NL-OMON47013
Recruiting
Phase 2
Smartphone based Monitoring and cognition Modification Against Recurrence of Depression - SMARD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 224
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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