The PredictPlusPrevent Study
- Conditions
- DepressionAnxiety Disorders
- Interventions
- Behavioral: Predictplusprevent interventionOther: Psychoeducational intervention
- Registration Number
- NCT06351800
- Lead Sponsor
- The Mediterranean Institute for the Advance of Biotechnology and Health Research
- Brief Summary
Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).
Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 9000
- Age between 18 and 55 years.
- Participants must have a smartphone for their own use in the next year.
- Not signing the informed consent.
- Having depression and/or anxiety at baseline according to the PRIME-MD questionnaire.
- Living outside of Spain.
- Having a severe mental disorder (psychosis, bipolar disorder, addictions, etc.), a terminal illness or cognitive impairment (dementia).
- Difficulties in understanding Spanish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Predictplusprevent intervention Predictplusprevent intervention The intervention will provide information about the likelihood of experiencing depression and anxiety. Additionally, it will offer a personalized depression prevention plan (PPP) based on various interventions such as physical exercise, sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts. Active control group Psychoeducational intervention The intervention in the active control group will involve assessing the risk level of experiencing depression and/or anxiety in the next 12 months every 3 months. Additionally, participants assigned to this intervention will have free access to the 24 self-help booklets for preventing depression and anxiety included in the 'predictplusprevent' web platform. However, this group will not receive personalized prevention plans, decision support systems, or monitoring and feedback. They will also not have access to the 8 self-guided and interactive modules used in the intervention group.
- Primary Outcome Measures
Name Time Method Incidence of depression and/or anxiety disorders. 12 months Incidence of depression and/or anxiety disorders by Primary Care Evaluation of Mental Disorders (PRIME-MD). PRIME-MD is a diagnostic tool to diagnose depression and anxiety disorders.
- Secondary Outcome Measures
Name Time Method Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). 12 months The Patient Health Questionnaire-9 (PHQ-9) measures symptoms of depression through 9 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of depression, the scalen range is 0 to 27 (9 items).
Probability of anxiety measured by the Spanish predictA risk algorithm. 12 months The Spanish predictA risk algorithm measures 12 risk factors for anxiety disorders.
Quality of life measured by the 12-item Short Form (SF-12). 12 months The 12-item Short Form (SF-12) measures quality of life related to physical health and quality of life related to mental health. Scores on the scales range from 0 to 100. Higher scores are equivalent to better health-related quality of life.
Probability of depression measured by the Spanish predictD risk algorithm. 12 months The Spanish predictD risk algorithm measures 13 risk factors for depression.
Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7). 12 months The General Anxiety Questionnaire (GAD-7) measures generalized anxiety disorder through 7 items, each of which is scored 0 ('not at all') to 3 ('nearly every day'). Low scores are equivalent to less symptoms of anxiety, the scale range is 0 to 21 (7 items).