Prevention of ANxiety and Depression Over Risk Assessment

NCT07185867 | Not Yet Recruiting

• 1 other identifier: PI21/01695
• Study Type: interventional
• Target: 2,595
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety; Prevention; m-Health

Keywords

Depression; Anxiety; Prevention; Randomized Controlled Trial; m-Health; App; Predictive risk algorithms

Outcome Measures

Primary Outcomes (1)

• 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).

  6 and 12 months follow-up

Secondary Outcomes (7)

• 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

Other Outcomes (4)

• Mediator: Physical activity (BPAQ-2)

  Baseline, 1, 6 and 12 months follow-up

• Mediator: Insomnia (AIS-5)

  Baseline, 1, 6 and 12 months follow-up

• Mediator: Social support (DUKE-UNC-11)

  Baseline, 1, 6 and 12 months follow-up

Study Arms (3)

Pandora-1 app intervention

EXPERIMENTAL

In this arm, participants will use an internet-based, self-guided and personalized intervention to prevent depression and anxiety, which also includes risk predictive algorithms, personalized prevention plans, decision support systems, monitoring and feedback.

Behavioral: Pandora-1 app with high levels of personalization, interaction, monitoring and feedback

Pandora-2 app intervention

EXPERIMENTAL

In this arm, participants will use an internet-based and self-guided intervention that includes psychoeducational brochures for the prevention of anxiety and depression that can be used when they want.

Other: Pandora-2 app with low levels of personalization, interaction, monitoring and feedback

Control Condition (usual care)

NO INTERVENTION

Participants in this arm, as is also the case with participants in the Pandora-1 and -2 arms, will continue to receive usual care from their health providers and will fill out the same questionnaires and reminders. However, they will not receive information about their responses or suggestions related to them, except those included in the security protocol on suicide risk and potential clinical diagnosis of anxiety disorders or depression.

Interventions

Pandora-1 app with high levels of personalization, interaction, monitoring and feedback BEHAVIORAL

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-1 app intervention

Pandora-2 app with low levels of personalization, interaction, monitoring and feedback OTHER

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.

Pandora-2 app intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent acceptance
• Having a valid telephone number
• Ownership of an Apple-Android-operating smartphone with an internet connection
• years old
• Habitually reside (\> 6 months/year) in Spain or Chile

You may not qualify if:

• 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
• Presence of clinically relevant anxiouys (GAD-7 score ≥ 10 points) or depressive symptoms (PHQ-9 score ≥ 10 points).

Sponsors & Collaborators

• The Mediterranean Institute for the Advance of Biotechnology and Health Research: lead
• 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

Study Sites (1)

Juan Ángel Bellón Saameño

Málaga, Málaga, Spain

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Alzheimer Disease

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Medicine

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): March 7, 2028
• Study Completion (Estimated): March 7, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

ES (1)