|- candidate number||12308|
|- NTR Number||NTR3419|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-apr-2012|
|- Secondary IDs||NL34522.060.11 CCMO|
|- Public Title||Predictors of effects of a mindfulness based psychological treatment on psychological well-being in cardiac rehabilitation patients.|
|- Scientific Title||Predictors of effects on psychological well-being and quality of life of a mindfulness based intervention in cardiac rehabilitation patients.|
|- ACRONYM||MindfulHeart II|
|- hypothesis||It is hypothesized that the mindfulness based intervention will be associated with a reduction in psychological symptoms and increase in quality of life. In addition, it is hypothesized that patients scoring high on psychological mindedness at baseline will show larger benefits compared to those low in psychological mindedness. No effects of attention deficits or hyperactivity are anticipated.|
|- Healt Condition(s) or Problem(s) studied||Coronary artery disease, Emotional problems, Depression, Anxiety|
|- Inclusion criteria||1. Participants in cardiac rehabilitation of St. Catharina Hospital Eindhoven;|
2. Age between 18-80 years.
|- Exclusion criteria||1. Severe psychiatric (e.g., suicidal ideation; psychoticism) or somatic (e.g., heart failure; cancer) comorbidity;|
2. Insufficient mastery of Dutch.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-sep-2013|
|- Target number of participants||128|
|- Interventions||Mindfulness-based stress reduction versus treatment as usual (TAU).
The applied mindfulness-based stress reduction is a group (6-8 patients) intervention, which is loosely based on the Mindfulness-Based Stress Reduction (MBSR) program, as developed by Kabat-Zinn (1990). The adjusted program in this study is less intensive, including only three weekly 90 to 120 minutes meetings and an additional evaluation session two weeks later.
The treatment-as-usual (TAU) group consists of those cardiac rehabilitation patients who do not sign up for the intervention. They will be matched with the treatment group regarding age, sex, education, and level of baseline psychological well-being.
|- Primary outcome||Psychological well-being (anxiety, depression, psychological stress).|
|- Secondary outcome||1. Quality of life;|
|- Timepoints||T1: Before intervention. All variables will be measured: anxiety and depression (Hospital Anxiety and Depression Scale), stress (Perceived Stress Scale), Quality of Life (QLMI), self-esteem (Rosenberg Self-Esteem Scale), psychological mindedness (BIPM), symptoms of ADHD.|
Also at T2 (after the intervention) and T3 (one year after the intervention) all these questionnaires will be completed.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. I. Nyklicek|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I. Nyklicek|
|- Sponsor/Initiator ||Tilburg University, Catharina Hospital|
(Source(s) of Monetary or Material Support)
|Tilburg University, Catharina Hospital Eindhoven, |
|- Brief summary||This study investigates predictors of effects on psychological well-being and quality of life of a mindfulness based intervention in cardiac rehabilitation patients.|
It is hypothesized that the mindfulness based intervention will be associated with a reduction in psychological symptoms and increase in quality of life. In addition, it is hypothesized that patients scoring high on psychological mindedness at baseline will show larger benefits compared to those low in psychological mindedness.
|- Main changes (audit trail)|
|- RECORD||27-apr-2012 - 19-mei-2012|