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Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group that will receive the app after primary endpoint was assessed. | |
| Intervention | Experimental | Experimental group that will receive the app at the start of their participation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| de:)press | Behavioral | Patients will receive de:)press for the duration of six weeks. They will be encourages to use the app at least three times a week, up to once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MADRS | Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response rate (MADRS ≤ 50%) at the final examination. | 10 weeks |
| Remission rate | MADRS score ≤ 10. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Weller, M.Sc. | Contact | 07071 29-80815 | simone.weller@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Fallgatter, Prof. | University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| IDS-SR reduction | Reduction (IG vs. CG) of IDS-SR score during treatment phase and at final examination. | 10 weeks |
| WHO-5 changes | Changes of well-being according to WHO-5 during treatment period and at final examination. | 10 weeks |
| WPAI changes | Changes of functionality according to WPAI during treatment period and at final examination. | 10 weeks |
| Training sessions | Number of completed training sessions in IG. | 6 weeks |
| Adverse events | Adverse events. | 10 weeks |
| Self-esteem | Influence of RSES on the primary endpoint. | 10 weeks |
| D001523 |
| Mental Disorders |
| D019964 | Mood Disorders |