NCT05385614

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

May 17, 2022

Last Update Submit

May 17, 2022

Conditions

DepressionCognitive ImpairmentCognitive DysfunctionDepressive Disorder

Outcome Measures

Primary Outcomes (1)

  • MADRS

    Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination.

    10 weeks

Secondary Outcomes (8)

  • Response rate

    10 weeks

  • Remission rate

    10 weeks

  • IDS-SR reduction

    10 weeks

  • WHO-5 changes

    10 weeks

  • WPAI changes

    10 weeks

  • +3 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Behavioral: de:)press

Interventions

de:)pressBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

DepressionCognitive DysfunctionDepressive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorCognition DisordersNeurocognitive DisordersMental DisordersMood Disorders

Study Officials

  • Andreas Fallgatter, Prof.

    University Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Weller, M.Sc.

CONTACT

07071 29-80815simone.weller@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 23, 2022

Study Start

May 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

DE(1)