An interventional study of Usability of the CCT and Changes in regards to the depressive disorder in Depression Mild, Cognitive Impairment and Cognitive Dysfunction, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Other
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.
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 32 is below the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.
Behavioral: Usability of the CCT · Behavioral: Changes in regards to the depressive disorder
This arm consists of the same CCT as the standard version, however pre-defined gaming elements that are thought to increase usability as well as interest in the intervention have been added.
Behavioral: Usability of the CCT · Behavioral: Changes in regards to the depressive disorder
Evaluation of the usability of the provided training.
Evaluation of depressive symptoms and whether they change in regards to the provided training.
Usability and feasibility on the UsExQ [User Experience Questionnaire]
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).
Time frame: 2-4 weeks
MADRS [Montgomery-Asberg Depression Rating Scale]
Evaluation of depressive symptoms over the course of the intervention on the MADRS (lower numberes show decrease in depressive symptoms; range from 0-60).
Time frame: 18-20 weeks
WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)
Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).
Time frame: 18-20 weeks
IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)
Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).
Time frame: 18-20 weeks
RSES [Rosenberg Self Esteem Scale] (self esteem)
Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).
Time frame: 18-20 weeks
SRQ [State Rumination Questionnaire] (rumination)
Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).
Time frame: 18-20 weeks
Plan to share: Undecided
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Tuebingen