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

Depression Clinical Trial

— de-press-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385614
• Other study ID #: 950/2021BO2
• Status: Recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: University Hospital Tuebingen
• Contact: Simone Weller, M.Sc.
• Phone: 07071 29-80815
• Email: simone.weller[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Depressive Disorder

Intervention

Behavioral:
• de:)press
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.

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS	Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination.	10 weeks
Secondary	Response rate	Response rate (MADRS = 50%) at the final examination.	10 weeks
Secondary	Remission rate	MADRS score = 10.	10 weeks
Secondary	IDS-SR reduction	Reduction (IG vs. CG) of IDS-SR score during treatment phase and at final examination.	10 weeks
Secondary	WHO-5 changes	Changes of well-being according to WHO-5 during treatment period and at final examination.	10 weeks
Secondary	WPAI changes	Changes of functionality according to WPAI during treatment period and at final examination.	10 weeks
Secondary	Training sessions	Number of completed training sessions in IG.	6 weeks
Secondary	Adverse events	Adverse events.	10 weeks
Secondary	Self-esteem	Influence of RSES on the primary endpoint.	10 weeks