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

NCT ID: NCT05385614

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-06-30

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.

Conditions

Depression; Cognitive Impairment; Cognitive Dysfunction; Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Control

Control group that will receive the app after primary endpoint was assessed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Experimental group that will receive the app at the start of their participation

Group Type: EXPERIMENTAL

de:)press

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Fallgatter, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Simone Weller, M.Sc.

Role: CONTACT

simone.weller@med.uni-tuebingen.de

07071 29-80815

Facility Contacts

Simone Weller, M.Sc.

Role: primary

simone.weller@med.uni-tuebingen.de

07071 29-8015

Other Identifiers

950/2021BO2

Identifier Type: -

Identifier Source: org_study_id