|- candidate number||6687|
|- NTR Number||NTR2096|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2009|
|- Secondary IDs||NL29851.097.09 METiGG|
|- Public Title||Mindfulness as a preventive intervention: a randomized controlled trial.|
|- Scientific Title||Mindfulness as a preventive intervention: a randomized controlled trial.
|- hypothesis||The purpose of the study is to conduct a randomised controlled trial with the training course 'Less stress through mindfulness' as an intervention to study the: |
1. Effectiveness in terms of reduction of psychological symptoms (depressive symptoms and anxiety);
2. Effectiveness in terms of improvements in positive mental health, psychological flexibility and mindfulness.
The hypothesis is that the interventiongroup is superior to a comparison group, which offered no preventive intervention, in terms of clinical outcomes (reduction of psychological symptoms and improvement of positive mental health, psychological flexibility and mindfulness).
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety disorders|
|- Inclusion criteria||Adults (male and female) of 18 years and older with mild tot moderate psychological distress. |
|- Exclusion criteria||1. Serious psychopathology requiring immediate treatment measured with the M.I.N.I.-Plus. When there is a serious depression or anxiety disorder, the clients will be referred to GGNet, Dimence, Mediant or GGZ Leiden for a treatment. There has been an agreement with the Health organisations that the clients will be seen shortly (within a week);|
2. People recently started on pharmacological treatment, within three months (before the start of the research). If so, it is not well deductable if the effects are to be attributed to the intervention or the pharmacological treatment;
3. Currently undergoing psychological (self-help)treatment at a mental health institution;
4. Not enough time for following the training;
5. Inadequate control of the Dutch language (reading or learning difficulties).
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2010|
|- planned closingdate||7-jan-2011|
|- Target number of participants||120|
|- Interventions||TRAINING COURSE. The mindfulness training is a targeted intervention group of 11 meetings of 1½ hours and possibly a follow-up session after 4-6 weeks, which is conducted in groups of about 8 to 15 participants. This intervention is based on MBCT. The training consists of three elements: attention (session 1, 2 and 3), acceptance (5, 7, 9 and 10) and dealing differently with thoughts (session 4, 6 and 8). The last meeting has evaluation as a theme. In the first sessions participants learn how they can consciously focus their attention on the here and now. They also learn how to cope with periods of distraction from what they are doing and return to the present moment. Two basic exercises will be practised: the body scan and the focus of attention on breathing. The practice of mindfulness in daily life will be extensively dwelt on. In meetings about acceptance participants learn how they can be accept things as they are. The importance of the concepts are discussed and exercises are done to learn to accept negative emotions and thoughts. When dealing differently with thoughts, the emphasis is on learning that thoughts are not the basis of everyone's identity. One learns to observe thoughts as emerging and disappearing phenomena, take way from thoughts and not to respond to negative emotions and thoughts. For more information see the appendix (page 15 of the protocol). |
CONTROLGROUP. The controlgroup is is offered the same intervention after 3 months. They will be placed in a waitinglist group, but are free to use other kinds of interventions.
|- Primary outcome||Reduction of psychological symptoms (depression, anxiety).|
|- Secondary outcome||Improvement of positive mental health, psychological flexibility and mindfulness.|
|- Timepoints||The subjects have to work 1½ hours weekly for 11 weeks attending the course, with possibly a follow-up session after 4 to 6 weeks, and do exercises at home 30 minutes a day. At the beginning of the study there will be an introductory meeting of 30 minutes, plus a section of the M.I.N.I.-Plus of 15-30 minutes of duration. Furthermore, subjects are asked to fill in questionnaires at three times, with a load of approximately 1½-2 hours in total.
The following validated instruments will be used:
1. Depression and Anxiety: M.I.N.I-Plus;
2. Depression: Center for Epidemiologic Studies Depression Scale (CES-D);
3. Anxiety: HADS-A;
4. Psychological flexibility: Acceptance and action questionnaire II (AAQ-II);
5. Mindfulness: Five Facet Mindfulness Questionnaire (FFMQ);
6. Positive mental health: Mental Health Continuum – short form (MHC-SF);
7. Demografic variables: gender, age, education, marital status, cultural background, medication.
At the end of the course participant receive an evaluationform. The participants can indicate whether the course met their expectations, what they felt about the duration and content of the course, and what they felt about the contact with the teachers and the teaching material (degree of difficulty, amount of text, assignments, etc.). They can also give recommendations about the material.
1. Baseline (T01) at the introductory meeting;
2. Pretest (T02) directly before the start of the course;
3. Posttest (T1) 3 months after the baseline;
4. Follow-up (T2) 3 months after the end of the course.
With exception of the demographic variables and the M.I.N.I.-Plus (only at baseline T01), all instruments will be administered at all three measurement points.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Wendy Pots|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E.T. Bohlmeijer|
|- Sponsor/Initiator ||University of Twente|
(Source(s) of Monetary or Material Support)
|University of Twente|
|- Brief summary||Depression and anxiety disorders are common health problems among adults in the Netherlands. These disorders have a major negative impact on the functioning and quality of life of the patient. Moreover, these disturbances lead to enormous health care costs annually and increased use of health services. The main risk factor for developing mental disorders is the presence of moderate depression and anxiety. Indicated prevention aims to reduce psychological symptoms and increase psychological flexibility thus decreasing the risk of mental disorders. GGNet has developed a preventive mindfulness training for adults with mild and moderate mental symptoms. This course is based on the principles of Mindfulness Based Cognitive Therapy (MBCT). The University of Twente will perform (in cooperation with GGNet, Dimence, Mediant and GGZ Leiden) an investigation into the effects of the course. The course is compared with a waiting list control group. Primary outcomes are anxiety and depression. Secondary outcomes are positive mental health, experiential avoidance and mindfulness.|
|- Main changes (audit trail)|
|- RECORD||2-nov-2009 - 12-mrt-2010|