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| Name | Class |
|---|---|
| Hospital del Mar Research Institute (IMIM) | OTHER |
| Research Centre of the German Foundation for Depression and Suicide Prevention | UNKNOWN |
| Monsenso | INDUSTRY |
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The purpose of the MENTINA trial is to investigate the effect of using the smartphone-based MENTINA app for self-monitoring of depressive symptoms and rule-based feedback in individuals with current or previous depression, psychological vulnerability, and increased risk of depression in a randomized controlled trial (RCT) over a 12-month trial period. The aim is to potentially offer the MENTINA app as a self-management tool for individuals with psychological vulnerability and/or depressive symptoms or episodes.
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:
Exclusion criteria:
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.
The intervention in the MENTINA trial consist of a smartphone app, which allows for daily monitoirng of symptoms such as mood, sleep, activity etc. Also, a library with content concerning depressive symptoms will be available.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone-based self-monitoring and rule-based feedback | Experimental | 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 |
|
| Control | Placebo Comparator | The app is installed for outcome measures, but no access to the content of the app is provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The MENTINA app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire 9 items (PHQ-9) | Differences between the intervention group and the control group in the total Patient Health Questionnaire 9 items (PHQ-9) score performed every 14th day during the 12-months trial period. | From enrollment and during the study period of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Differences between the intervention group and the control group in the level of quality of life according to the WHO Quality of life BREF16 (WHO QoL) | From enrollmetn to end of treatment af 12 months |
| Generalized Anxiety Disorder 7 items scale (GAD-7) |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the app: System Usability Scale (SUS) | Usability of the app: System Usability Scale (SUS) | From baseline and during the study period |
| Perceived usefulness for patient-clinician communication |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Copenhagen | Frederiksberg | 2000 | Denmark | |||
| Frankfurt University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41638726 | Derived | Faurholt-Jepsen M, Dyreholt MS, Kyster NB, Iversen N, Kortsen EM, Amann BL, Hogg B, Gatto D, Cordoba C, Petrovic M, Allenhof C, Schnitzspahn K, Reich H, Budtz-Jorgensen E, Kessing LV, Hegerl U. Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial. BMJ Open. 2026 Feb 4;16(2):e115773. doi: 10.1136/bmjopen-2025-115773. |
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Sensitive data that cannot be anonymised completely.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Monsenso A/S as sponsor |
| UNKNOWN |
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| Control | Other | The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done. |
|
Differences between the intervention group and the control group in the level of anxiety symptoms according to the Generalized Anxiety Disorder scale (GAD-7) |
| From enrollment to end of treatment at 12 months |
| PHQ-9 |
| From baseline and during the 12 months study period |
| Perceived Stress Scale (PSS) | Differences between the group | From baseline and during the 12 months study period |
| User-reported healthcare contacts | Number of healthcare contact during the study | From baseline and during the 12 months study period |
| Negative effects: Negative Effects Questionnaire (NEQ) | Differences between the two groups | Form baseline and during the 12 months study period |
| PHQ-9 |
| From baseline and during the 12 months study period |
Qualitative interviews
| From baseline and during the trial period |
| Interviews with participants and clinicians/psychotherapists | Qualitative interviews on an subsample | From baseline and during the trial period |
| Frankfurt |
| Germany |
| Hospital del Mar | Barcelona | Spain |