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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,595
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.
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.
Juan Ángel Bellón Saameño
Málaga, Málaga, Spain
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).
Time frame: 6 and 12 months follow-up
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).
Time frame: Base line, 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).
Time frame: Base line, 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.
Time frame: Baseline, 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.
Time frame: Baseline, 6 and 12 months follow-up
Physical and mental quality of life (SF-12)
The SF-12 is included in both predictA and predictD risk algorithms and it is a valid a reliable instrument which gives measures of the physical and mental quality of life with a range of 0-100 points (higher score means better quality of life). The SF-12 will be assessed at baseline, and at 1, 6 and 12 months follow-up.
Time frame: Base line, 1, 6 and 12 months follow-up
Acceptability and satisfaction with the Pandora app
Information on the use, adherence and acceptability of the Pandora intervention will be obtained automatically through the app. Some of these indicators are as follows: activity completion rates, completed assessments, amount of time spent in-app, frequency of use and number of log-ins. The U-MARS (User Version of the Mobile App Rating Scale) evaluates the quality and satisfaction of mobile health applications (Apps). The U-MARS consists of 27 items grouped into different domains: engagement, functionality, aesthetics, information quality and subjective quality. It uses a scale from 1 = "poor" to 5 = "excellent". Higher scores indicate better quality and satisfaction of the app. This measure will be assessed at 1 and 6 months follow-up.
Time frame: 1 and 6 months follow-up
Adverse effect (ad-hoc questionnaire)
An ad-hoc questionnaire will be designed to evaluate adverse effects arising from the Pandora app in order to gather information about any negative experiences or unintended consequences users may encounter while using the app. The primary purpose of this ad-hoc questionnaire is to capture user feedback on potential negative outcomes associated with the intervention (in general or due to a specific part of the intervention). Also, items of the questionnaire will assess how much that negative experience affects the wellbeing of the participants. This information will help in the future to make necessary adjustments to improve user experience, enhance safety features, and ensure that the app effectively supports users' health without causing harm. This measured will be assessed only at 1 and 6 months follow-up.
Time frame: 1 and 6 months follow-up
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