Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual

Conditions
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Depression, Cognitive Impairment, Cognitive Dysfunction, Depressive Disorder

Intervention / Treatment
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* Behavioral: de:)press


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, female, diverse, age >= 18, informed consent, sufficient understanding of German (native speaker or CEFR level B skills or higher), unipolar depression diagnosed according to ICD-10 (F32.0, F32.1, F32.2 or F33. 0, F32.1, F32.2). consultation with a physician due to depressive symptomatology within the last 6 months Exclusion Criteria: Inability to give consent, inability to use de:)press® on a tablet or smartphone, acute suicidality, schizophrenia (F20), brief psychotic disorder (F23), schizoaffective disorder (F25), mental disorders due to known physiological conditions (F00 - F09), major depressive disorder, single episode, severe with psychotic features (F32.3), major depressive disorder, recurrent, severe with psychotic features (F33.3), Intellectual disability (F70 - F79).

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group that will receive the app after primary endpoint was assessed. | |
| Experimental: Intervention<br>Experimental group that will receive the app at the start of their participation | Behavioral: de:)press<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS | Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate (MADRS ≤ 50%) at the final examination. | 10 weeks | 
| Remission rate | MADRS score ≤ 10. | 10 weeks | 
| 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 |