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.
Informed consent acceptance
Having a valid telephone number
Ownership of an Apple-Android-operating smartphone with an internet connection
18-65 years old
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).
Parallel
Pandora-1 app with high levels of personalization, interaction, monitoring and feedback
BehavioralPandora-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.
Pandora-2 app with low levels of personalization, interaction, monitoring and feedback
Other interventionPandora-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.
Combined onset of depression-anxiety event
The primary outcome of this study will be a combined onset of depression-anxiety event (yes/no) as endpoint, which will include the following DSM-V diagnoses: major depressive disorder, generalized anxiety disorder, panic disorder, agoraphobia and social phobia as measured by standardized psychiatric interview (CIDI: Composite International Diagnostic Interview).
Depressive symptoms (PHQ-9)
Depressive symptoms will be measured by the PHQ-9, which is a reliable and valid 9-item measure of depression symptoms over the past 2 weeks. Each of the 9 items is scored as 0 (not at all), 1 (several days), 2 (more than half the days) or 3 (nearly every day). Summing the 9 items the score range is 0-27. This instrument is validated in Spanish and will be used from two different approaches: as screening at baseline (PHQ-9 scoring \<10: Negative test predictive value \>95%) and to quantify depression severity over time (at 1, 6 and 12 months follow-up).
Anxious symptoms (GAD-7)
Anxious symptoms will be measured by the GAD-7, which is also a reliable and valid 7-item measure of generalized anxiety symptoms, although it is also an effective screener for panic, social anxiety and posttraumatic stress disorders. Response options are similar to PHQ-9 (range from 0 = not at all, to 3 = nearly every day).Therefore, the total score ranges from 0-21. This instrument is validated in Spanish and will be used from two different approaches: as screening at baseline (GAD-7 scoring \<10: Negative test predictive value \>95%) and to quantify anxiety severity over time (at 1, 6 and 12 months follow-up).
Depression risk (predictD risk algorithm)
The predictD risk algorithm (C-index = 0.82) assesses a series of risk factors for depression disorders, including: educational level, physical abuse in childhood, depression throughout life, number of serious problems in close people, and dissatisfaction with living at home. The predictD risk algorithm for Chile (C-index = 0.75) is very similar to the Spanish one, excluding three risk factors (dissatisfaction with unpaid work, physical abuse in childhood and number of serious problems in close people) and including a new one (satisfaction with the relationship with their partner). Both risk algorithms will be used to quantify the risk of depression overtime and will be assessed at baseline, at 6 and 12 months follow-up.
Anxiety risk (predictA risk algorithm)
The predictA risk (C-index = 0.80) algorithm assesses the risk of anxiety in the next year. It includes a series of risk factors for anxiety disorders, including: sex, age, physical and mental quality of life, dissatisfaction with paid and unpaid work, financial difficulties, and medication for anxiety, depression or stress. This risk algorithm will be used to quantify the risk of anxiety overtime and will be assessed at baseline, at 6 and 12 months follow-up.
Mediator: Physical activity (BPAQ-2)
Physical activity will be measured using the Brief Physical Activity Questionnaire (BPAQ-2), a widely used tool assessing adult physical activity levels. It includes two questions on frequency and duration of moderate- and vigorous-intensity activities over the past week. Based on responses, individuals are classified as low (insufficiently active), moderate (at least 150 minutes of moderate-intensity activity or equivalent), or high (at least 300 minutes of moderate-intensity activity or equivalent). Additionally, a subsample of 404 RCT participants (202 insufficiently active assigned to Pandora-1 and 202 assigned to usual care) will be assessed for physical activity over 7-day periods (24 hours per day) using Actigraph GT3X accelerometers at baseline, 1 and 6 months. Those participants classified as insufficiently active by the BPAQ-2 who were reclassified as active by accelerometers at baseline, will be excluded from this subsample of 404 participants of the PANDORA study.
Mediator: Insomnia (AIS-5)
Athens Insomnia Scale (AIS-5) aims to measure sleep induction, awakenings during the night, final awakening, total sleep duration and general sleep quality. Participants are asked to score each item from 0 (no problem at all) to 3 (very serious problem), if they have experienced any difficulty sleeping at least three times a week during the previous month (in order to fulfil the ICD-10 diagnostic criteria). Insomnia (AIS-5) will be assessed at baseline, 1, 6 and 12 months. A subsample of 404 RCT participants (202 sedentary individuals randomly assigned to Pandora-1 and 202 assigned to usual care) will be assessed for quantity and quality of sleep over 7-day periods (24 hours per day) using Actigraph GT3X accelerometers at baseline, 1 and 6 months.
Mediator: Social support (DUKE-UNC-11)
Social support will be measured by using an affective social support item and another confidential social support item from the DUKE- UNC-11 questionnaire, which were selected for having the highest item-subscale correlation coefficients in the Spanish validation of this questionnaire. A higher score on the social support-related items suggests that an individual feels more connected and supported by their social network, which is associated with better mental health outcomes. Conversely, lower scores may indicate feelings of loneliness or lack of support, which could be linked to higher levels of distress or poorer quality of life. This measure will be assessed at baseline, and at 1, 6 and 12 months follow-up.
Mediator: Perseverative thinking (PTQ-9)
Perseverative Thinking Questionnaire (PTQ) measures repetitive negative thinking (RNT) and has been translated (also in Spanish) and validated in several countries. RNT has been found to be involved in the development and maintenance of several types of emotional problems (including depression and anxiety disorders) and has therefore been suggested to be a transdiagnostic process. RNT was defined as a style of thinking about one's problem (current, past, or future) or negative experiences (past or anticipated) with three key characteristics: (1) being repetitive, intrusive, and uncontrollable; (2) perceived as unproductive; and (3) capturing mental resources. PTQ had good reliability (internal consistence and test-retest reliability) and validity (factorial and construct validity) and it was sensitive to change for the prevention of anxiety and depression. We will use the PTQ short version (9 items). The response to each item is given using a 5-point Likert scale from 0 = never to
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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
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