Smartphone based Monitoring and cognition Modification Against Recurrence of Depressio
- Conditions
- Major Depressive Disorderrecurrent type10027946
- Registration Number
- NL-OMON47013
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 224
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- recurrent MDD diagnoses (assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) (SCID) [First 1996])
- at least 3 previous MDD-episodes (as assessed with the SCID-interview)
- a 17-item Hamilton Depression Rating Scale (HDRS17) <=10 [Hamilton 1967], not fulfilling the criteria for a current MDD episode (as assessed with the SCID-interview)
- having a stable remission (>=8 weeks)
- age 18-65 years
- in possession of smartphone and experienced in use thereof
For the focus-groups in WP1, assessment of unipolarity, number of recurrences and non-depressed state will be assessed by history only (no SCID/HDRS17) as more thorough assessments are not proportional to the aim of the focus-groups.
For both WPs:
- diagnosis of bipolar, primary psychotic or borderline personality disorder or strong suspicion of this type of disorder
- primary diagnosis of substance use or anxiety disorder with secondary MDD (comorbid secondary anxiety disorder allowed for participation)
- electroconvulsive therapy within two months before inclusion
- average alcohol intake of >3 units/day
- daily use of benzodiazepines (>=5mg diazepam or equivalent)
- Incompatible smartphone to install BeHapp ;Additional exclusion-criteria for WP2:
- ongoing psychotherapy during the CCT/ABM training
- previous CCT/ABM ;For the add-on MRI-part of WP2, standard MRI exclusion criteria will apply:
- Metal objects in the body
- Claustrophobia
- A history of head trauma or neurological disease, severe general physical illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A. Saturation of ideas obtained in the focus-groups;<br /><br>B, E. SCID-+ve recurrences of depression during follow-up;<br /><br>C, D. Changes in PASAT, Visual Probe and Recall/Evaluation task (RET)<br /><br>performance </p><br>
- Secondary Outcome Measures
Name Time Method <p>B, E. Changes in ESM-based symptom-networks;<br /><br>C, D. Drop-out/noncompliance (<80% of training sessions) of CCT, ABM or<br /><br>MBT-tasks; Change in rumination-scores; Change in executive neuropsychological<br /><br>functioning; Changes in brain network-connectivity and associated parameters;<br /><br>E. Association of change in PASAT/PVT/RET performance, negative biases and<br /><br>executive functioning with future recurrences of depression during follow-up<br /><br></p><br>