Smartphone based Monitoring and cognition Modification Against Recurrence of Depression (SMARD) – Workpackage 2

Recruiting

Conditions: (Remitted) Major Depressive Disorder

Registration Number: NL-OMON27513

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1.Age 18-65 years
2.Recurrent MDD diagnoses (according to DSM-IV and SCID)
3.At least 3 previous MDD-episodes (assessed with the SCID-interview)
4.In stable remission: does not meet criteria for a current MDD episode (SCID-interview) =8 weeks and a Hamilton Depression Rating Scale score =10
5.In possession of smartphone and experienced in use thereof

Exclusion Criteria

1.Diagnosis of bipolar, primary psychotic or borderline personality disorder or strong suspicion of this type of disorder
2.Primary diagnosis of substance use or anxiety disorder with secondary MDD
3.Electroconvulsive therapy within two months before inclusion
4.Average alcohol intake of >3 units/day
5.Daily use of benzodiazepines (=5mg diazepam or equivalent)
6.Ongoing psychotherapy during the CCT/ABT/MBT training
7.Previous CCT/AB/MBT training

For the optional add-on MRI-part, standard MRI exclusion criteria will apply.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in attention (PASAT), peripheral attention (PVT), attentional bias and memory bias task performance<br>2.SCID positive recurrences of MDD during an observational follow-up of 1.5 years<br>

Secondary Outcome Measures

Name	Time	Method
1.Validation of three cognitive training modules:<br>•Change in rumination scores (RRS) <br>•Changes in executive neuropsychological functioning<br>•Changes in brain network-connectivity and associated parameters <br>•Drop-out / compliance of CCT, ABT, MBT tasks<br>2.BEHAPP data to be used for identification and prediction of prospective recurrence during an observational follow-up of 1.5 years<br>3.Changes in ESM-based symptom-networks (daily positive and negative affect measurement) and residual symptoms (HDRS17)<br>