No registrations found.
ID
Source
Brief title
Health condition
cardiac patients undergoing a percutaneous coronary intervention; psychological stress, anxiety and depression; quality of life; elevated blood pressure
Sponsors and support
St. Catharina Hospital Eindhoven
St. Catharina Hospital Eindhoven
Intervention
Outcome measures
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.
Background summary
N/A
Study objective
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.
Study design
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.
Intervention
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.
Tilburg University<br>
POBOX 90153
I. Nyklicek
Tilburg 5000 LE
The Netherlands
+31 (0)13 4662391
i.nyklicek@tilburguniversity.edu
Tilburg University<br>
POBOX 90153
I. Nyklicek
Tilburg 5000 LE
The Netherlands
+31 (0)13 4662391
i.nyklicek@tilburguniversity.edu
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3245 |
NTR-old | NTR3397 |
CCMO | NL19795.060.07 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON32039 |