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van CCT (UK)

van CCT (UK)

Effects of a mindfulness based stress reduction program on psychological and physiological measures in cardiac patients.

- candidate number12241
- NTR NumberNTR3397
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-apr-2012
- Secondary IDsNL19795.060.07 CCMO
- Public TitleEffects of a mindfulness based stress reduction program on psychological and physiological measures in cardiac patients.
- Scientific TitleEffects of a mindfulness based stress reduction program on psychological and physiological measures in percutaneous coronary intervention (PCI) patients.
- ACRONYMMindfulHeart
- hypothesisCompared 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) studiedPercutaneous Coronary Intervention (PCI), Anxiety, Depression, Quality of life, Hypertension, Psychological stress
- Inclusion criteria1. Patients who had a percutaneous coronary intervention in the previous month;
2. Age 18-70.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2008
- planned closingdate1-jul-2012
- Target number of participants128
- InterventionsThe 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 outcomePsychological distress (symptoms of perceived stress, anxiety and depression) at post-intervention.
- Secondary outcome1. 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.
- Timepoints1. 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 siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator Tilburg University, Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Tilburg University, Catharina Hospital Eindhoven,
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-apr-2012 - 21-apr-2012

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