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Neurocognitive mechanisms of relapse prevention in depression, a fMRI-study


- candidate number22764
- NTR NumberNTR5368
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-aug-2015
- Secondary IDsNL53205.042.15 
- Public TitleNeurocognitive mechanisms of relapse prevention in depression, a fMRI-study
- Scientific TitlePredicting and Understanding Neurocognitive Mechanisms of Relapse Prevention: a randomized controlled trial of preventive cognitive therapy in remitted Major Depressive Disorder using fMRI and pupillometry
- ACRONYMNeurocognitive mechanisms of relapse prevention in depression
- hypothesisWe hypothesize that the capacity of the brainís prefrontal cortex to regulate emotional information is crucial for understanding and predicting preventive-CT-success.
- Healt Condition(s) or Problem(s) studiedDepression, Prevention, Relapse, fMRI
- Inclusion criteriabetween 18 - 55 years of age
current remission (>2 months; according to criteria in DSM IV)
>2 major depressive episodesin past 5 years
recency of last episode < 2years
currently not using any anti-depressant medication (>4 weeks)
- Exclusion criteriacurrent major depressive episode
current use of anti-depressant medication
neurological problems
drug abuse
use of psychotropic medication other than frequent use of benzodiazepine anu other current DSM IV Axis-I diagnosis, as objectified with the SCID-I
MRI contra indications
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2015
- planned closingdate1-feb-2019
- Target number of participants100
- InterventionsProtocolised Preventive Cognitive Therapy
- Primary outcomeTesting whether preventive cognitive therapy in remitted patients results in increased prefrontal control and whether this increased prefrontal control results in a decrease in attentional biases and increase in emotion regulation capacity.
- Secondary outcomePredict individual treatment succes in remitted depressed patients based on neurocognitive measures. Translate neurocognitive principles to clinically usefull measures to predict and monitor individual preventive cognitive therapy success.
- TimepointsScreening: with the SCID-I, the IDS-SR , the DART
First phase: Questionnaires, computer tasks, fMRI-scan
Second phase: Preventive cognitive therapy (8x 45 mins)
Third phase: 3 months after 1st phase, similar as 1st phase.
Fourth phase: questionnaires, 1,5 year after 1st phase,
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.J. van Tol
- CONTACT for SCIENTIFIC QUERIES M.J. van Tol
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
NWO VENI grant 016.156.077, Hersenstichting Nederland, Fellowship F2014(1)-21
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-aug-2015 - 26-aug-2015


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