NCT07185867

Prevention of ANxiety and Depression Over Risk Assessment

Prevention of ANxiety and Depression Over Risk Assessment: a Randomized Controlled Trial (the PANDORA-Predict-Plus-Prevent Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,595 (estimated)
• Sponsor: The Mediterranean Institute for the Advance of Biotechnology and Health Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The general goal is to design, develop and evaluate a personalized, self-guided and trans-diagnostic internet-based intervention to prevent anxiety and depression, based on predictive risk algorithms and decision support systems (DSS), in Spanish and Chilean adult population. Methods: We will conduct a three-arm parallel randomized controlled trial with one year of follow-up. A total of 2,595 depression- or/and anxiety-free participants (865 per group), aged 18-65, will be recruited and randomly assigned to one of two intervention groups or to the usual-care group (in a 1:1:1 ratio). Both interventions, Pandora-1 and Pandora-2, will be implemented via a smartphone application, the Pandora App. Pandora-1 is a self-guided and transdiagnostic intervention that includes 4 interactive intervention modules (move more, sleep better, improve relationships and emotional well-being), as well as predictive risk algorithms, decision support systems, and monitoring and feedback to implement personalized plans for the prevention of anxiety and depression. Pandora-2 is a psycho-educative intervention with predictive risk algorithms, minimally interactive and without personalization. The primary outcome is the combined rate of the onset of anxiety or depression (DSM-V diagnoses as measured by the CIDI interview) at 6 and 12 months. The secondary outcomes are the reduction of depressive (PHQ-9) and anxious (GAD-7) symptoms, risk of depression and anxiety (predictD and predictA risk algorithms), and the improvement of mental \& physical quality of life (SF-12), as well as acceptation and satisfaction with Pandora apps (u-MARS) and adverse effects (ad hoc questionnaire), which will be assessed at 1, 6 and 12 months. As mediators will be measured social support (Duke-UNC-2 items), physical activity (BPAQ-2), sleep (AIS-5), and repetitive negative thinking (PTQ-9) evaluated at 1, 6 and 12 months. We will use ActiGraph-GT3X accelerometers to assess physical activity and sleep at 1 and 6 months, in a subsample of 404 sedentary study participants.

Detailed description

The specific goals are: 1) to adapt the epD-Work App (an App developed to prevent depression in the workplace with predictive risk algorithms, decision support system, monitoring and feedback, repositories, communication systems and intervention modules) in a new App, the Pandora App, for the personalized anxiety and depression prevention in Spanish and Chilean adult population; 2) to evaluate the usability and adherence of the participants to the Pandora interventions; 3) to evaluate the acceptability and satisfaction of the participants regarding the Pandora interventions; 4) to evaluate the effectiveness of the Pandora interventions to reduce the onset of episodes of major depression and anxiety disorders; 5) to evaluate the effectiveness of the Pandora interventions in reducing depressive and anxious symptoms and the probability of developing depression and anxiety in the next 12 months (predict-D and predict-A risk algorithm); 6) to evaluate the effectiveness of the Pandora interventions to improve physical and mental quality of life; 7) to perform a causal analysis on the anxiety and depression preventive effect of the Pandora intervention taking into account several mediators and moderators; and 8) to evaluate the appearance of undesirable effects associated with the use of the Pandora interventions.

Conditions

• Depression
• Anxiety
• Prevention
• m-Health

Interventions

Type	Name	Description
BEHAVIORAL	Pandora-1 app with high levels of personalization, interaction, monitoring and feedback	Pandora-1 is a behavioral, self-guided and transdiagnostic intervention delivered via an app. It includes predictive risk algorithms, decision support systems (DSS), monitoring and feedback to implement personalized prevention plans (PPP) for anxiety and depression. The intervention has a biopsychosocial approach and offers 4 interactive modules: move more, sleep better, improve relationships and emotional well-being. Participants will receive personalized feedback at baseline, 1, 6 and 12 months, including their levels of depressive and anxiety symptoms over the past two weeks, their predicted risk of developing these disorders in the next year, and related modifiable risk factors (e.g. sedentary lifestyle, insomnia, low social support, poor mental quality of life). Based on this, the app offers suggestions (via DSS) and guides users to relevant content (PPP). Participants follow recommendations of choice, the app tracks these actions and provides feedback at baseline, 1 and 6 months.
OTHER	Pandora-2 app with low levels of personalization, interaction, monitoring and feedback	Pandora-2 is a psychoeducational self-guided and transdiagnostic intervention delivered via an app. This intervention also has a biopsychosocial orientation and includes a set of psychoeducational brochures for the prevention of anxiety and depression that can be used at any time. These read-only brochures will have contents on the same 4 intervention modules (move more, sleep better, improve relationships and emotional well-being). At baseline, 1 and 6, 12 months participants will also receive basic information about their level of depressive and anxiety symptoms over the past two weeks, their risk probability of depressive and anxiety episodes next year and some of their modifiable risk factors associated with such risk (e.g. sedentary lifestyle, insomnia, low social support and poor mental quality of life). However, in Pandora-2 intervention participants will have lower levels of interactive intervention components as suggestions from the DSS about PPP, monitoring and feedback.

Timeline

• Start date: 2026-02-15
• Primary completion: 2028-03-07
• Completion: 2028-03-07
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Spain