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Predictors of effects of a mindfulness based psychological treatment on psychological well-being in cardiac rehabilitation patients.


- candidate number12308
- NTR NumberNTR3419
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-apr-2012
- Secondary IDsNL34522.060.11 CCMO
- Public TitlePredictors of effects of a mindfulness based psychological treatment on psychological well-being in cardiac rehabilitation patients.
- Scientific TitlePredictors of effects on psychological well-being and quality of life of a mindfulness based intervention in cardiac rehabilitation patients.
- ACRONYMMindfulHeart II
- hypothesisIt 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) studiedCoronary artery disease, Emotional problems, Depression, Anxiety
- Inclusion criteria1. Participants in cardiac rehabilitation of St. Catharina Hospital Eindhoven;
2. Age between 18-80 years.
- Exclusion criteria1. Severe psychiatric (e.g., suicidal ideation; psychoticism) or somatic (e.g., heart failure; cancer) comorbidity;
2. Insufficient mastery of Dutch.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-sep-2013
- Target number of participants128
- InterventionsMindfulness-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 outcomePsychological well-being (anxiety, depression, psychological stress).
- Secondary outcome1. Quality of life;
2. Self-esteem.
- TimepointsT1: 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. I. Nyklicek
- CONTACT for SCIENTIFIC QUERIESDr. I. Nyklicek
- Sponsor/Initiator Tilburg University, Catharina Hospital
- Funding
(Source(s) of Monetary or Material Support)
Tilburg University, Catharina Hospital Eindhoven,
- PublicationsN/A
- Brief summaryThis 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)
- RECORD27-apr-2012 - 19-mei-2012


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