|- candidate number||6819|
|- NTR Number||NTR2145|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-dec-2009|
|- Secondary IDs||2008.13.005 Diabetes Fonds|
|- Public Title||The evaluation of a mindfulness-based psychological intervention for patients with diabetes type 2 and emotional problems.|
|- Scientific Title||The treatment of co-morbid emotional problems in people with diabetes type 2: Evaluation of a mindfulness-based psychological intervention.|
|- ACRONYM||DiaMind (Diabetes and Mindfulness) project|
|- hypothesis||1. A mindfulness-based psychological intervention (MBSR) will increase the emotional well-being and quality of life of patients with type 2 diabetes; |
2. MBSR will improve self-care behavior;
3. MBSR will have a positive effect on blood pressure and heart rate variability in T2D patients with a high blood pressure.
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Anxiety, Depressive symptoms, Emotional problems|
|- Inclusion criteria||1. Diabetes type 2 diabetes;|
2. Age >18 years;
3. Self-reported stress complaints;
4. Mastery of the Dutch language.
|- Exclusion criteria||1. Severe psychopathology;|
2. Severe physical co morbidity;
3. Already receiving treatment in the mental health care.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-jun-2013|
|- Target number of participants||160|
|- Interventions||Mindfulness-based psychological intervention (MBSR): the mindfulness-based intervention will be given in eight weekly sessions (including one booster session) of two hours to groups of eight to ten persons. The intervention will be based on a combination of existing protocols. Besides education about the mechanisms of stress, coping, and relaxation, there will be much emphasis on practicing mindfulness (e.i. breathing, moving, and observing and letting-go thoughts with non-judgemental attention) and there will be group discussions about relevant matters concerning the exercises and daily living. |
Wait-list control group: The wait-list control group will continue to receive regular care (care-as-usual) and will be placed on a wait-list to receive the MBSR intervention six months later. Both interventions will be given by a psychologist.
|- Primary outcome||Questionnaires:|
1. Perceived stress (PSS10);
2. Affect (POMS);
3. Anxiety and depression (HADS);
4. Health state (SF12).
|- Secondary outcome||Questionnaires:|
1. Type D personality (DS-14);
2. Personality (EPQ or NEO-FFI);
3. Mindfulness (FFMQ or FMI);
4. Diabetes self-care behavior (SDSCA);
5. Diabetes acceptance (AADQ);
6. Diabetes related problems (PAID).
1. Blood pressure;
2. Heart rate variability;
3. Glycemic control, HbA1c.
1. T1 (baseline);
2. T2 (at 4 weeks);
3. T3 (post intervention at 8 weeks);
4. T5 (follow-up at 6 months post intervention).
In addition, the wait-list control group will receive three more measurements (T6, T7 and T8).
Blood pressure and heart rate variability: T1 and T3.
HbA1c measurement: T1 and T4 (one month post intervention).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. PhD. Jenny Son, van|
|- CONTACT for SCIENTIFIC QUERIES||MSc. PhD. Jenny Son, van|
|- Sponsor/Initiator ||Tilburg University, Faculty of Social and Behavioural Sciences, Department of Psychology and Health , Center of Research on Psychology in Somatic Diseases (CoRPS)|
(Source(s) of Monetary or Material Support)
|Dutch Diabetes Research Foundation, Tilburg University|
|- Publications||van Son et al. BMC Public Health 2011, 11:131 http://www.biomedcentral.com/1471-2458/11/131
|- Brief summary||A considerable proportion of the patients with type 2 diabetes experience emotional problems, varying from disease-specific worries to general symptoms of anxiety and depression. This emotional well-being is related to other unfavorable outcomes, like reduced quality of life, worse self-care, reduced glycemic control, complications, and mortality. A mindfulness-based psychological intervention may increase the emotional well-being in patients with diabetes, since the intervention has proven to be successful in various other patient populations earlier. The objectives of this randomized controlled trial (RCT) are: 1) to test the effectivity of a mindfulness-based psychological intervention (MBSR) aimed at increasing the emotional well-being and quality of life of patients with type 2 diabetes; 2) to examine which group of patients, with which characteristics (like the extent of complications and personality) will benefit most from the intervention; 3) to investigate the effect of the intervention on self-care, health care consumption behavior, glycemic control, and blood pressure. The recruitment of patients will take place in collaboration with one or two hospitals, during the standard annual checkup for T2D patients.|
|- Main changes (audit trail)||26-3-2014: gepubliceerd protocol toegevoegd aan publicaties - LH|
|- RECORD||18-dec-2009 - 26-mrt-2014|