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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 : August 8, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christina Luberto, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Qualitative focus group or individual interview on changes following an ACS [ Time Frame: one 30-90-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.
  • Qualitative focus group or individual interview on MBCT treatment preferences [ Time Frame: one 30-90-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.
  • Qualitative focus group or individual interview on treatment barriers [ Time Frame: one 30-90-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.
  • Qualitative focus group or individual interview on blood spot data collection [ Time Frame: one 30-90-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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03878160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Five Factor Mindfulness Questionnaire- 15 item (FFMQ-15) [ Time Frame: 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, 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, 30-90 minute time interval.
  • Perceived Stress Scale-4 (PSS-4) [ Time Frame: 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) [ Time Frame: 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. 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, 30-90 minute time interval.
  • Rumination Response Scale (RRS) [ Time Frame: 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 [ Time Frame: 30-90-minute study session ]
    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, 30-90 minute time interval.
  • Interpersonal Reactivity Index (IRI) [ Time Frame: 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) [ Time Frame: 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.
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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.
  • Short-Form-12 (SF-12) [ Time Frame: 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) [ Time Frame: 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.
  • Demographics [ Time Frame: 30-90-minute study session ]
    This is an 8-item questionnaire assessing the demographic information of each participant. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
  • Clinical History [ Time Frame: 30-90-minute study session ]
    This is a 7-item questionnaire assessing the cardiac history and related symptoms of each participant. Data collection for this measurement is cross-sectional, and is performed during one, 30-90 minute time interval.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms
Official Title  ICMJE Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Elevated Depression Symptoms
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 focus groups or 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 at least four in-person focus or virtual groups of ACS patients with elevated depression symptoms (approximately 8 participants per group, stratified by time since ACS; N = approximately 32 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). It will also involve approximately 1-2 focus groups of ACS patients (approximately 6-8 participants per group) without elevated depression symptoms (N=16; total N= approximately 48) 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 developed efforts. For patients who are not able to participate in a focus group (e.g. due to scheduling or transportation barriers), we will conduct individual interviews 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 or virtual focus group. Focus groups will be stratified by 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. Participants who are eligible and interested, but not able to participate in a focus group (e.g. due to scheduling or transportation barriers, because they have had multiple cardiac events and cannot be placed into just one of the focus group strata) will participate in either an in-person, telephone or videoconference individual interview. All procedures for the individual interviews will be the same as the focus groups, including the focus group interview guide, survey and participant remuneration. Data collected from both individual interviews and focus groups will be used to guide MBCT adaptations and research procedures for future clinical trials.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Approximately four in-person or virtual focus groups of patients with elevated depression symptoms stratified by time since ACS (e.g. within the past 2 years or greater than 2 years ago), with 2 groups for each strata. Each focus group will have approximately 4-8 participants. There will be approximately 1-2 focus groups of patients without elevated depression symptoms stratified by time since ACS, with 1 group for each strata. Each focus groups will have approximately 6-8 participants. We will also hold virtual or in-person individual interviews for patients that have experienced an ACS at some point in their life and are unable to participate in either of the focus groups.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Acute Coronary Syndrome
  • Depression
  • Myocardial Infarction
  • Unstable Angina
  • STEMI
  • NSTEMI - Non-ST Segment Elevation MI
Intervention  ICMJE
  • 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.
  • 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 the same interview guide as focus group participants. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
Study Arms  ICMJE
  • Women and Men, <2 years, Groups 1 and 2
    2 focus groups for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.
    Intervention: Other: Focus Group
  • Women and Men, >2 years, Groups 3 and 4
    2 focus groups for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.
    Intervention: Other: Focus Group
  • Women and Men, <2 years, Group 5
    1 focus groups for women and men who have experienced an ACS within the past 2 years and do not have elevated depression symptoms.
    Intervention: Other: Focus Group
  • Women and Men, >2 years, Group 6
    1 focus groups for women and men who have experienced an ACS greater than 2 years ago and do not have elevated depression symptoms.
    Intervention: Other: Focus Group
  • Women and Men, Lifetime History of ACS, Individual Interviews
    Individual interviews for women and men who have experienced an ACS at some point in their life and have elevated depression symptoms, but are unable to participate in either of the focus groups.
    Intervention: Other: Individual Interview
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
70
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Christina M Luberto, PhD 617-643-9453 cluberto@mgh.harvard.edu
Contact: Elyse Park, PhD (617) 724-6836 epark@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878160
Other Study ID Numbers  ICMJE 2018P001000
1K23AT009715-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christina Luberto, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Christina M Luberto, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP