NCT06919133: MENTINA

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

ENROLLING BY INVITATION NA Last updated 14 January 2026

What this trial tests

NA trial testing The MENTINA app in Depression - Major Depressive Disorder in 660 participants. Enrolling by invitation.

Timeline

13 May 2025

Primary endpoint
1 May 2027

1 May 2027

Quick facts

Lead sponsor	Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	660
Start date	13 May 2025
Primary completion	1 May 2027
Estimated completion	1 May 2027
Sites	3 locations across Denmark, Germany, Spain

Drugs / interventions tested

• The MENTINA app
• Control

Conditions studied

• Depression - Major Depressive Disorder — all drugs for Depression - Major Depressive Disorder →
• Mental Distress — all drugs for Mental Distress →

Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Who can join

18 and older, any sex, with Depression - Major Depressive Disorder or Mental Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial.
   Faurholt-Jepsen M, Dyreholt MS, Kyster NB, Iversen N, et al · · 2026 · PMID 41638726 · DOI 10.1136/bmjopen-2025-115773
2. Harnessing digital health interventions to address the heterogeneity of depression: a systematic review.
   Alsalloum G, Dalibalta S, Hadijat Y. · · 2025 · PMID 41341467 · DOI 10.3389/fdgth.2025.1654745