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

Summary

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.

Conditions

• Depression - Major Depressive Disorder
• Mental Distress

Interventions

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.

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.

Sponsors & Collaborators

• Hospital del Mar Research Institute (IMIM)

  collaborator OTHER

• Research Centre of the German Foundation for Depression and Suicide Prevention

  collaborator UNKNOWN

• Monsenso

  collaborator INDUSTRY

• Monsenso A/S as sponsor

  collaborator UNKNOWN

• Mental Health Services in the Capital Region, Denmark

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-13

Primary Completion

2027-05-01

Completion

2027-05-01

Countries

• Denmark
• Germany
• Spain

Study Locations