The Effect of Digital Markers in the Self-management of Depressive Symptoms
NCT ID: NCT06919133
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
660 participants
INTERVENTIONAL
2025-05-13
2027-05-01
Brief Summary
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Method and Design:
International, multicenter (three centers), parallel-group, RCT. The active group is assigned the smartphone-based MENTINA app including rule-based data feedback. The control group uses the MENTINA app for questionnaire-based data collection (outcomes) and collection of sensor-based data.
Study Procedures:
The trial will be open-label and unblinded. The trial uses the self-reported Patient Health Questionnaire-9 score (PHQ-9) as the primary outcome measure. Scoring will take place every 14 days over the 12-month trial period. Depressive symptoms during the first 6 months of app use will also be evaluated as secondary outcomes.
Participants, Including Inclusion and Exclusion Criteria A total of 220 individuals will be included from each center (Denmark, Germany, and Spain) with psychological vulnerability (depressive symptoms and possibly previous depressive episodes). A total sample size of 660 participants will be included.
Inclusion criteria:
* Age 18 years or older
* Depressive symptoms, assessed by PHQ-9 \> 8, AND/OR
* Current or previous depressive episode(s) (ICD-10 F32, F33)
* Owns and uses a smartphone
* Signed informed consent to participate
Exclusion criteria:
* ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse
* Current psychotic depression
* Current suicide risk
* Acute somatic illness requiring treatment (intensive care)
* Insufficient language skills in Danish, German or Spanish (depending on site)
Side Effects, Risks, and Disadvantages
Side effects and risks:
We do not expect any serious side effects from using the MENTINA app. Possible side effects could include increased focus on one's own illness, potentially worsening depressive symptoms and suicidal thoughts.
Recruitment of Participants The study population will consist of adults vulnerable to mental health issues, defined by a PHQ-9 score \> 8 or previous depressive symptoms at the time of inclusion. Each study site will be responsible for local recruitment and follow-up.
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Detailed Description
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Rules for feedback based of self-reported measures will be developed. Based on the self-reported measures participants will be suggested to read items from the library or call emergency health care facilities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Smartphone-based self-monitoring and rule-based feedback
The smartphone-based MENTINA app for daily self-monitoring of depressive symptoms and other symptoms + rule-based feedback based on self-monitoried data and sensor data from smartphones
The MENTINA app
A smartphone-based app is developed and used in this trial. The smartphone-based MENTINA app allows for daily self-monitoring of depressive symptoms such as mood, sleep, activity etc and rule-based feedback based on self-monitored data as well as collected sensor data. Libary with relevant content will also be available and incoorporated in the rule-based feedback.
Control
The app is installed for outcome measures, but no access to the content of the app is provided.
Control
The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.
Interventions
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The MENTINA app
A smartphone-based app is developed and used in this trial. The smartphone-based MENTINA app allows for daily self-monitoring of depressive symptoms such as mood, sleep, activity etc and rule-based feedback based on self-monitored data as well as collected sensor data. Libary with relevant content will also be available and incoorporated in the rule-based feedback.
Control
The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.
Eligibility Criteria
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Inclusion Criteria
* Depressive symptoms, assessed by PHQ-9 \> 8, AND/OR
* Current or previous depressive episode(s) (ICD-10 F32, F33)
* Owns and uses a smartphone
* Signed informed consent to participate
Exclusion Criteria
* Current psychotic depression
* Current suicide risk
* Acute somatic illness requiring treatment (intensive care)
* Insufficient language skills in Danish, German or Spanish and english (depending on site)
18 Years
ALL
No
Sponsors
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Hospital del Mar Research Institute (IMIM)
OTHER
Research Centre of the German Foundation for Depression and Suicide Prevention
UNKNOWN
Monsenso
INDUSTRY
Monsenso A/S as sponsor
UNKNOWN
Mental Health Services in the Capital Region, Denmark
OTHER
Responsible Party
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Lars Vedel Kessing
Professor, MD, Dr.Med.
Locations
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Psychiatric Center Copenhagen
Frederiksberg, , Denmark
Frankfurt University Hospital
Frankfurt, , Germany
Hospital del Mar
Barcelona, , Spain
Countries
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Other Identifiers
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101080651
Identifier Type: -
Identifier Source: org_study_id
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