Augmentation of Depression Treatment by Gamified Network Retraining

Study Overview
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Brief Summary
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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.

Official Title
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Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience

Conditions
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Depression Mild, Cognitive Impairment, Cognitive Dysfunction, Depressive Disorder, Depression

Intervention / Treatment
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* Behavioral: Usability of the CCT
* Behavioral: Changes in regards to the depressive disorder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCT (standard)<br>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<br>* Evaluation of the usability of the provided training.<br>Behavioral: Changes in regards to the depressive disorder<br>* Evaluation of depressive symptoms and whether they change in regards to the provided training.<br>|
| Experimental: CCT (game)<br>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<br>* Evaluation of the usability of the provided training.<br>Behavioral: Changes in regards to the depressive disorder<br>* Evaluation of depressive symptoms and whether they change in regards to the provided training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 18-20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 18-20 weeks |