Prevention of ANxiety and Depression Over Risk Assessment: a Randomized Controlled Trial (the PANDORA-Predict-Plus-Prevent Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,595
- 试验地点
- 1
- 主要终点
- Combined onset of depression-anxiety event
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Combined onset of depression-anxiety event
时间窗: 6 and 12 months follow-up
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).
次要结局
- Depressive symptoms (PHQ-9)(Base line, 1, 6 and 12 months follow-up)
- Anxious symptoms (GAD-7)(Base line, 1, 6 and 12 months follow-up)
- Depression risk (predictD risk algorithm)(Baseline, 6 and 12 months follow-up)
- Anxiety risk (predictA risk algorithm)(Baseline, 6 and 12 months follow-up)
- Physical and mental quality of life (SF-12)(Base line, 1, 6 and 12 months follow-up)
- Acceptability and satisfaction with the Pandora app(1 and 6 months follow-up)
- Adverse effect (ad-hoc questionnaire)(1 and 6 months follow-up)
研究者
Juan Ángel Bellón
PhD, Medicine
Andalusian Health Service