ClinicalTrials.Veeva

Menu

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

U

University Hospital Tuebingen

Status

Unknown

Conditions

Cognitive Impairment
Cognitive Dysfunction
Depression
Depressive Disorder

Treatments

Behavioral: de:)press

Study type

Interventional

Funder types

Other

Identifiers

NCT05385614
950/2021BO2

Details and patient eligibility

About

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.

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

112 participants in 2 patient groups

Control
No Intervention group
Description:
Control group that will receive the app after primary endpoint was assessed.
Intervention
Experimental group
Description:
Experimental group that will receive the app at the start of their participation
Treatment:
Behavioral: de:)press

Trial contacts and locations

1

Loading...

Central trial contact

Simone Weller, M.Sc.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems