Clinical trial NCT04400162: Augmentation of Depression Treatment by Gamified Network Retraining
Official title: Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Mild
Cognitive Impairment
Cognitive Dysfunction
Depressive Disorder
Depression
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
* Cognitive impairment
* Epilepsy

Primary outcomes:
measure: Usability and feasibility on the UsExQ [User Experience Questionnaire]
timeFrame: 2-4 weeks
measure: MADRS [Montgomery-Asberg Depression Rating Scale]
timeFrame: 18-20 weeks
Secondary outcomes:
measure: WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)
timeFrame: 18-20 weeks
measure: IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)
timeFrame: 18-20 weeks
measure: RSES [Rosenberg Self Esteem Scale] (self esteem)
timeFrame: 18-20 weeks
measure: SRQ [State Rumination Questionnaire] (rumination)
timeFrame: 18-20 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Christian Plewnia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weller S, Schroeder PA, Plewnia C. Gamification improves antidepressant effects of cognitive control training-A pilot trial. Front Digit Health. 2022 Oct 21;4:994484. doi: 10.3389/fdgth.2022.994484. eCollection 2022.