N/A
Completed N=24
MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT
Source: ClinicalTrials.gov NCT04799899 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Recruitment Feasibility: Percent of Participants Screened Eligible — 48 Participants
Summary
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Feasibility: Percent of Participants Screened Eligible |
48 | — |
| PRIMARY Recruitment Feasibility: Percent of Participants Enrolled |
24 | — |
| PRIMARY MBCT Feasibility: Percent of Participants Retained |
10 | — |
| PRIMARY Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment |
6 | — |
| PRIMARY Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice |
8 | — |
| PRIMARY Control Group Feasibility: Percent of Participants Retained |
8 | — |
| PRIMARY Control Group Feasibility: Percent of Participants Adherent to Treatment |
8 | — |
| PRIMARY Control Group Feasibility: Percent of Participants Adherent to Home Practice |
4 | — |
| PRIMARY Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems |
0; 0 | — |
| PRIMARY Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline |
11; 11 | — |
| PRIMARY Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention |
8; 7 | — |
| PRIMARY Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction |
8.67 | — |
| PRIMARY Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills |
8 | — |
| PRIMARY Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program |
8 | — |
| PRIMARY Control Group Acceptability: Ratings of Intervention Satisfaction |
8.13 | — |
| PRIMARY Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills |
8 | — |
| PRIMARY Control Group Acceptability: Percent of Participants Who Would Recommend the Program |
8 | — |
| PRIMARY Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction |
9.75; 9.63 | — |
| PRIMARY Blood Spot Acceptability: Blood Spot Collection Ease |
8.50; 8.38 | — |
| PRIMARY Blood Spot Acceptability: Blood Spot Collection Comfort |
9.10; 9.50 | — |
Eligibility Criteria
Inclusion Criteria
- Lifetime ACS per medical record and/or patient confirmation
- Current elevated depression symptoms (PHQ-9 greater than or equal to 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 less than or equal to 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 (NCT04799899). 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. Informational only — not medical advice.