behavior changes | 3 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Adaptive perspectives | 0 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Emotional improvements | 1 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Social improvements | 0 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Negative physical symptoms | 8 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Emotional problems | 8 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Social problems | 2 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants Reporting Changes After ACS | Health behavior challenges | 5 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Emotional improvements | 1 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Positive health behavior changes | 10 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Emotional problems | 6 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Adaptive perspectives | 5 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Health behavior challenges | 0 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Activity limitations | 4 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Social improvements | 5 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Social problems | 4 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants Reporting Changes After ACS | Negative physical symptoms | 6 participants |
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).
Time frame: one 30-90-minute session
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Would need training | 2 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Willing to complete DBS | 5 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Would want more information about the rationale | 5 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Would need training | 5 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Willing to complete DBS | 7 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Would want more information about the rationale | 4 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Willing to complete DBS | 8 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Would want more information about the rationale | 6 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Blood Spot Data Collection | Would need training | 2 participants |
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.
Time frame: one 30-90-minute session
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on MBCT | Willing to participate in a group program | 3 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on MBCT | Willing to get help | 3 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on MBCT | Positive reaction to mindfulness | 4 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on MBCT | Willing to participate in a group program | 6 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on MBCT | Willing to get help | 8 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on MBCT | Positive reaction to mindfulness | 7 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on MBCT | Willing to get help | 8 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on MBCT | Positive reaction to mindfulness | 7 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on MBCT | Willing to participate in a group program | 8 participants |
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.
Time frame: one 30-90-minute session
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Willing to try videoconferencing | 3 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Technology limitations | 2 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Social benefits | 2 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Social limitations | 2 participants |
| Women and Men, <2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Logistical benefits | 5 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Technology limitations | 5 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Willing to try videoconferencing | 7 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Logistical benefits | 5 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Social benefits | 1 participants |
| Women and Men, >2 Years, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Social limitations | 1 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Logistical benefits | 7 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Technology limitations | 2 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Willing to try videoconferencing | 8 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Social limitations | 4 participants |
| Women and Men, Lifetime History of ACS, Individual Interview | Number of Participants With Perspectives on Videoconferencing | Social benefits | 1 participants |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Women and Men, <2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Accepting without judgment | 11 units on a scale |
| Women and Men, <2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Acting with awareness | 11 units on a scale |
| Women and Men, <2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Observing | 8 units on a scale |
| Women and Men, <2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Describing | 11 units on a scale |
| Women and Men, <2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Nonreactivity | 11 units on a scale |
| Women and Men, >2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Acting with awareness | 9 units on a scale |
| Women and Men, >2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Observing | 9 units on a scale |
| Women and Men, >2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Describing | 9 units on a scale |
| Women and Men, >2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Accepting without judgment | 8 units on a scale |
| Women and Men, >2 Years, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Nonreactivity | 9.5 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Nonreactivity | 14 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Accepting without judgment | 14 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Observing | 10 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Acting with awareness | 10 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) | Describing | 13 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Interpersonal Reactivity Index (IRI) | 41 units on a scale |
| Women and Men, >2 Years, Individual Interview | Interpersonal Reactivity Index (IRI) | 39 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Interpersonal Reactivity Index (IRI) | 45 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Medical Outcomes Study - Specific Adherence Scale (MOS- SAS) | 11 units on a scale |
| Women and Men, >2 Years, Individual Interview | Medical Outcomes Study - Specific Adherence Scale (MOS- SAS) | 10 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Medical Outcomes Study - Specific Adherence Scale (MOS- SAS) | 13 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Patient Health Questionnaire-9 (PHQ-9) | 10.5 units on a scale |
| Women and Men, >2 Years, Individual Interview | Patient Health Questionnaire-9 (PHQ-9) | 16 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Patient Health Questionnaire-9 (PHQ-9) | 1.5 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF) | 18 units on a scale |
| Women and Men, >2 Years, Individual Interview | Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF) | 12 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF) | 20 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Perceived Stress Scale-4 (PSS-4) | 12 units on a scale |
| Women and Men, >2 Years, Individual Interview | Perceived Stress Scale-4 (PSS-4) | 14 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Perceived Stress Scale-4 (PSS-4) | 6 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Positive Affect Negative Affect Schedule (PANAS) | 22 units on a scale |
| Women and Men, >2 Years, Individual Interview | Positive Affect Negative Affect Schedule (PANAS) | 26 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Positive Affect Negative Affect Schedule (PANAS) | 34 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Rumination Response Scale (RRS) | 41 units on a scale |
| Women and Men, >2 Years, Individual Interview | Rumination Response Scale (RRS) | 51.5 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Rumination Response Scale (RRS) | 31 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Self-Other Four Immeasurables (SOFI) Scale | 15 units on a scale |
| Women and Men, >2 Years, Individual Interview | Self-Other Four Immeasurables (SOFI) Scale | 12.5 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Self-Other Four Immeasurables (SOFI) Scale | 16 units on a scale |
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.
Time frame: 30-90-minute study session
Population: Participants were patients with a lifetime history of acute coronary syndrome (e.g., myocardial infarction, unstable angina).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Women and Men, <2 Years, Individual Interview | Short-Form-12 (SF-12) | 26 units on a scale |
| Women and Men, >2 Years, Individual Interview | Short-Form-12 (SF-12) | 22 units on a scale |
| Women and Men, Lifetime History of ACS, Individual Interview | Short-Form-12 (SF-12) | 40 units on a scale |