|- candidate number||21372|
|- NTR Number||NTR5030|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jan-2015|
|- Secondary IDs||V-065-15-SM-AS-Major23092014 |
|- Public Title||A Cognitive control training for depressed patients|
|- Scientific Title||A Cognitive control training for depressed patients|
|- ACRONYM||CCT in MDD|
1.CCT reduces rumination in depressed patients.
2. The effects of CCT on working memory effect generalize to other Working memory tasks (neutral and emotional).
3. CCT has an effects on the mood of depressed patients.
|- Healt Condition(s) or Problem(s) studied||Major depressive disorder (MDD)|
|- Inclusion criteria||- diagnosed with Major Depressive Disorder by therapist|
- <11 points on the BDI-II
- age between 18 & 65 years
- sufficient German language skills
|- Exclusion criteria||- a neurologocal disorder, epilepsia included and diagnosed by a physician|
- acute suicidality
- diagnosis of actual substance dependency
- past or present psychotic episodes
- less than 8 years of schooling
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate|
|- Target number of participants||80|
|- Interventions||Active training: An adaptive version of the Paced Auditory Serial Addition Task (PASAT) will be used for a cognitive control training. The numbers of the PASAT (1 to 9) will be recorded in German and presented in a random order for the patients. Patients have to listen to these serially presented digits and will be asked to add each new digit to the digit that preceded it (i.e., sum of the last two digits). To respond, they need to select the correct response on the screen with a mouse click. The adaptive PASAT version starts with a 4000ms inter-stimulus interval and speeds up by 100ms when patients get four consecutive items correct. On the other hand, it slows down by 100ms when patients miss four consecutive items, therefore keeping the performance relatively constant and equating the task for difficulty across patients and sessions. Patients will complete 4 blocks or 100 trials each (about 20 minutes of training)|
placebo training: Patients will be asked to respond to serially presented digits with a mouse click on the screen. However, the difference with the PASAT is that patients in the placebo training will be asked to simply name/select the digit that was last heard, without making a sum of the last two digits. This placebo task for cognitive control training will also be adaptive to the patients' performance: the task starts with a 4000 ms inter-stimulus interval and the time of this interval will be speeded up by 100 ms when patients get four consecutive items correct, but will slow down with 100 ms after four errors. Patients will complete 4 blocks of 100 trials each.
|- Primary outcome||rumination (RSQ, MRSI)|
emotion regulation (ERQ, CERQ)
|- Secondary outcome||breathing focus task (Hirsch, Hayes & Mathews, 2009) |
Internal Shift Tast (De Lissnyder, Koster, & De Raedt, 2012)
Random number generation task
post (2 weeks of training)
follow up (standard done by clinic)
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||prof. dr.
|- CONTACT for SCIENTIFIC QUERIES||prof. dr.
|- Sponsor/Initiator ||Radboud University Nijmegen, Behavioural Science Institute, Fakultät für Human- und Sozialwissenschaften der Technischen Universität Chemnitz auf Vorbegutachtung|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Center Nijmegen|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||8-jan-2015 - 12-apr-2015|