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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878160
• Other study ID #: 2018P001000
• Secondary ID: 1K23AT009715-01A
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 85 Years

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

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Depression
• Depressive Disorder
• Infarction
• Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI
• STEMI
• Syndrome
• Unstable Angina

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 111 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one 30-90-minute session
Primary	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.	one 30-90-minute session
Primary	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.	one 30-90-minute session
Primary	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).	one 30-90-minute session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session
Secondary	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.	30-90-minute study session

External Links

•   A Multidimensional Approach to Individual Differences in Empathy
•   A SIMPLE PHENYLALANINE METHOD FOR DETECTING PHENYLKETONURIA IN LARGE POPULATIONS OF NEWBORN INFANTS
•   A Systematic Review and Meta-analysis of the Effects of Meditation on Empathy, Compassion, and Prosocial Behaviors
•   Anthropometric correlates of C-reactive protein among indigenous Siberians
•   Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial
•   Cognitive/affective and somatic/affective symptoms of depression in patients with heart disease and their association with cardiovascular prognosis: a meta-analysis
•   Computer use by older adults: A multi-disciplinary review
•   Depression After Heart Attack Why Should I Be Concerned About Depression After a Heart Attack?
•   Executive Summary: Heart Disease and Stroke Statistics-2016 Update
•   Measuring the Immeasurables: Development and Initial Validation of the Self-Other Four Immeasurables (SOFI) Scale Based on Buddhist Teachings on Loving Kindness, Compassion, Joy, and Equanimity
•   Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes?
•   Mindfulness Skills and Emotion Regulation: The Mediating Role of Coping Self-Efficacy
•   Mindfulness Skills and Emotion Regulation: the Mediating Role of Coping Self-Efficacy
•   Mindfulness-Based Cognitive Therapy (MBCT) Teacher Qualification and Certification
•   Mindfulness-Based Cognitive Therapy Associated with Decreases in C - reactive protein in Major Depressive Disorder: A Pilot Study
•   Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale
•   Positive emotion dispositions differentially associated with Big Five personality and attachment style
•   Risk modification after myocardial infarction
•   The mindfulness-based cognitive therapy adherence scale: inter-rater reliability, adherence to protocol and treatment distinctiveness
•   Videoconferencing in psychiatry, a meta-analysis of assessment and treatment