Depressive SymptomsPROMES-UNCT06078007
Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students (PROMES-U Study)
A study testing MyMoodCoach in people with Depressive Symptoms and Anxiety, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
Background: Symptoms of depression and anxiety are prevalent among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Anxiety
- What is being tested?
- MyMoodCoach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants are all undergraduate students at the 6 participating universities and students followed in the PROMES-U observational study
- Having 18 years of age or more
- Having literacy in Spanish
- Having access to a smartphone (Android or Apple)
- With mild or moderate depression and/or anxiety symptoms screened (i.e., depression (5≤ (PHQ-9) ≤14); and/or anxiety (5≤ GAD-7 ≤14).
Who cannot join
- Moderately severe or severe depression and/or anxiety (i.e., PHQ-9≥15 and/or GAD-7≥15)
- High suicide risk
- A history of severe psychiatric disorder (e.g., bipolar, psychosis)
- Being on mental health treatment (i.e., medication, psychotherapy or other intervention)
- Students with high suicide risk will receive a clinical alert recommending them to visit a specialist and a list of available mental health resources.
Trial locations and contacts
1 site in 1 country.
PROMES-U Study contact
Spain1 site, 1 recruiting
- Recruiting
Miquel Roca
Palma de Mallorca, Balearic Islands, 07122
Miquel Roca, phD, 971173267, mroca@uib.es
About this study
Official title: Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students: a Multicenter Randomized Controlled Trial (PROMES-U Study)
Background: Symptoms of depression and anxiety are prevalent among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. There is a need to evaluate the effectiveness of guided preventive mental health interventions for depression and anxiety in university students.
Methods: two-arm multicenter randomized controlled trial (RCT), addressed to undergraduate students from 6 public universities with symptoms of depression and/or anxiety. Students will be evaluated through an online survey assessing mental health problems, use of mental health services, sociodemographic variables, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, personality and university experiences. A total of 600 students will be randomly assigned to: intervention group (guided E-health prevention intervention) or control group (treatment as usual with self-monitoring). The intervention, in app format, is based on principles of cognitive behavioral therapy, includes weekly feedback based on content and participation from a psychologist and self-monitoring. Assessments will take place post-intervention (up to 6 weeks), at 6 months and 12 months after randomization. The primary outcome will be the reduction of depressive or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes of the RCT will be mental wellbeing, academic stress, comorbid symptoms, and adherence. Analyses will be conducted on an intention-to-treat and per protocol basis.
Discussion: The results of the PROMES-U RCT will provide valuable information on a guided preventive online intervention that could be delivered in the campus context. In addition, results will provide information on the positive impact of the intervention on other relevant factors involved in mental health among university students.
- Conditions
- Depressive Symptoms, Anxiety
- Being tested
- MyMoodCoach
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMoodCoachBehavioural
The MyMoodCoach prevention intervention is an evidence-based online intervention based on cognitive-behavioral therapy principles such as behavioral activation, problem solving and challenging negative thoughts.
| Study group | Role | What they receive |
|---|---|---|
| MyMoodCoach Intervention | Experimental | Not described Receives: Behavioral: MyMoodCoach |
| Treatment-as-usual monitoring control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of depressive symptoms
The primary outcome will be the change of depressive symptoms at post-intervention (up to 6 weeks), 6 months and 12 months post randomization, considering the minimal clinically relevant change in the scores of Patient Health Questionnaire-9 (PHQ-9) and the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS).
The PHQ-9 range from 0 to 27, higher scores mean a worse outcome. The PHQ-ADS range from 0 to 48 with higher scores indicating more severe depression.
Measured: Up to 6 weeks, at 6 months and 12 months after randomization
Change of anxiety symptoms
The primary outcome will be the change of anxiety symptoms at post-intervention (up to 6 weeks), 6 months and 12 months post randomization, considering the minimal clinically relevant change in the scores of Generalized Anxiety Disorder -7 (GAD-7) he Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS).
The GAD-7 range from 0 to 21, higher scores mean a worse outcome. The PHQ-ADS range from 0 to 48 with higher scores indicating more severe anxiety.
Measured: Up to 6 weeks and at 6 months and 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start25 Oct 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Universitat Jaume I, Universidad Miguel Hernandez de Elche, Universitat Pompeu Fabra, Universidad de Zaragoza, University of Malaga, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Jordi Alonso, Principal investigator, Hospital de Mar Medical Research Institute (IMIM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078007
- Sponsor's protocol ID
- PI20/00006
- Other IDs
- 2020/9198/I
- Acronym
- PROMES-U
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2023
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballester L, Gili M, Roca M, Forteza-Rey I, Soto-Sanz V, Vilagut G, Amigo F, Moreno-Kustner B, Mortier P, Piqueras JA, Portillo-Van Diest A, Rebagliato M, Rodriguez-Jimenez T, Alonso J; PROMES-U study group. Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial. BMC Public Health. 2025 Nov 3;25(1):3740. doi: 10.1186/s12889-025-24752-3.
PubMed 41184908
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students: a Multicenter Randomized Controlled Trial (PROMES-U Study)
- ClinicalTrials.gov ID
- NCT06078007
- Acronym / sponsor ID
- PROMES-U / PI20/00006
- Conditions
- Depressive Symptoms, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Universitat Jaume I, Universidad Miguel Hernandez de Elche, Universitat Pompeu Fabra, Universidad de Zaragoza, University of Malaga, Instituto de Salud Carlos III
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Symptoms of depression and anxiety are prevalent among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. There is a need to evaluate the effectiveness of guided preventive mental health interventions for depression and anxiety in university students.
Methods: two-arm multicenter randomized controlled trial (RCT), addressed to undergraduate students from 6 public universities with symptoms of depression and/or anxiety. Students will be evaluated through an online survey assessing mental health problems, use of mental health services, sociodemographic variables, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, personality and university experiences. A total of 600 students will be randomly assigned to: intervention group (guided E-health prevention intervention) or control group (treatment as usual with self-monitoring). The intervention, in app format, is based on principles of cognitive behavioral therapy, includes weekly feedback based on content and participation from a psychologist and self-monitoring. Assessments will take place post-intervention (up to 6 weeks), at 6 months and 12 months after randomization. The primary outcome will be the reduction of depressive or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes of the RCT will be mental wellbeing, academic stress, comorbid symptoms, and adherence. Analyses will be conducted on an intention-to-treat and per protocol basis.
Discussion: The results of the PROMES-U RCT will provide valuable information on a guided preventive online intervention that could be delivered in the campus context. In addition, results will provide information on the positive impact of the intervention on other relevant factors involved in mental health among university students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyMoodCoach Intervention | Experimental | Behavioral: MyMoodCoach |
| Treatment-as-usual monitoring control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible participants are all undergraduate students at the 6 participating universities and students followed in the PROMES-U observational study
- Having 18 years of age or more
- Having literacy in Spanish
- Having access to a smartphone (Android or Apple)
- With mild or moderate depression and/or anxiety symptoms screened (i.e., depression (5≤ (PHQ-9) ≤14); and/or anxiety (5≤ GAD-7 ≤14).
Key exclusion criteria (5 listed)
- Moderately severe or severe depression and/or anxiety (i.e., PHQ-9≥15 and/or GAD-7≥15)
- High suicide risk
- A history of severe psychiatric disorder (e.g., bipolar, psychosis)
- Being on mental health treatment (i.e., medication, psychotherapy or other intervention)
- Students with high suicide risk will receive a clinical alert recommending them to visit a specialist and a list of available mental health resources.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyMoodCoachThe MyMoodCoach prevention intervention is an evidence-based online intervention based on cognitive-behavioral therapy principles such as behavioral activation, problem solving and challenging negative thoughts. | Behavioural | MyMoodCoach Intervention |
Primary outcome
Change of depressive symptoms
Time frame: Up to 6 weeks, at 6 months and 12 months after randomization
The primary outcome will be the change of depressive symptoms at post-intervention (up to 6 weeks), 6 months and 12 months post randomization, considering the minimal clinically relevant change in the scores of Patient Health Questionnaire-9 (PHQ-9) and the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The PHQ-9 range from 0 to 27, higher scores mean a worse outcome. The PHQ-ADS range from 0 to 48 with higher scores indicating more severe depression.
Change of anxiety symptoms
Time frame: Up to 6 weeks and at 6 months and 12 months post randomization
The primary outcome will be the change of anxiety symptoms at post-intervention (up to 6 weeks), 6 months and 12 months post randomization, considering the minimal clinically relevant change in the scores of Generalized Anxiety Disorder -7 (GAD-7) he Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS). The GAD-7 range from 0 to 21, higher scores mean a worse outcome. The PHQ-ADS range from 0 to 48 with higher scores indicating more severe anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 41184908Ballester L, Gili M, Roca M, Forteza-Rey I, Soto-Sanz V, Vilagut G, Amigo F, Moreno-Kustner B, Mortier P, Piqueras JA, Portillo-Van Diest A, Rebagliato M, Rodriguez-Jimenez T, Alonso J; PROMES-U study group. Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial. BMC Public Health. 2025 Nov 3;25(1):3740. doi: 10.1186/s12889-025-24752-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PROMES-U Study contact
Jordi Alonso principal investigator
Hospital de Mar Medical Research Institute (IMIM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyMoodCoach in people with Depressive Symptoms and Anxiety, run by University of the Balearic Islands at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordi Alonso (93 316 07 60, jalonso@researchmar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of depressive symptoms (time frame: Up to 6 weeks, at 6 months and 12 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06078007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.