N/A
N=27
MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms
Acute Coronary Syndrome · Depression · Myocardial Infarction · Unstable Angina · STEMI
Bottom Line
View on ClinicalTrials.gov: NCT03878160 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants Reporting Changes After ACS — 3; 3; 10; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individual Interview (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Changes After ACS |
3; 3; 10; 1; 0; 5 | — |
| PRIMARY Number of Participants With Perspectives on MBCT |
3; 8; 8; 3; 6; 8 | — |
| PRIMARY Number of Participants With Perspectives on Videoconferencing |
3; 7; 8; 5; 5; 7 | — |
| PRIMARY Number of Participants With Perspectives on Blood Spot Data Collection |
5; 7; 8; 2; 5; 2 | — |
| SECONDARY Five Factor Mindfulness Questionnaire- 15 Item (FFMQ-15) |
8; 9; 10; 11; 9; 13 | — |
| SECONDARY Perceived Stress Scale-4 (PSS-4) |
12; 14; 6 | — |
| SECONDARY Positive Affect Negative Affect Schedule (PANAS) |
22; 26; 34 | — |
| SECONDARY Rumination Response Scale (RRS) |
41; 51.5; 31 | — |
| SECONDARY Self-Other Four Immeasurables (SOFI) Scale |
15; 12.5; 16 | — |
| SECONDARY Interpersonal Reactivity Index (IRI) |
41; 39; 45 | — |
| SECONDARY Medical Outcomes Study - Specific Adherence Scale (MOS- SAS) |
11; 10; 13 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
10.5; 16; 1.5 | — |
| SECONDARY Short-Form-12 (SF-12) |
26; 22; 40 | — |
| SECONDARY Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-29-PF) |
18; 12; 20 | — |
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.
Eligibility Criteria
Inclusion criteria for depressed sample:
- 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
Exclusion criteria for depressed sample :
- Active suicidal ideation or past-year psychiatric hospitalization
- Non-English-speaking
- Cognitive impairments preventing informed consent.
Inclusion criteria for non-depressed sample:
- Lifetime ACS per medical record (for Partners' patients only) and/or patient confirmation
- Age 35-85 years
- Access to high-speed internet
Exclusion criteria for non-depressed sample:
- Active suicidal ideation or past-year psychiatric hospitalization
- Non-English-speaking
- Cognitive impairments preventing informed consent.
Data sourced from ClinicalTrials.gov (NCT03878160). 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.