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Search / Trial NCT06919133

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

Launched by MENTAL HEALTH SERVICES IN THE CAPITAL REGION, DENMARK · Apr 2, 2025

Trial Information

Current as of July 27, 2025

Enrolling by invitation

Keywords

Depression Mental Distress Smartphone Trial Self Management

ClinConnect Summary

The MENTINA trial is studying whether a smartphone app can help people manage their depression symptoms better. This app allows users to track their feelings and receive feedback based on their responses. The trial will involve 660 adults from Denmark, Germany, and Spain who have experienced depressive symptoms or episodes. To participate, individuals must be 18 or older, have a PHQ-9 score greater than 8 (indicating significant depressive symptoms), and own a smartphone. However, people with certain serious mental health conditions, like dementia or schizophrenia, or those at risk of suicide will not be eligible.

Participants in the trial will use the app over a 12-month period, where they will report their symptoms every two weeks. While we do not expect serious side effects, some individuals might find that focusing on their symptoms could temporarily worsen their feelings. The goal of this trial is to see if the MENTINA app can be a helpful tool for individuals struggling with depression, making it easier for them to manage their mental health.

Gender

ALL

Eligibility criteria

  • 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)

About Mental Health Services In The Capital Region, Denmark

The Mental Health Services in the Capital Region of Denmark is a leading clinical trial sponsor dedicated to advancing psychiatric research and improving mental health care delivery. Operating within a robust healthcare framework, the organization focuses on innovative treatment methodologies and evidence-based practices, collaborating with multidisciplinary teams to conduct rigorous clinical trials. By prioritizing patient-centered outcomes and leveraging cutting-edge technology, the Mental Health Services aim to enhance therapeutic interventions and contribute to the global understanding of mental health disorders. Their commitment to research excellence fosters a culture of continuous improvement and collaboration, ultimately striving to elevate the standards of mental health services in the region and beyond.

Locations

Frederiksberg, , Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported