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

NCT06919133 | Enrolling By Invitation DMC

• 1 other identifier: 101080651
• Study Type: interventional
• Target: 660
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Depression; Mental distress; Smartphone; Trial; self-management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Quality of Life

  From enrollmetn to end of treatment af 12 months

• Generalized Anxiety Disorder 7 items 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)

  From baseline and during the 12 months study period

• User-reported healthcare contacts

  From baseline and during the 12 months study period

Other Outcomes (3)

• Usability of the app: System Usability Scale (SUS)

  From baseline and during the study period

• Perceived usefulness for patient-clinician communication

  From baseline and during the trial period

• Interviews with participants and clinicians/psychotherapists

  From baseline and during the trial period

Study Arms (2)

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

Device: The MENTINA app

Control

PLACEBO COMPARATOR

The app is installed for outcome measures, but no access to the content of the app is provided.

Other: Control

Interventions

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.

Smartphone-based self-monitoring and rule-based feedback

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Hospital del Mar Research Institute (IMIM): collaborator
• Monsenso: collaborator
• Research Centre of the German Foundation for Depression and Suicide Prevention: collaborator
• Monsenso A/S as sponsor: collaborator

Study Sites (3)

Psychiatric Center Copenhagen

Frederiksberg, 2000, Denmark

Location

Frankfurt University Hospital

Frankfurt, Germany

Location

Hospital del Mar

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 41638726 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Dr.Med.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); DK (1); ES (1)