Augmentation of Depression Treatment by Gamified Network Retraining
Primary Purpose
Depression Mild, Cognitive Impairment, Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Usability of the CCT
Changes in regards to the depressive disorder
Sponsored by

About this trial
This is an interventional other trial for Depression Mild
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry and Psychotherapy, University of Tübingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CCT (standard)
CCT (game)
Arm Description
This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.
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.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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).
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).
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).
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).
Full Information
NCT ID
NCT04400162
First Posted
January 9, 2020
Last Updated
April 27, 2021
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04400162
Brief Title
Augmentation of Depression Treatment by Gamified Network Retraining
Official Title
Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
March 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Cognitive Impairment, Cognitive Dysfunction, Depressive Disorder, Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCT (standard)
Arm Type
Active Comparator
Arm Description
This arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements.
Arm Title
CCT (game)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usability of the CCT
Intervention Description
Evaluation of the usability of the provided training.
Intervention Type
Behavioral
Intervention Name(s)
Changes in regards to the depressive disorder
Intervention Description
Evaluation of depressive symptoms and whether they change in regards to the provided training.
Primary Outcome Measure Information:
Title
Usability and feasibility on the UsExQ [User Experience Questionnaire]
Description
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).
Time Frame
2-4 weeks
Title
MADRS [Montgomery-Asberg Depression Rating Scale]
Description
Evaluation of depressive symptoms over the course of the intervention on the MADRS (lower numberes show decrease in depressive symptoms; range from 0-60).
Time Frame
18-20 weeks
Secondary Outcome Measure Information:
Title
WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)
Description
Changes of the score over the course of the experiment (lower numbers showing decrease of perceived wellbeing; range from 0-25).
Time Frame
18-20 weeks
Title
IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)
Description
Changes of the score over the course of the experiment (lower numbers showing decrease of symptoms; range from 0-84).
Time Frame
18-20 weeks
Title
RSES [Rosenberg Self Esteem Scale] (self esteem)
Description
Changes of the score over the course of the experiment (higher scores showing increase of self-esteem; range from 0-30).
Time Frame
18-20 weeks
Title
SRQ [State Rumination Questionnaire] (rumination)
Description
Changes of the score over the course of the experiment (lower scores showing decrease of ruminating thoughts; range from 10-50).
Time Frame
18-20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Plewnia, MD
Organizational Affiliation
University Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36339520
Citation
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.
Results Reference
derived
Learn more about this trial
Augmentation of Depression Treatment by Gamified Network Retraining
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