Augmentation of Depression Treatment by Gamified Network Retraining

NCT04400162 | Completed

• 1 other identifier: 248/2019BO1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression Mild; Cognitive Impairment; Cognitive Dysfunction; Depressive Disorder; Depression

Outcome Measures

Primary Outcomes (2)

• Usability and feasibility on the UsExQ [User Experience Questionnaire]

  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]

  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 Outcomes (4)

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

  18-20 weeks

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

  18-20 weeks

• RSES [Rosenberg Self Esteem Scale] (self esteem)

  18-20 weeks

• SRQ [State Rumination Questionnaire] (rumination)

  18-20 weeks

Study Arms (2)

CCT (standard)

ACTIVE COMPARATOR

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; Behavioral: Changes in regards to the depressive disorder

CCT (game)

EXPERIMENTAL

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; Behavioral: Changes in regards to the depressive disorder

Interventions

Usability of the CCT BEHAVIORAL

Evaluation of the usability of the provided training.

CCT (game); CCT (standard)

Changes in regards to the depressive disorder BEHAVIORAL

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

CCT (game); CCT (standard)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• 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.

  PMID: 36339520 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Christian Plewnia, MD

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Psychiatry and Psychotherapy

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: May 22, 2020
• Study Start: May 14, 2020
• Primary Completion: December 31, 2020
• Study Completion: March 15, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

DE (1)