Depression MildNCT04400162
Augmentation of Depression Treatment by Gamified Network Retraining
A study testing Usability of the CCT and Changes in regards to the depressive disorder in people with Depression Mild and Cognitive Impairment, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Mild, Cognitive Impairment, Cognitive Dysfunction
- What is being tested?
- Usability of the CCT and Changes in regards to the depressive disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 14 May 2020to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
- Cognitive impairment
- Epilepsy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Tübingen
Tübingen, 72076
About this study
Official title: 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.
- Conditions
- Depression Mild, Cognitive Impairment, Cognitive Dysfunction, Depressive Disorder, Depression
- Being tested
- Usability of the CCT, Changes in regards to the depressive disorder
- Medical subject headings
- Cognitive Dysfunction, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability of the CCTBehavioural
Evaluation of the usability of the provided training.
Changes in regards to the depressive disorderBehavioural
Evaluation of depressive symptoms and whether they change in regards to the provided training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usability of the CCT; Behavioral: Changes in regards to the depressive disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 18-20 weeks
Secondary outcomes (4)
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).
Measured: 18-20 weeks
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).
Measured: 18-20 weeks
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).
Measured: 18-20 weeks
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).
Measured: 18-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start14 May 2020
- Primary completion31 Dec 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression MildStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Plewnia, MD, University Hospital Tuebingen
- Investigators
- Christian Plewnia, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400162
- Sponsor's protocol ID
- 248/2019BO1
- Status last verified
- Apr 2021
- First submitted
- 9 Jan 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36339520
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Depression Treatment by Gamified Network Retraining: Feasibility, Effect Size Estimates, and User Experience
- ClinicalTrials.gov ID
- NCT04400162
- Acronym / sponsor ID
- 248/2019BO1
- Conditions
- Depression Mild, Cognitive Impairment, Cognitive Dysfunction, Depressive Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCT (standard) | Active comparator | Behavioral: Usability of the CCT, Behavioral: Changes in regards to the depressive disorderThis arm consists of the CCT in a standard variant that provides the basic training experience without any added gaming elements. |
| CCT (game) | Experimental | Behavioral: Usability of the CCT, Behavioral: Changes in regards to the depressive disorderThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Presence of schizophrenia / psychotic disorder (according to M.I.N.I. diagnostic interview)
- Cognitive impairment
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usability of the CCTEvaluation of the usability of the provided training. | Behavioural | CCT (game), CCT (standard) |
| Changes in regards to the depressive disorderEvaluation of depressive symptoms and whether they change in regards to the provided training. | Behavioural | CCT (game), CCT (standard) |
Primary outcome
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).
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).
4 secondary outcomes
WHO-5 [WHO-Five Well-Being Index] (overall wellbeing)
Time frame: 18-20 weeks
IDS-SR [Inventory of Depressive Symptomatology - Self Report] (depression)
Time frame: 18-20 weeks
RSES [Rosenberg Self Esteem Scale] (self esteem)
Time frame: 18-20 weeks
SRQ [State Rumination Questionnaire] (rumination)
Time frame: 18-20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 36339520Weller 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.
- Individual participant dataSharing planned: Undecided
Related trials for Depression Mild
RecruitingPhase 2
Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
Working Memory, Mild to Moderate Depression
Active, not recruiting
Feasibility and Acceptability of Peer Intervention for Improving Mental Health Among People Accessing Hormone Care
Hormone Care, Mild Depression
Recruiting
GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression
Depression, Depression Disorder
Recruiting
Social Prescribing for a Mindful Lifestyle
Depression and/or Anxiety in the Mild-to-moderate Range, Loneliness
Active, not recruitingObservational study
Health Surveillance at Constructor University Bremen (CUB)
Social Isolation or Loneliness, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Plewnia, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usability of the CCT and Changes in regards to the depressive disorder in people with Depression Mild and Cognitive Impairment, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability and feasibility on the UsExQ [User Experience Questionnaire] (time frame: 2-4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.