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

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ClinicalTrials.gov Identifier: NCT03878160
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christina Luberto, 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 focus groups 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Depression Myocardial Infarction Unstable Angina STEMI NSTEMI - Non-ST Segment Elevation MI Other: Focus Group Not Applicable

Detailed Description:
This is a qualitative research study that will involve at least eight in-person focus group of ACS patients (approximately 8 participants per group; total N = approximately 30-40 participants) 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). 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 who 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. Once enrolled, participants will partake in a semi-structured in person focus group. Focus groups will be stratified by gender and time since ACS and 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 will be used to guide MBCT adaptations and research procedures for future clinical trials.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Approximately eight in-person focus groups stratified by gender and time since ACS, with 2 groups for each strata. There will be 2 groups of women who have experienced an ACS within the past 2 years, 2 groups of men who have experienced an ACS within the past 2 years, 2 groups of women who have experienced an ACS greater than 2 years ago and 2 groups of men who have experienced an ACS greater than 2 years ago. Each focus group will have approximately 4-8 participants.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Elevated Depression Symptoms
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Women, <2 years, Groups 1 and 2
2 focus groups for women who have experienced an ACS within the past 2 years.
Other: Focus Group
Focus groups 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. The interview guide will be piloted with 3-4 participants and refinements will be made as needed before conducting the focus groups. Focus groups will be conducted until thematic saturation is reached. Focus groups will be audio-recorded for transcription and data analysis.

Men, <2 years, Groups 3 and 4
2 focus groups for men who have experienced an ACS within the past 2 years.
Other: Focus Group
Focus groups 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. The interview guide will be piloted with 3-4 participants and refinements will be made as needed before conducting the focus groups. Focus groups will be conducted until thematic saturation is reached. Focus groups will be audio-recorded for transcription and data analysis.

Women, >2 years, Groups 5 and 6
2 focus groups for women who have experienced an ACS greater than 2 years ago.
Other: Focus Group
Focus groups 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. The interview guide will be piloted with 3-4 participants and refinements will be made as needed before conducting the focus groups. Focus groups will be conducted until thematic saturation is reached. Focus groups will be audio-recorded for transcription and data analysis.

Men, >2 years, Groups 7 and 8
2 focus groups for men who have experienced an ACS greater than 2 years ago.
Other: Focus Group
Focus groups 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. The interview guide will be piloted with 3-4 participants and refinements will be made as needed before conducting the focus groups. Focus groups will be conducted until thematic saturation is reached. Focus groups will be audio-recorded for transcription and data analysis.




Primary Outcome Measures :
  1. Qualitative focus group on changes following an ACS [ Time Frame: one 90-minute session ]
    This portion of the focus group will focus on exploring changes experienced after an ACS, such as psychosocial changes and health behavior changes. Resulted will be coded and measured using NVIVO.

  2. Qualitative focus group on MBCT treatment preferences [ Time Frame: one 90-minute session ]
    This portion of the focus group will focus on exploring specific preferences for an MBCT intervention.Resulted will be coded and measured using NVIVO.

  3. Qualitative focus group on treatment barriers [ Time Frame: one 90-minute session ]
    This portion of the focus group will focus on exploring potential barriers and facilitators of group videoconferencing.Resulted will be coded and measured using NVIVO.

  4. Qualitative focus group on blood spot data collection [ Time Frame: one 90-minute session ]
    This portion of the focus group will focus on exploring preferences towards blood spot data collection. Resulted will be coded and measured using NVIVO.


Secondary Outcome Measures :
  1. Five Factor Mindfulness Questionnaire- 15 item (FFMQ-15) [ Time Frame: 90-minute Study Visit ]
    This is a 15-item measure that measures mindfulness.This scale has five sub-scales: observing, describing, acting with awareness, non-judging, 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. Data collection for this measurement is cross-sectional, and is collected during one, 90 minute time interval.

  2. Perceived Stress Scale-4 (PSS-4) [ Time Frame: 90-minute Study Visit ]
    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, 90 minute time interval.

  3. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 90-minute Study Visit ]
    This a 36-item scale that measures emotion dysregulation. This measure includes six sub-scales :awareness, clarity, impulsivity, goals, strategies, and acceptance. Clarity has 5 items, awareness has 6 items, impulsivity has 6 items, acceptance has 6 items, goals has 5 items, and strategies has 8 items. The scoring scale ranges from 1, almost never (0-10%), to 5, almost always(91-100%). The scale values range from 36- 180, with higher values representing greater emotion dysregulation and lower scores representing lower emotion dysregulation. Data collection for this measurement is cross-sectional, and is performed during one, 90 minute time interval.

  4. Positive Affect Negative Affect Schedule (PANAS) [ Time Frame: 90-minute Study Visit ]
    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. The scale values range from 10-50 for each 10-item scale. 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 negative affect. Data collection for this measurement is cross-sectional, and is performed during one, 90 minute time interval.

  5. Rumination Response Scale (RRS) [ Time Frame: 90-minute Study Visit ]
    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, 90 minute time interval.

  6. Self-Other Four Immeasurables (SOFI) Scale [ Time Frame: 90-minute Study Visit ]
    This is a 16-item scale that measures loving kindness, compassion, joy and acceptance towards self and others. This scale consists of four sub-scales: positive self, negative self, positive other, and negative other. The scoring scale ranges from 1, very slightly or not at all to 5, extremely, with sub-scale values ranging from 4-16. Higher values associated with the positive self and positive other sub-scales and lower values associated with negative self and negative other sub-scales represent higher levels of positive qualities expressed towards self and other; and lower values associated with the negative self and negative other sub-scales and higher values associated with negative self and negative other sub-scales represent higher levels of negative qualities expressed towards self and other. Data collection for this measurement is cross-sectional, and is performed during one, 90 minute time interval.

  7. Interpersonal Reactivity Index (IRI) [ Time Frame: 90-minute Study Visit ]
    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, 90 minute time interval.

  8. Dispositional Positive Emotions Scale- Compassion (DPES-C) [ Time Frame: 90-minute Study Visit ]
    This is a 5-item scale that measures compassion. The scoring scale ranges from 1,strongly disagree, to 7, strongly agree. The score values range from 5-35 where higher values represent higher levels of compassion and lower values represent lower levels of compassion. Data collection for this measurement is cross-sectional, and is performed during one, 90 minute time interval.

  9. Medical Outcomes Study - Specific Adherence Scale (MOS- SAS) [ Time Frame: 90-minute Study Visit ]
    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, 90 minute time interval.

  10. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 90-minute Study Visit ]
    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, 90 minute time interval.

  11. Short-Form-12 (SF-12) [ Time Frame: 90-minute Study Visit ]
    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, 90 minute time interval.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Lifetime ACS per medical record and patient confirmation
  2. Current elevated depression symptoms (PHQ-9>10)
  3. Age 35-85 years
  4. Access to high-speed internet

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878160


Contacts
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Contact: Christina M Luberto, PhD (617) 724-6300 ext 111-134-146 cluberto@mgh.harvard.edu
Contact: Elyse Park, PhD (617) 724-6836 epark@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christina M Luberto, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christina M Luberto, PhD Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Christina Luberto, Massachusetts General Hospital:
Statistical Analysis Plan  [PDF] February 22, 2019
Study Protocol  [PDF] November 6, 2018


Additional Information:
Mindfulness-Based Cognitive Therapy Associated with Decreases in C - reactive protein in Major Depressive Disorder: A Pilot Study  This link exits the ClinicalTrials.gov site A Systematic Review and Meta-analysis of the Effects of Meditation on Empathy, Compassion, and Prosocial Behaviors  This link exits the ClinicalTrials.gov site Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes?  This link exits the ClinicalTrials.gov site Depression After Heart Attack Why Should I Be Concerned About Depression After a Heart Attack?  This link exits the ClinicalTrials.gov site Cognitive/affective and somatic/affective symptoms of depression in patients with heart disease and their association with cardiovascular prognosis: a meta-analysis  This link exits the ClinicalTrials.gov site Risk modification after myocardial infarction  This link exits the ClinicalTrials.gov site Executive Summary: Heart Disease and Stroke Statistics&#8212;2016 Update  This link exits the ClinicalTrials.gov site Computer use by older adults: A multi-disciplinary review  This link exits the ClinicalTrials.gov site Videoconferencing in psychiatry, a meta-analysis of assessment and treatment  This link exits the ClinicalTrials.gov site Mindfulness Skills and Emotion Regulation: The Mediating Role of Coping Self-Efficacy  This link exits the ClinicalTrials.gov site Mindfulness Skills and Emotion Regulation: the Mediating Role of Coping Self-Efficacy  This link exits the ClinicalTrials.gov site Mindfulness-Based Cognitive Therapy (MBCT) Teacher Qualification and Certification  This link exits the ClinicalTrials.gov site The mindfulness&#8208;based cognitive therapy adherence scale: inter&#8208;rater reliability, adherence to protocol and treatment distinctiveness  This link exits the ClinicalTrials.gov site A SIMPLE PHENYLALANINE METHOD FOR DETECTING PHENYLKETONURIA IN LARGE POPULATIONS OF NEWBORN INFANTS  This link exits the ClinicalTrials.gov site Anthropometric correlates of C-reactive protein among indigenous Siberians  This link exits the ClinicalTrials.gov site Breathing retraining for African-American adolescents with asthma: a pilot study of a school-based randomized controlled trial  This link exits the ClinicalTrials.gov site Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale  This link exits the ClinicalTrials.gov site 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  This link exits the ClinicalTrials.gov site A Multidimensional Approach to Individual Differences in Empathy  This link exits the ClinicalTrials.gov site Positive emotion dispositions differentially associated with Big Five personality and attachment style  This link exits the ClinicalTrials.gov site

Publications:
Lichtman JH, Bigger JT Jr, Blumenthal JA, Frasure-Smith N, Kaufmann PG, Lespérance F, Mark DB, Sheps DS, Taylor CB, Froelicher ES; American Heart Association Prevention Committee of the Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Epidemiology and Prevention; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research; American Psychiatric Association. Depression and coronary heart disease: recommendations for screening, referral, and treatment: a science advisory from the American Heart Association Prevention Committee of the Council on Cardiovascular Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Interdisciplinary Council on Quality of Care and Outcomes Research: endorsed by the American Psychiatric Association. Circulation. 2008 Oct 21;118(17):1768-75. doi: 10.1161/CIRCULATIONAHA.108.190769. Epub 2008 Sep 29.

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Responsible Party: Christina Luberto, Clinical Psychology Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03878160     History of Changes
Other Study ID Numbers: 2018P001000
1K23AT009715-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christina Luberto, Massachusetts General Hospital:
Mindfulness
Acute Coronary Syndrome
Videoconferencing
Depression

Additional relevant MeSH terms:
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Syndrome
Depression
Depressive Disorder
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Disease
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms