|- candidate number||10870|
|- NTR Number||NTR3226|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jan-2012|
|- Secondary IDs||NL37811.097.11 CCMO|
|- Public Title||Treatmentform with Mindfulness-Based Cognitive Therapy versus treatment as usual in a group of outpatients with chronic anxiety and / or mood disorder.|
|- Scientific Title||Treatmentform with MBCT vs TAU in outpatients with chronic anxiety and/or mood disorder.|
|- hypothesis||1. A treatment program with attentional control training (MBCT) leads to significant more reduction in anxiety- and moodsymptoms and significant more experienced mental health than the regular treatment form;|
2. There is a positive correlation between on the one hand symptom reduction and increased experienced mental health and on the other hand both increased mindfulness skills and diminished emotional avoidance;
3. There is no significant difference in effect of a treatmentform with attentional control training on symptom reduction and mental health between respectively primary anxiety or depressive disorder and different education levels;
4. A treatmentform with attentional control training leads to significant more symptom reduction and increased experienced mental health if the complaints are more serious at the start and if there has been more practice-time during treatment.
|- Healt Condition(s) or Problem(s) studied||Chronic anxiety, Chronic mood disorder, MBCT, Mindfulness|
|- Inclusion criteria||1. Adults of 18 years and older with an anxiety and / or mood disorder as primary diagnoses;|
2. Has been treated for at least two years according to multi disciplinairy guidelines (Trimbos) for this disorder but symptoms still remained and disturb daily functioning;
3. Have an insight into their own situation or the capability to develop this, enough abstraction ability and reading skills;
4. Sufficient skills to function in a group, at least capable to express themselves and listen to others (including sufficient Dutch speaking).
|- Exclusion criteria||1. Prior experience with mindfulness therapy;|
2. The presence of a current severe Axis I disorders (eg severe depression), and / or current suicidal tendencies;
3. Acute medical intervention is indicated;
4. Classified mental retardation (IQ = 84 or lower);
5. Alcohol and / or substance abuse / dependence.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-jun-2014|
|- Target number of participants||80|
|- Interventions||MBCT, Mindfulness-Based Cognitive Therapy, is a groupprogramme consisting of mindfulness skills as developed by Kabat Zinn et al (2002) and elements from cognitive therapy. MBCT is aimed at training awareness of one's internal and external experiences at any given moment, without judging these experiences. If these attentionskills are mastered one can choose what to do with these experiences; solve them through a direct behavioral approach or by treating them as mere thoughts and feelings and see them disappear again (Segal et al 2008 p. 80). Segal described the core skill of MBCT as follows; "learning how to get out of self-perpetuating cognitive habits and continue through (focused) attention and letting go, because it is the repeated attempts to escape and avoid unpleasant feelings that maintains the negative cycles" (Segal et al 2008 p. 84).
Treatment 'as usual' in this patientgroup is at present often supportive, structuring sessions with psychiatric nurses aimed at "increasing adaptation,selfmanagement, autonomy and increase use of social support" (handbook nursing Dimence ed).
|- Primary outcome||1. Symptom reduction increase after MBCT compared to 'treatment as usual' in outpatients with chronic anxiety and / or mood disorders?|
2. Perceived mental health improved after MBCT compared to 'treatment as usual' in outpatients with chronic anxiety and / or mood disorders?
|- Secondary outcome||1. Can the expected effect of MBCT on symptom reduction and mental health be explained by increased mindfulness skills and / or decreased emotional avoidance?|
2. Can the expected effect of MBCT on symptom reduction and mental health be predicted by independent variables such as diagnosis, training, symptom levels at the start and / or exercise time?
|- Timepoints||Questionaires before MBCT program, after completing MBCT program of 8 weeks and 2 and 3 months after completing MBCT program. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator ||Dimence|
(Source(s) of Monetary or Material Support)
|- Brief summary||This study aimes at exploring whether the treatment program with MBCT is more effective than treatment "as usual" in terms of symptomreduction and increase of mental health in a group of outpatients with chronic anxiety and mood symptoms. Secondly the current research is looking for the link with possible prospective dependent determinants like level of mindfulness skills, attitude to experiencing negative emotions and independent variables as education, diagnosis, symptomlevels at start of research, exercise time during and after the treatment. The conclusions from this research can generate evidence about the effectiveness of this treatmentprogram. In addition, the conclusions can contribute to a good indication for the method within this patientgroup.
Randomized controlled trial with two parallel groups, namely:
1. Experimental group with MBCT training;
2. Control group with regular treatment, consisting of therapy sessions with psychiatric nurse.
In both groups, the current drug treatment can be continued.
Primary endpoint of this study is symptom reduction and secondary outcome is perceived mental health. Next to demographic variables such as gender and education patients will also be asked to register practice time. After the researchperiod participants can still attend either treatment. Within the study, before and after MBCT training, 2 and 4 months after the end of training, participants are asked to fill out five questionnaires, namely HADS-A and HADS-D (symptoms), MHC-SF (mental health), FFMQ (mindfulness skills), AAQ (emotional avoidance). Also, the participants are asked to daily register duration and frequency of time spend on the information/ feedback/ exercices that has been offered in the sessies.
|- Main changes (audit trail)|
|- RECORD||6-jan-2012 - 19-jan-2012|