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N/A Completed N=27 Other

MBCT Delivered Via Group Videoconferencing for ACS Patients With Elevated Depression Symptoms

Source: ClinicalTrials.gov NCT03878160 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants Reporting Changes After ACS — 3; 3; 10; 1 participants

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.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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