NCT07185867

Prevention of ANxiety and Depression Over Risk Assessment

Not yet recruiting NA Last updated 22 September 2025

What this trial tests

NA trial testing Pandora-1 app with high levels of personalization, interaction, monitoring and feedback in Depression in 2,595 participants. Not yet recruiting.

Timeline

15 February 2026

Primary endpoint
7 March 2028

7 March 2028

Quick facts

Lead sponsor	The Mediterranean Institute for the Advance of Biotechnology and Health Research
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	2,595
Start date	15 February 2026
Primary completion	7 March 2028
Estimated completion	7 March 2028
Sites	1 location across Spain

Drugs / interventions tested

• Pandora-1 app with high levels of personalization, interaction, monitoring and feedback
• Pandora-2 app with low levels of personalization, interaction, monitoring and feedback

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →
• Prevention — all drugs for Prevention →
• m-Health — all drugs for m-Health →

Sponsor

The Mediterranean Institute for the Advance of Biotechnology and Health Research

Who can join

Adults 18 to 65, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.