Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual (de-press-2)

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Depression; Cognitive Impairment; Cognitive Dysfunction
• Intervention / Treatment: Behavioral: de:)press

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone Weller, M.Sc.; Phone Number: 07071 29-80815; Email: simone.weller@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • University Hospital Tübingen
      • Contact: Simone Weller, M.Sc.; Phone Number: 07071 29-8015; Email: simone.weller@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group that will receive the app after primary endpoint was assessed.
Experimental: Intervention; Experimental group that will receive the app at the start of their participation	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Andreas Fallgatter, Prof., University Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Depressive Disorder; Cognitive Dysfunction
• Other Study ID Numbers: 950/2021BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No