Augmentation of Depression Treatment by Gamified Network Retraining

NCT ID: NCT04400162

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-14

Study Completion Date

2021-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Mild Cognitive Impairment Cognitive Dysfunction Depressive Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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CCT (standard)

This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.

Group Type ACTIVE_COMPARATOR

Usability of the CCT

Intervention Type BEHAVIORAL

Evaluation of the usability of the provided training.

Changes in regards to the depressive disorder

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Usability of the CCT

Intervention Type BEHAVIORAL

Evaluation of the usability of the provided training.

Changes in regards to the depressive disorder

Intervention Type BEHAVIORAL

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

Interventions

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Usability of the CCT

Evaluation of the usability of the provided training.

Intervention Type BEHAVIORAL

Changes in regards to the depressive disorder

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Christian Plewnia, MD

Doctor of Psychiatry and Psychotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Plewnia, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

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Department of Psychiatry and Psychotherapy, University of Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Weller S, Schroeder PA, Plewnia C. Gamification improves antidepressant effects of cognitive control training-A pilot trial. Front Digit Health. 2022 Oct 21;4:994484. doi: 10.3389/fdgth.2022.994484. eCollection 2022.

Reference Type DERIVED
PMID: 36339520 (View on PubMed)

Other Identifiers

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248/2019BO1

Identifier Type: -

Identifier Source: org_study_id

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