Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students (PROMES-U Study) (PROMES-U)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Depressive Symptoms
• Intervention / Treatment: Behavioral: MyMoodCoach

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordi Alonso; Phone Number: 93 316 07 60; Email: jalonso@imim.es
• Study Contact Backup: Name: PROMES-U Study; Email: promes@imim.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyMoodCoach Intervention	Behavioral: MyMoodCoach; 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.
No Intervention: Treatment-as-usual monitoring control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 6 weeks and at 6 months and 12 months post randomization

Collaborators and Investigators

• Sponsor: University of the Balearic Islands
• Collaborators: Universitat Jaume I; University of Malaga; Universidad de Zaragoza; Instituto de Salud Carlos III; Universidad Miguel Hernandez de Elche; Universitat Pompeu Fabra; Hospital del Mar Research Institute (IMIM)
• Investigators: Principal Investigator: Jordi Alonso, Hospital de Mar Medical Research Institute (IMIM)

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Depression; Anxiety Disorders
• Other Study ID Numbers: PI20/00006; 2020/9198/I (Other Identifier: INSTITUTO DE SALUD CARLOS III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No