Augmentation of Depression Treatment by Gamified Network Retraining

April 27, 2021 updated by: Christian Plewnia, MD, University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • Department of Psychiatry and Psychotherapy, University of Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CCT (standard)
This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.
Behavioral: Usability of the CCT
Evaluation of the usability of the provided training.
Behavioral: Changes in regards to the depressive disorder
Evaluation of depressive symptoms and whether they change in regards to the provided training.
Experimental: CCT (game)
This arm consists of the same CCT as the standard version, however pre-defined gaming elements that are thought to increase usability as well as interest in the intervention have been added.
Behavioral: Usability of the CCT
Evaluation of the usability of the provided training.
Behavioral: Changes in regards to the depressive disorder
Evaluation of depressive symptoms and whether they change in regards to the provided training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2-4 weeks
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).
18-20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
18-20 weeks
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).
18-20 weeks
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).
18-20 weeks
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).
18-20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Christian Plewnia, MD, University Hospital Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248/2019BO1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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