Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray
NCT ID: NCT04843462
Last Updated: 2022-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2021-04-29
2023-04-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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edupression.com® + treatment-as-usual
Patients are receiving treatment with edupression.com® in addition to TAU (treatment-as-usual) with esketamine nasal spray
edupression.com®
Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly.
It can be used on a PC as well as on mobile devices (browser, app) at any time.
Esketamine nasal spray
All patients included in this study are receiving esketamine nasal spray as treatment-as-usual
treatment-as-usual
Patients are receiving TAU (treatment-as-usual) with esketamine nasal spray
Esketamine nasal spray
All patients included in this study are receiving esketamine nasal spray as treatment-as-usual
Interventions
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edupression.com®
Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly.
It can be used on a PC as well as on mobile devices (browser, app) at any time.
Esketamine nasal spray
All patients included in this study are receiving esketamine nasal spray as treatment-as-usual
Eligibility Criteria
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Inclusion Criteria
* Initial MADRS-Score of 22 or above
* Diagnosis of a therapy-resistant depression following the definition of the European Medicines Agency (EMA) - absence of remission after two or more guideline-oriented therapies
* Patients assigned to treatment with nasal esketamine spray Spravato®
* Signed informed consent
* Native German speaker
* Basic knowledge in using computers/smartphones operationalized as daily use of at least two devices (such as tablets, computers, smartphones etc)
Exclusion Criteria
* Diagnosis of one of the following psychiatric comorbidities: substance abuse, schizoaffective disorders, schizophrenia, bipolar disorder, organic disorders diagnosed via Mini International Neuropsychiatric Interview (MINI)
18 Years
ALL
No
Sponsors
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Lukas Pezawas
OTHER
Responsible Party
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Lukas Pezawas
Assoc.Prof. Priv.Doz. Dr. Lukas Pezawas
Principal Investigators
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Markus Dold, MD., Priv.Doz.
Role: STUDY_CHAIR
Medical University of Vienna
Gabriele Fischer, MD, Prof.
Role: STUDY_CHAIR
Medical University of Vienna
Lukas M Pezawas, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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National Collaborating Centre for Mental Health (UK). Depression: The Treatment and Management of Depression in Adults (Updated Edition). Leicester (UK): British Psychological Society; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK63748/
Luo C, Sanger N, Singhal N, Pattrick K, Shams I, Shahid H, Hoang P, Schmidt J, Lee J, Haber S, Puckering M, Buchanan N, Lee P, Ng K, Sun S, Kheyson S, Chung DC, Sanger S, Thabane L, Samaan Z. A comparison of electronically-delivered and face to face cognitive behavioural therapies in depressive disorders: A systematic review and meta-analysis. EClinicalMedicine. 2020 Jun 27;24:100442. doi: 10.1016/j.eclinm.2020.100442. eCollection 2020 Jul.
Other Identifiers
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2467/2020
Identifier Type: -
Identifier Source: org_study_id
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