Depression - Major Depressive Disorder, Mental Distress
Conditions
Keywords
Depression, Mental distress, Smartphone, Trial, self-management
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.
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 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.
Interventions
DEVICEThe 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.
OTHERControl
The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.
Sponsors
Hospital del Mar Research Institute (IMIM)
Research Centre of the German Foundation for Depression and Suicide Prevention
Monsenso
Monsenso A/S as sponsor
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 9 items (PHQ-9) | From enrollment and during the study period of 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 | From baseline and during the 12 months study period | * Monthly change in PHQ-9 scores * Response rate defined as the proportion of participants with ≥50% reduction in PHQ-9 * Remission rate defined as PHQ-9 ≤9 and ≥5-point improvement * PHQ-9 scores at 6 months * Area Under the Curve (AUC) for PHQ-9 over the trial period * Subgroup analysis: differences between the two groups in PHQ-9 analyzed separately for: * People with mental distress (without lifetime depression) * People with a lifetime diagnosis of depression |
| Perceived Stress Scale (PSS) | From baseline and during the 12 months study period | Differences between the group |
| User-reported healthcare contacts | From baseline and during the 12 months study period | Number of healthcare contact during the study |
| Negative effects: Negative Effects Questionnaire (NEQ) | Form baseline and during the 12 months study period | Differences between the two groups |
| Quality of Life | From enrollmetn to end of treatment af 12 months | Differences between the intervention group and the control group in the level of quality of life according to the WHO Quality of life BREF16 (WHO QoL) |
| Generalized Anxiety Disorder 7 items scale (GAD-7) | From enrollment to end of treatment at 12 months | Differences between the intervention group and the control group in the level of anxiety symptoms according to the Generalized Anxiety Disorder scale (GAD-7) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interviews with participants and clinicians/psychotherapists | From baseline and during the trial period | Qualitative interviews on an subsample |
| Usability of the app: System Usability Scale (SUS) | From baseline and during the study period | Usability of the app: System Usability Scale (SUS) |
| Perceived usefulness for patient-clinician communication | From baseline and during the trial period | Qualitative interviews |
Countries
Denmark, Germany, Spain
Outcome results
None listed