Effectiveness of mindfulness-based stress reduction for improving quality of life in patients with cardiovascular disease: a randomised controlled trial

Conditions: atherosclerotic vascular disease
Cardiovascular disease
10011082
10003216

Registration Number: NL-OMON55428

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

a. Adult (18 years and older);
b. Established atherosclerotic cardiovascular disease (i.e. coronary artery
disease, ischemic heart failure, peripheral artery disease).

Exclusion Criteria

a. Current acute cardiovascular event (myocardial infarction, major stroke,
acute limb ischemia in prior 2 weeks)
b. Critical limb ischemia
c. Terminal illness
d. History of psychosis
e. Current severe psychiatric disorder
f. Current psychotherapy
g. Non-Dutch speaking
h. Cognitive impairment
i. Behavioural problems that distort group meetings
j. Active mindfulness/meditation or yoga practice within the past year
k. Current participation in another clinical trial that possibly interferes
with the study intervention or primary outcome

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quality of life measured with SF-12 questionnaire over the twelf month study<br /><br>period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Stress (PSS-10)<br /><br>- Depression (PHQ-9)<br /><br>- Anxiety (GAD-7)<br /><br>- Wellbeing (WHO-5)<br /><br>- Self-efficacy (GSES)<br /><br>- Fysical activity (EVS)<br /><br>- Nutrition (MEDAS)<br /><br>- Smoking (ja/nee)<br /><br>- Alcohol use (AUDIT-C)<br /><br>- Sleep (SQS)<br /><br>- Fatigue (VVV)<br /><br>- Body Mass Index (lichaamsgewicht- en lengte)<br /><br>- Medication adherence (SMAQ)<br /><br>- Cost-effectiveness (EQ-5D-5L)</p><br>