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

Официальное название

The Effect of Digital Markers in the Self-management of Depressive Symptoms - The MENTINA Randomized Controlled Parallel Group Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое Control
  The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.

Первичные конечные точки

• Patient Health Questionnaire 9 items (PHQ-9) [Срок оценки: From enrollment and during the study period of 12 months]

Вторичные конечные точки (7)

• Quality of Life [Срок оценки: From enrollmetn to end of treatment af 12 months]
• Generalized Anxiety Disorder 7 items scale (GAD-7) [Срок оценки: From enrollment to end of treatment at 12 months]
• PHQ-9 [Срок оценки: From baseline and during the 12 months study period]
• Perceived Stress Scale (PSS) [Срок оценки: From baseline and during the 12 months study period]
• User-reported healthcare contacts [Срок оценки: From baseline and during the 12 months study period]
• Negative effects: Negative Effects Questionnaire (NEQ) [Срок оценки: Form baseline and during the 12 months study period]
• PHQ-9 [Срок оценки: From baseline and during the 12 months study period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Psychiatric Center Copenhagen — Frederiksberg

Германия · 1 центр

• Frankfurt University Hospital — Frankfurt

Испания · 1 центр

• Hospital del Mar — Barcelona

Публикации

• 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: PMID 41638726

Идентификаторы

NCT: NCT06919133 · 101080651

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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