Augmentation of Depression Treatment by Gamified Network Retraining
- Conditions
- Depressive DisorderDepression MildCognitive DysfunctionDepressionCognitive Impairment
- Registration Number
- NCT04400162
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
Major depressive disorder (MDD) is a highly prevalent and debilitating mental disorder with a high lifetime prevalence of 16-20%. Particularly for people with low socio-economic status, the existing and effective treatment options are hard to reach and show weaker effectivities. There is a potential to ameliorate depressive symptoms and improve quality of life in persons with mild-to-moderate depression by providing access to stimulating computerized trainings. Single computerized trainings that target depressive symptoms have been tested in laboratory and clinical settings so far. To date, innovative market access and confirmatory studies are missing for a large-scale implementation of such trainings. Thereby, the present work will foster a digitalized training paradigm (Paced-Auditory Serial Addition Task; PASAT) which was previously shown to reduce depressive symptoms, but in a novel innovative and gamified form on a tablet-PC handed out to participants. Different versions of the same training paradigm that comprise additional game elements will be compared. The feasibility study will gather data on effect size estimates of symptom severity reduction, user experience and usage in an ecological valid setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Full age (> 18 years old)
- Consent
- German mother tongue
- Presence of mild-to-moderate depressive symptoms (MADRS > 10 and < 34 and confirmation of depressive symptoms in M.I.N.I. diagnostic interview)
- Stable or no medication with antidepressant drugs or other psychoactive agents (at least for 6 weeks)
- No or current psychotherapy
- Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
- Cognitive impairment
- Epilepsy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Usability and feasibility on the UsExQ [User Experience Questionnaire] 2-4 weeks Usage frequency, performed calculations during each session and over the course of the participation. Feedback on perceived quality of the device and software. Acceptance of training and willingness to continue (open text questionnaires; usability ranging from -- to ++ on a 5 point scale with negative responses corresponding to a more negative user experience).
MADRS [Montgomery-Asberg Depression Rating Scale] 18-20 weeks Evaluation of depressive symptoms over the course of the intervention on the MADRS (lower numberes show decrease in depressive symptoms; range from 0-60).
- Secondary Outcome Measures
Name Time Method IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression) 18-20 weeks Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).
RSES [Rosenberg Self Esteem Scale] (self esteem) 18-20 weeks Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).
WHO-5 [WHO-Five Well-Being Index] (overall wellbeing) 18-20 weeks Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).
SRQ [State Rumination Questionnaire] (rumination) 18-20 weeks Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).
Trial Locations
- Locations (1)
Department of Psychiatry and Psychotherapy, University of Tübingen
🇩🇪Tübingen, Germany
Department of Psychiatry and Psychotherapy, University of Tübingen🇩🇪Tübingen, Germany