Depressionde-press-2NCT05385614
Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual
A study testing de:)press in people with Depression and Cognitive Impairment, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Cognitive Impairment, Cognitive Dysfunction
- What is being tested?
- de:)press
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- May 2022to Jun 2023
- 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
- Male, female, diverse,
- age >= 18,
- informed consent,
- sufficient understanding of German (native speaker or CEFR level B skills or higher),
- unipolar depression diagnosed according to ICD-10 (F32.0, F32.1, F32.2 or F33. 0, F32.1, F32.2).
- consultation with a physician due to depressive symptomatology within the last 6 months
Who cannot join
- Inability to give consent,
- inability to use de:)press® on a tablet or smartphone,
- acute suicidality,
- schizophrenia (F20),
- brief psychotic disorder (F23),
- schizoaffective disorder (F25),
Show all 10Show fewer
- mental disorders due to known physiological conditions (F00 - F09),
- major depressive disorder, single episode, severe with psychotic features (F32.3),
- major depressive disorder, recurrent, severe with psychotic features (F33.3),
- Intellectual disability (F70 - F79).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
Simone Weller, M.Sc., 07071 29-8015, simone.weller@med.uni-tuebingen.de
About this study
Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.
- Being tested
- de:)press
- Medical subject headings
- Depression, Cognitive Dysfunction, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
de:)pressBehavioural
Patients will receive de:)press for the duration of six weeks. They will be encourages to use the app at least three times a week, up to once per day.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group that will receive the app after primary endpoint was assessed. |
| Intervention | Experimental | Experimental group that will receive the app at the start of their participation Receives: Behavioral: de:)press |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination.
Measured: 10 weeks
Secondary outcomes (8)
Response rate
Response rate (MADRS ≤ 50%) at the final examination.
Measured: 10 weeks
Remission rate
MADRS score ≤ 10.
Measured: 10 weeks
IDS-SR reduction
Reduction (IG vs. CG) of IDS-SR score during treatment phase and at final examination.
Measured: 10 weeks
WHO-5 changes
Changes of well-being according to WHO-5 during treatment period and at final examination.
Measured: 10 weeks
WPAI changes
Changes of functionality according to WPAI during treatment period and at final examination.
Measured: 10 weeks
Training sessions
Number of completed training sessions in IG.
Measured: 6 weeks
Adverse events
Adverse events.
Measured: 10 weeks
Self-esteem
Influence of RSES on the primary endpoint.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study startMay 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Fallgatter, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385614
- Sponsor's protocol ID
- 950/2021BO2
- Acronym
- de-press-2
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual
- ClinicalTrials.gov ID
- NCT05385614
- Acronym / sponsor ID
- de-press-2 / 950/2021BO2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 May 2022 (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.
Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group that will receive the app after primary endpoint was assessed. |
| Intervention | Experimental | Behavioral: de:)pressExperimental group that will receive the app at the start of their participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male, female, diverse,
- age >= 18,
- informed consent,
- sufficient understanding of German (native speaker or CEFR level B skills or higher),
- unipolar depression diagnosed according to ICD-10 (F32.0, F32.1, F32.2 or F33. 0, F32.1, F32.2).
Key exclusion criteria (10 listed)
- Inability to give consent,
- inability to use de:)press® on a tablet or smartphone,
- acute suicidality,
- schizophrenia (F20),
- brief psychotic disorder (F23),
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 |
|---|---|---|
| de:)pressPatients will receive de:)press for the duration of six weeks. They will be encourages to use the app at least three times a week, up to once per day. | Behavioural | Intervention |
Primary outcome
MADRS
Time frame: 10 weeks
Difference in symptom severity-reduction (MADRS) between IG and CG at the final examination.
8 secondary outcomes
Response rate
Time frame: 10 weeks
Remission rate
Time frame: 10 weeks
IDS-SR reduction
Time frame: 10 weeks
WHO-5 changes
Time frame: 10 weeks
WPAI changes
Time frame: 10 weeks
Training sessions
Time frame: 6 weeks
Adverse events
Time frame: 10 weeks
Self-esteem
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Fallgatter, Prof. 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 de:)press in people with Depression 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 10 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: status not confirmed, as of the sponsor's last update on 23 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Weller, M.Sc. (07071 29-80815, simone.weller@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.