Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Usability and feasibility on the UsExQ [User Experience Questionnaire]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Full age (> 18 years old)
- •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
Exclusion Criteria
- •Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
- •Cognitive impairment
Outcomes
Primary Outcomes
Usability and feasibility on the UsExQ [User Experience Questionnaire]
Time Frame: 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]
Time Frame: 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 Outcomes
- IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)(18-20 weeks)
- RSES [Rosenberg Self Esteem Scale] (self esteem)(18-20 weeks)
- WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)(18-20 weeks)
- SRQ [State Rumination Questionnaire] (rumination)(18-20 weeks)
Investigators
Christian Plewnia, MD
Doctor of Psychiatry and Psychotherapy
University Hospital Tuebingen