Prevention of ANxiety and Depression Over Risk Assessment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Mediterranean Institute for the Advance of Biotechnology and Health Research

About this trial

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.

Eligibility criteria

Qualifiers

Informed consent acceptance

Having a valid telephone number

Ownership of an Apple-Android-operating smartphone with an internet connection

18-65 years old

Disqualifiers

Difficulty reading and/or understanding Spanish

Suffer from disabling neurological conditions (dementia, blindness, etc.) that makes it difficult to use smartphone, terminal illness with a life expectancy < 12 months, a history of severe mental disorders confirmed by a healthcare professional (schizophrenia or psychosis, bipolar, anoxeria, bulimia or personality disorders), having alcohol or substance use disorder within the past year

Currently receiving face to face or via internet psychological treatment (currently taking antidepressants or anxiolytics is not an exclusion criterion, but their use will be taken into account throughout the follow-up)

Presence of clinically relevant anxiouys (GAD-7 score ≥ 10 points) or depressive symptoms (PHQ-9 score ≥ 10 points).

Trial design

Treatments tested in this trial

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

Treatment groups

2,595 Participants
are divided into 3 treatment groups

Sponsors and collaborators

The Mediterranean Institute for the Advance of Biotechnology and Health Research

Lead sponsor

Andalusian Health Service

Sponsor institution

European Regional Development Fund

Collaborator

Research Network on Chronicity, Primary Care, and Health Promotion

Collaborator

Carlos III Health Institute

Collaborator

IBIMA Plataforma BIONAD

Collaborator

Andalusian Regional Ministry of Health

Collaborator