NCT03878160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 4, 2021

Completed
Last Updated

June 4, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

February 26, 2019

Results QC Date

February 17, 2021

Last Update Submit

May 10, 2021

Conditions

Acute Coronary SyndromeDepressionMyocardial InfarctionUnstable AnginaSTEMINSTEMI - Non-ST Segment Elevation MI

Keywords

MindfulnessAcute Coronary SyndromeVideoconferencingDepression

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15)

    30-90-minute study session

  • Perceived Stress Scale-4 (PSS-4)

    30-90-minute study session

  • Positive Affect Negative Affect Schedule (PANAS)

    30-90-minute study session

  • Rumination Response Scale (RRS)

    30-90-minute study session

  • Self-Other Four Immeasurables (SOFI) Scale

    30-90-minute study session

  • +5 more secondary outcomes

Study Arms (3)

Women and Men, <2 years, Individual Interview

OTHER

Individual interviews for women and men who have experienced an ACS within the past 2 years and have elevated depression symptoms.

Other: Individual Interview

Women and Men, >2 years, Individual Interview

OTHER

Individual interviews for women and men who have experienced an ACS greater than 2 years ago and have elevated depression symptoms.

Other: Individual Interview

Women and Men, Lifetime History of ACS, Individual Interview

OTHER

Individual interviews for women and men who have experienced an ACS at some point in their life and do not have elevated depression symptoms.

Other: Individual Interview

Interventions

Individual InterviewOTHER

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.

Women and Men, <2 years, Individual InterviewWomen and Men, >2 years, Individual InterviewWomen and Men, Lifetime History of ACS, Individual Interview

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
  • Current elevated depression symptoms (PHQ-9≥10)
  • Age 35-85 years
  • Access to high-speed internet

You may not qualify if:

  • Active suicidal ideation or past-year psychiatric hospitalization
  • Non-English-speaking
  • Cognitive impairments preventing informed consent.
  • Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
  • Age 35-85 years
  • Access to high-speed internet
  • Active suicidal ideation or past-year psychiatric hospitalization
  • Non-English-speaking
  • Cognitive impairments preventing informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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Related Links

MeSH Terms

Conditions

Acute Coronary SyndromeDepressionMyocardial InfarctionAngina, UnstableST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavioral SymptomsBehaviorInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Dr. Christina Luberto
Organization
Massachusetts General Hospital
cluberto@mgh.harvard.edu
617-643-9453

Study Officials

  • Christina M Luberto, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychology Fellow

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 18, 2019

Study Start

July 1, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 4, 2021

Results First Posted

June 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)