Major Depressive Disorder, Therapy Resistant Depression
Conditions
Keywords
Depression, Esketamine, Treatment resistant depression, Internet-based intervention, Telemedicine
Brief summary
Pragmatic clinical trial of an add-on therapy regarding the use of edupression.com® - a licensed computer based self-help program - on patients with therapy-resistant depression receiving esketamine nasal spray
Detailed 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-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.
Interventions
DEVICEedupression.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.
All patients included in this study are receiving esketamine nasal spray as treatment-as-usual
Sponsors
Lukas Pezawas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * 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
* Contraindication regarding the use of Spravato® * Diagnosis of one of the following psychiatric comorbidities: substance abuse, schizoaffective disorders, schizophrenia, bipolar disorder, organic disorders diagnosed via Mini International Neuropsychiatric Interview (MINI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapy response (observer-rated) | At week 4, 8 and 12 after baseline | Change in depressive symptoms according to MADRS-Score (0-60 points, higher values stand for) |
| Percentage of received esketamine treatments in relation to scheduled ones | Percentage of received esketamine treatments in relation to scheduled ones after 12 weeks | Change in therapy adherence according to a percentual increase of received esketamine treatments in accordance to scheduled ones |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapy response (self-rated) | At week 4, 8 and 12 after baseline | Change in depressive symptoms according to the self rating scale PHQ-9 (Patient Health Questionnaire-9) (1-27 points, higher values stand for increased severity) |
Countries
Austria
Contacts
Primary ContactLukas M Pezawas, MD, Prof.
Backup ContactGabriele Fischer, MD, Prof.
Outcome results
None listed