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Mindfulness based cognitive therapy (MBCT) for chonic depression


- candidate number19652
- NTR NumberNTR4843
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2014
- Secondary IDsNL 4135709112 CMO
- Public TitleMindfulness based cognitive therapy (MBCT) for chonic depression
- Scientific TitleMindfulness based cognitive therapy (MBCT) for chronic depression
- ACRONYMDeMeTer (Depressie Mindfulness en Therapieresistentie)
- hypothesis
- Healt Condition(s) or Problem(s) studiedChronic depression , Depressive Disorder , Mindfulness, Cognitive behavior therapy
- Inclusion criteria- Patients with a major depressive disorder (according to DSM-IV) with a duration of one year or longer. Patients have responded insufficiently (IDS> 21, moderate depression) to antidepressant medication and a psychotherapy protocol (cognitive behavioural therapy or interpersonal therapy).
- Age: > 18 years
- Exclusion criteria-bipolar disorder
-any primary psychotic disorder
-current alcohol or drug misuse
-recent Electro Convulsive Therapy
-clinically relevant neurological of somatic illness
-insufficient knowlegde of the dutch language
-earlier treatment with MBCT
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- control[default]
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jan-2013
- planned closingdate30-sep-2016
- Target number of participants94
- InterventionsIntervention:
Mindfulness Based Cognitive Therapy (MBCT)

Waitlist group:
Treatment as ususal (TAU)
- Primary outcomeDepressive symptoms: Inventory of Depression Symptomatology (IDS)
- Secondary outcome-Rumination (Ruminative Response Scale, RRS)
-Mindfulness Skills (Five Facet Mindfulness Questionnaire, FFMQ)
-Self Compassion (Self Compassion Scale, SCC) -Quality of Live (WHO-QOL)
-Positive and Negative Affect (Positive and Negative Affect Scale, Panas)
-Current depressive episode according to DSM-IV criteria (psychiatric interview)
- TimepointsAll primary and secondary outcome measures are measured at all time points.

Intervention group:
1. baseline
2. end of treatment (after completing MBCT)
3. follow-up at 3 months
4. follow-up at 6 months

Waitlist group:
1. baseline
2. end of control period (8-12 weeks after baseline)
3. end of treatment (after completing MBCT)
4. follow-up at 3 months
5. follow-up at 6 months
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. M. Cladder-Micus
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J. Spijker
- Sponsor/Initiator Radboud University Medical Center Nijmegen, Pro Persona
- Funding
(Source(s) of Monetary or Material Support)
Pro Persona/Overwaal, Fonds Psychische Gezondheid, Radboud University Medical Centre Nijmegen
- Publications
- Brief summary
- Main changes (audit trail)17-okt-2015: Change secondary outcome: Positive and Negative Affect Scale (Panas) is not a secondary outcome in this study, but is used in a additional study.
- RECORD14-okt-2014 - 8-mrt-2017


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