Luberto 2021.
| Study name | MBCT via group videoconferencing for acute coronary syndrome patients with depressive symptoms: a pilot RCT |
| Methods | RCT design: 2‐arm parallel‐group trial Total N randomised: 50 Length of follow‐up: 3 months Analysis: not specified |
| Participants | Location: USA Number of study centres and setting: Department of Psychiatry, Massachusetts General Hospital CAD criteria: acute coronary syndrome specified by medical records or patient confirmation, or both Depression criteria: current elevated depression symptoms (PHQ‐9 greater than or equal to 5) Other entry criteria: 35 to 85 years of age, access to high‐speed internet Exclusion criteria: active suicidal ideation or past‐year psychiatric hospitalisation (per patient report or medical record review, or both); non‐English‐speaking; cognitive impairments preventing informed consent per medical record review and/or cognitive screen less than or equal to 4; patient deemed to be unable to complete the study protocol or has a condition that would likely interfere with the study |
| Interventions | Intervention 1: 8 virtually delivered MBCT sessions (approximately 1.5 hours each) to regulate distress and choose healthy behaviours, as well as learn about cardiac health Intervention 2: attention‐matched control comprising 8 weekly virtual group sessions that focus on cardiac health and depression education Duration of treatment: 8 weeks |
| Outcomes | Depression measured by the HADS and PHQ‐9 Quality of life measured by PROMIS‐Physical Function and 1 item of 12‐Item Short Form Health Survey Inflammatory biomarkers, interleukin 6, tumour necrosis factor‐α, and C‐reactive protein measured by whole dried blood spot sample collection All outcomes measured 1 week before and after the intervention and at 3 months postintervention. |
| Starting date | April 2021 |
| Contact information | Christina Luberto, Assistant Professor, Department of Psychiatry, Harvard Medical School; Massachusetts General Hospital T: 617‐643‐9453 E: cluberto@mgh.harvard.edu Elyse Park, PhD, MPH T: 617‐724‐6836 E: epark@mgh.harvard.edu |
| Notes |