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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27513
Enrollment
120
Registered
2021-08-12
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Remitted) Major Depressive Disorder

Interventions

Participants are randomized to a CCT (21 sessions of the Paced Auditory Serial Addition Task (PASAT)
1/day) or sham CCT (21 sessions of the Peripheral Visual Training (PVT)
1/day), ABT positive bias training (42 sessions
2/day) or sham ABT (42 sessions 2/day
no bias training), MBT (21 days
8 prompts/day) or sham MBT (21 days
8 prompts/day). Randomization will be done based on a minimization procedure for use of antidepressants and residual symptoms to obtain comparable antidepressant use and mean HDRS 17 scores between gr

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1.Changes in attention (PASAT), peripheral attention (PVT), attentional bias and memory bias task performance 2.SCID positive recurrences of MDD during an observational follow-up of 1.5 years

Secondary

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

Contacts

Public ContactHenricus G. Ruhe

Radboudumc & Donders Institute for Brain, Cognition and Behavior, Radboud University

eric.ruhe@radboudumc.nl+31 6 51508197

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 5, 2026