Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual
- Conditions
- DepressionCognitive ImpairmentCognitive DysfunctionDepressive Disorder
- Registration Number
- NCT05385614
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MADRS 10 weeks Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination.
- Secondary Outcome Measures
Name Time Method Response rate 10 weeks Response rate (MADRS ≤ 50%) at the final examination.
IDS-SR reduction 10 weeks Reduction (IG vs. CG) of IDS-SR score during treatment phase and at final examination.
WHO-5 changes 10 weeks Changes of well-being according to WHO-5 during treatment period and at final examination.
Remission rate 10 weeks MADRS score ≤ 10.
Self-esteem 10 weeks Influence of RSES on the primary endpoint.
WPAI changes 10 weeks Changes of functionality according to WPAI during treatment period and at final examination.
Training sessions 6 weeks Number of completed training sessions in IG.
Adverse events 10 weeks Adverse events.
Trial Locations
- Locations (1)
University Hospital Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany