The general goal is to design, develop and evaluate a personalized, self-guided andtrans-diagnostic internet-based intervention to prevent anxiety and depression, based onpredictive risk algorithms and decision support systems (DSS), in Spanish and Chileanadult population.Methods: We will conduct a three-arm parallel randomized controlled trial with one yearof follow-up. A total of 2,595 depression- or/and anxiety-free participants (865 pergroup), aged 18-65, will be recruited and randomly assigned to one of two interventiongroups or to the usual-care group (in a 1:1:1 ratio). Both interventions, Pandora-1 andPandora-2, will be implemented via a smartphone application, the Pandora App. Pandora-1is a self-guided and transdiagnostic intervention that includes 4 interactiveintervention modules (move more, sleep better, improve relationships and emotionalwell-being), as well as predictive risk algorithms, decision support systems, andmonitoring and feedback to implement personalized plans for the prevention of anxiety anddepression. Pandora-2 is a psycho-educative intervention with predictive risk algorithms,minimally interactive and without personalization. The primary outcome is the combinedrate of the onset of anxiety or depression (DSM-V diagnoses as measured by the CIDIinterview) 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 andpredictA 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 adverseeffects (ad hoc questionnaire), which will be assessed at 1, 6 and 12 months. Asmediators 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 and6 months, in a subsample of 404 sedentary study participants.
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.
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.
Inclusion Criteria:
- Informed consent acceptance
- Having a valid telephone number
- Ownership of an Apple-Android-operating smartphone with an internet connection
- 18-65 years old
- Habitually reside (> 6 months/year) in Spain or Chile
Exclusion Criteria:
- 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).
Juan Ángel Bellón Saameño
Málaga 2514256, Málaga, Spain
Not Provided