Clinical trial NCT05385614: Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual
Official title: Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Cognitive Impairment
Cognitive Dysfunction
Depressive Disorder
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: MADRS
timeFrame: 10 weeks
Secondary outcomes:
measure: Response rate
timeFrame: 10 weeks
measure: Remission rate
timeFrame: 10 weeks
measure: IDS-SR reduction
timeFrame: 10 weeks
measure: WHO-5 changes
timeFrame: 10 weeks
measure: WPAI changes
timeFrame: 10 weeks
measure: Training sessions
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 10 weeks
measure: Self-esteem
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tübingen
name: Andreas Fallgatter, Prof.
role: PRINCIPAL_INVESTIGATOR
References: