Augmentation of Depression Treatment by Gamified Network Retraining

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400162
• Other study ID #: 248/2019BO1
• Status: Completed
• Phase: N/A
• Start date: May 14, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: April 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Depression Mild
• Depressive Disorder

Intervention

Behavioral:
• Usability of the CCT
Evaluation of the usability of the provided training.
• Changes in regards to the depressive disorder
Evaluation of depressive symptoms and whether they change in regards to the provided training.

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)	Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).	18-20 weeks
Secondary	IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)	Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).	18-20 weeks
Secondary	RSES [Rosenberg Self Esteem Scale] (self esteem)	Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).	18-20 weeks
Secondary	SRQ [State Rumination Questionnaire] (rumination)	Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).	18-20 weeks