N/A
N=8
MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms
Acute Coronary Syndrome · Depression · Myocardial Infarction · Unstable Angina · STEMI
Bottom Line
View on ClinicalTrials.gov: NCT04231097 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Recruitment Feasibility: Percent of Participants Who Consent to Screening — 150 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MBCT intervention for ACS patients (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility: Percent of Participants Who Consent to Screening |
150 | — |
| PRIMARY Recruitment Feasibility: Percent of Participants Meeting Screening Criteria |
12 | — |
| PRIMARY Recruitment Feasibility: Percent of Eligible Patients Who Consent |
8 | — |
| PRIMARY MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention |
4; 4 | — |
| PRIMARY MBCT Feasibility: Percent of Participants Retained at Post-Intervention |
4; 4 | — |
| PRIMARY Videoconferencing Feasibility: Percent of Connections Dropped During Sessions |
1 | — |
| PRIMARY Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline |
4; 2 | — |
| PRIMARY Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention |
4; 4 | — |
| PRIMARY Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up |
4; 4 | — |
| PRIMARY Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted |
9 | — |
| PRIMARY MBCT Acceptability: Helpfulness for Mood |
6.98 | — |
| PRIMARY MBCT Acceptability: Usefulness of Session Components |
7.61 | — |
| PRIMARY Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use |
8.60 | — |
| PRIMARY Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys) |
8.81 | — |
| PRIMARY Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction |
9.75 | — |
| PRIMARY Blood Spot Acceptability: Ease of Blood Spot Collection |
7.3 | — |
| PRIMARY Blood Spot Acceptability: Discomfort of Blood Spot Collection |
9.5 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
3 | — |
Summary
Brief Summary: The aim of this study is to explore the initial feasibility and acceptability of (a) Mindfulness-Based Cognitive Therapy (MBCT) adapted for ACS patients; (b) the group videoconferencing delivery medium; and (c) dried blood spot research procedures, to inform refinements for a subsequent pilot RCT.
Eligibility Criteria
Inclusion Criteria
- Lifetime ACS per medical record and/or patient confirmation
- Current elevated depression symptoms (PHQ-9>5)
- Age 35-85 years
- Access to high-speed internet
Exclusion Criteria
- Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
- Non-English-speaking
- Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen < 4
- Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
Data sourced from ClinicalTrials.gov (NCT04231097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.