The Effect of Digital Markers in the Self-management of Depressive Symptoms (MENTINA)

January 13, 2026 updated by: Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark

The Effect of Digital Markers in the Self-management of Depressive Symptoms - The MENTINA Randomized Controlled Parallel Group Trial

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:

  • 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 2000
        • Psychiatric Center Copenhagen
  • Germany
      • Frankfurt, Germany
        • Frankfurt University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 and english (depending on site)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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.
Placebo Comparator: Control
The app is installed for outcome measures, but no access to the content of the app is provided.
Other: Control
The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9 items (PHQ-9)
Time Frame: From enrollment and during the study period of 12 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: From enrollmetn to end of treatment af 12 months
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)
Time Frame: From enrollment to end of treatment at 12 months
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
Time Frame: From baseline and during the 12 months study period
  • Monthly change in PHQ-9 scores
  • Response rate defined as the proportion of participants with ≥50% reduction in PHQ-9
  • Remission rate defined as PHQ-9 ≤9 and ≥5-point improvement
  • PHQ-9 scores at 6 months
  • Area Under the Curve (AUC) for PHQ-9 over the trial period

  • Subgroup analysis: differences between the two groups in PHQ-9 analyzed separately for:

    • People with mental distress (without lifetime depression)
    • People with a lifetime diagnosis of depression
From baseline and during the 12 months study period
Perceived Stress Scale (PSS)
Time Frame: From baseline and during the 12 months study period
Differences between the group
From baseline and during the 12 months study period
User-reported healthcare contacts
Time Frame: From baseline and during the 12 months study period
Number of healthcare contact during the study
From baseline and during the 12 months study period
Negative effects: Negative Effects Questionnaire (NEQ)
Time Frame: Form baseline and during the 12 months study period
Differences between the two groups
Form baseline and during the 12 months study period
PHQ-9
Time Frame: From baseline and during the 12 months study period
  • Number of depressive episodes (based on PHQ-9)
  • Duration
  • Number of depression-free days (based on PHQ-9)
From baseline and during the 12 months study period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the app: System Usability Scale (SUS)
Time Frame: From baseline and during the study period
Usability of the app: System Usability Scale (SUS)
From baseline and during the study period
Perceived usefulness for patient-clinician communication
Time Frame: From baseline and during the trial period
Qualitative interviews
From baseline and during the trial period
Interviews with participants and clinicians/psychotherapists
Time Frame: From baseline and during the trial period
Qualitative interviews on an subsample
From baseline and during the trial period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

Hospital del Mar Research Institute (IMIM)
Research Centre of the German Foundation for Depression and Suicide Prevention
Monsenso
Monsenso A/S as sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101080651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sensitive data that cannot be anonymised completely.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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