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Completed

NCT Number: NCT04400162

Augmentation of Depression Treatment by Gamified Network Retraining

Major depressive disorder (MDD) is a highly prevalent and debilitating mental disorder with a high lifetime prevalence of 16-20%. Particularly for people with low socio-economic status, the existing and effective treatment options are hard to reach and show weaker effectivities. There is a potential to ameliorate depressive symptoms and improve quality of life in persons with mild-to-moderate depression by providing access to stimulating computerized trainings. Single computerized trainings that target depressive symptoms have been tested in laboratory and clinical settings so far. To date, innovative market access and confirmatory studies are missing for a large-scale implementation of such trainings. Thereby, the present work will foster a digitalized training paradigm (Paced-Auditory Serial Addition Task; PASAT) which was previously shown to reduce depressive symptoms, but in a novel innovative and gamified form on a tablet-PC handed out to participants. Different versions of the same training paradigm that comprise additional game elements will be compared. The feasibility study will gather data on effect size estimates of symptom severity reduction, user experience and usage in an ecological valid setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, University of Tübingen

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full age (> 18 years old)
  • Consent
  • German mother tongue
  • Presence of mild-to-moderate depressive symptoms (MADRS > 10 and < 34 and confirmation of depressive symptoms in M.I.N.I. diagnostic interview)
  • Stable or no medication with antidepressant drugs or other psychoactive agents (at least for 6 weeks)
  • No or current psychotherapy

Exclusion criteria

  • Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
  • Cognitive impairment
  • Epilepsy

Treatment and study plan

Usability of the CCT

Behavioral

Evaluation of the usability of the provided training.

Changes in regards to the depressive disorder

Behavioral

Evaluation of depressive symptoms and whether they change in regards to the provided training.

Primary outcomes

  1. Usability and feasibility on the UsExQ [User Experience Questionnaire]

    Time frame: 2-4 weeks

    Usage frequency, performed calculations during each session and over the course of the participation. Feedback on perceived quality of the device and software. Acceptance of training and willingness to continue (open text questionnaires; usability ranging from -- to ++ on a 5 point scale with negative responses corresponding to a more negative user experience).

  2. MADRS [Montgomery-Asberg Depression Rating Scale]

    Time frame: 18-20 weeks

    Evaluation of depressive symptoms over the course of the intervention on the MADRS (lower numberes show decrease in depressive symptoms; range from 0-60).

Secondary outcomes

  1. WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)

    Time frame: 18-20 weeks

    Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).

  2. IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)

    Time frame: 18-20 weeks

    Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).

  3. RSES [Rosenberg Self Esteem Scale] (self esteem)

    Time frame: 18-20 weeks

    Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).

  4. SRQ [State Rumination Questionnaire] (rumination)

    Time frame: 18-20 weeks

    Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 22, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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