Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depressive Disorder
- Therapy Resistant Depression
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The interventional study consists of two parallel study arms. The interventional group receives "treatment-as-usual" with nasal esketamine spray and access to edupression.com®. The control group only receives "treatment-as-usual".Masking: Single (Participant)Masking Description: Data will be immediately pseudonymized and stored as a master list at the internal server of the MUV (Medical University Vienna). The study staff will only have access to the master list and only the principal investigator and study director will have access to the pseudonymization list. This locked place will be located at the clinic (MUV). All non-personal pseudonymized research relevant data are stored in a master list on a server of the research group at the MUV, to which study staff has access.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
edupression.com® - is a medical product and computer based self-help program based on cognitive behavioral therapy, psychoeducation and mood tracking. Patients included in the interventional arm of this study are receiving full access to edupression.com®. Due to limited resources regarding face-to-f...
edupression.com® - is a medical product and computer based self-help program based on cognitive behavioral therapy, psychoeducation and mood tracking. Patients included in the interventional arm of this study are receiving full access to edupression.com®. Due to limited resources regarding face-to-face therapy and a high prevalence of Major Depressive Disorder - of which 37% can be identified as therapy-resistant depression (TRD) according to the definition of the European Medical Agency (EMA) - low-intensity psychosocial interventions such as edupression.com® are recommended as first-line digital therapeutic agent by international guidelines such as National Institute for Health and Care Excellence (NICE) guidelines. Studies have shown that digital interventions - such as edupression.com - show comparable clinical efficiency to face-to-face therapy and therefore could be able to fill the gap in limited ressources. In this study patients with therapy-resistant depression are receiving therapy with edupression.com® in addition to their treatment-as-usual with esketamine nasal spray. Comparable studies have shown that patients receiving psychotherapy in addition to their medical therapy benefit in regards to their clinical outcome. Considering these findings, this study is aimed to investigate potential clinical benefits in patients receiving digital therapy with edupression®.com as an add-on therapy to their treatment-as-usual therapy with esketamine nasal spray.
Tracking Information
- NCT #
- NCT04843462
- Collaborators
- Not Provided
- Investigators
- Study Chair: Markus Dold, MD., Priv.Doz. Medical University of Vienna Study Chair: Gabriele Fischer, MD, Prof. Medical University of Vienna Principal Investigator: Lukas M Pezawas, MD, Prof. Medical University of Vienna
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