Status:

ENROLLING_BY_INVITATION

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

Lead Sponsor:

Mental Health Services in the Capital Region, Denmark

Collaborating Sponsors:

Hospital del Mar Research Institute (IMIM)

Research Centre of the German Foundation for Depression and Suicide Prevention

Conditions:

Depression - Major Depressive Disorder

Mental Distress

Eligibility:

All Genders

18+ years

Phase:

NA

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 o...

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 s...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

May 13 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2027

Estimated Enrollment :

660 Patients enrolled

Trial Details

Trial ID

NCT06919133

Start Date

May 13 2025

End Date

May 1 2027

Last Update

May 16 2025

Active Locations (1)

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1

Psychiatric Center Copenhagen

Frederiksberg, Denmark, 2000