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

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.

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 symptoms will be available.

Rules for feedback based of self-reported measures will be developed. Based on the self-reported measures participants will be suggested to read items from the library or call emergency health care facilities.

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)