|- candidate number||12241|
|- NTR Number||NTR3397|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-apr-2012|
|- Secondary IDs||NL19795.060.07 CCMO|
|- Public Title||Effects of a mindfulness based stress reduction program on psychological and physiological measures in cardiac patients.|
|- Scientific Title||Effects of a mindfulness based stress reduction program on psychological and physiological measures in percutaneous coronary intervention (PCI) patients.|
|- hypothesis||Compared to a control group, the mindfulness group intervention is expected to result in:|
1. A decrease in symptoms of psychological distress;
2. An increase in quality of life;
3. An increase in heart rate variability;
4. A decrease in blood pressure in those with elevated blood pressure;
5. Decrease in low-grade inflammation.
|- Healt Condition(s) or Problem(s) studied||Percutaneous Coronary Intervention (PCI), Anxiety, Depression, Quality of life, Hypertension, Psychological stress|
|- Inclusion criteria||1. Patients who had a percutaneous coronary intervention in the previous month;|
2. Age 18-70.
|- Exclusion criteria||1. Serious medical co-morbidity (e.g., heart failure; cancer);|
2. Serious psychiatric co-morbidity (e.g., suicidal ideation; psychoticism);
3. Past or present brain-damage;
4. Inadequate knowledge of the Dutch language;
5. Acute infection in past two weeks;
6. Use of anti-inflammatory drugs, except aspirin.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2008|
|- planned closingdate||1-jul-2012|
|- Target number of participants||128|
|- Interventions||The applied group (6-8 patients) intervention is a mindfulness training, 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 control group is an active control group: A self-help intervention consisting of a booklet based on the group training and written by the same clinical psychologist. The psychoeducation and exercises are identical to the information given in the group intervention. The participants who receive the self-help booklet are asked to read the theory and to practice the exercises daily as indicated.
|- Primary outcome||Psychological distress (symptoms of perceived stress, anxiety and depression) at post-intervention.|
|- Secondary outcome||1. Vitality;|
2. Quality of life, blood pressure;
3 Heart rate variability;
4. C-reactive protein at post-intervention;
5. Psychological distress (symptoms of perceived stress, anxiety and depression) at post-intervention at 1-year follow-up.
|- Timepoints||1. Pre-intervention (T1);|
2. Post-intervention (T2);
3. 1-year follow-up (T3).
The following measures are taken at all time points:
Perceived Stress Scale (PSS); Symptoms of Anxiety and Depression (SAD-4); WHOQoL-Bref and Seattle Angina Questionnaire (for quality of life): Global Mood Scale (GMS); Freiburg Mindfulness Inventory-short (FMI-s); Balanced Index of Psychological Mindedness.
The following measures are taken at T1 and T2: Systolic and diastolic blood pressure (means of 3 measurements); heart rate variability; C-reactive protein.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. I. Nyklicek|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I. Nyklicek|
|- Sponsor/Initiator ||Tilburg University, Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Tilburg University, Catharina Hospital Eindhoven|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||13-apr-2012 - 21-apr-2012|