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Smartphone based Monitoring and cognition Modification Against Recurrence of Depression

Smartphone based Monitoring and cognition Modification Against Recurrence of Depression - SMARD

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47013
Enrollment
224
Registered
2017-01-23
Start date
2017-04-13
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Major Depressive Disorder recurrent type

Interventions

A&B. none
C, D, E. CCT (21 sessions of the Paced Auditory Serial Addition Task (PASAT)
1/day), sham CCT (21 sessions of the Peripheral Visual Training (PVT), ABM (42 sessions 2/day
positive bias training) or sham ABM (42 sessions 2/day
no bias training), or MBT (21 days, 8 prompts/day
in 5x participants will be asked to recall, evaluate and describe a recent positive event) or sham MBT (21 days, 8 prompts/day
in 5x participants will be asked to describe and evaluate their current location).

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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) =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

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 - Claustrophobia - A history of head trauma or neurological disease, severe general physical illness

Design outcomes

Secondary

MeasureTime frame
B, E. Changes in ESM-based symptom-networks; C, D. Drop-out/noncompliance (

Primary

MeasureTime frame
A. Saturation of ideas obtained in the focus-groups; B, E. SCID-+ve recurrences of depression during follow-up; C, D. Changes in PASAT, Visual Probe and Recall/Evaluation task (RET) performance

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)