Personalized Prevention of Depression in Primary Care

The Mediterranean Institute for the Advance of Biotechnology and Health Research

Status: Completed

Conditions: Depression

Treatments: Behavioral: e-predictD intervention; Other: Brief psychoeducational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03990792

PI15/00401

Details and patient eligibility

About

The main goal is to design, develop and evaluate a personalized intervention to prevent the onset of depression based on Information and Communications Technology (ICTs), risk predictive algorithms and decision support systems (DSS) for patients and general practitioners (GPs). The specific goals are 1) to design and develop a DSS, called e-predictD-DSS, to elaborate personalized plans to prevent depression; 2) to design and develop an ICT solution that integrates the DSS on the web, a mobile application (App), the risk predictive algorithm, different intervention modules and a monitoring-feedback system; 3) to evaluate the usability and adherence of primary care patients and their GPs with the e-predictD intervention; 4) to evaluate the effectiveness of the e-predictD intervention to reduce the incidence of major depression, depression and anxiety symptoms and the probability of major depression next year; 5) to evaluate the cost-effectiveness and cost-utility of the e-predictD intervention to prevent depression.

Methods: This is a randomized controlled trial with allocation by cluster (GPs), simple blind, two parallel arms (e-predictD vs "active m-Health control") and 1 year follow-up including 720 patients (360 in each arm) and 72 GPs (36 in each arm). Patients will be free of major depression at baseline and aged between 18 and 55 years old. Primary outcome will be the incidence of major depression at 12 months measured by CIDI. As secondary outcomes: depressive and anxiety symptomatology measured by PHQ-9 and GAD-7 and the risk probability of depression measured by predictD algorithm, as well as cost-effectiveness and cost-utility. The e-predictD intervention is multi-component and it is based on a DSS that helps the patients to elaborate their own personalized depression prevention plans, which the patient approves, and implements, and the system monitors offering feedback to the patient and to the GPs. It is an e-Health intervention because it is based on a web and m-Health because it is also implemented on the patient's smartphones through an App. In addition, it integrates a risk algorithm of depression, which is already validated (the predictD algorithm). It also includes an initial GP-patient interview and a specific training for the GP. Finally, a map of potentially useful local community resources to prevent depression will be integrated into the DSS.

Enrollment: 663 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PHQ-9 <10 at baseline
• Moderate-high risk of depression (predictD risk algorithm score ≥ 10%)

Exclusion criteria

• Not have a smartphone and internet for personal use
• Unable to speak Spanish
• Documented terminal illness
• Documented cognitive impairment
• Limiting sensory disorder (e.g. deafness)
• Documented serious mental illness (psychosis, bipolar, addictions, etc.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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663 participants in 2 patient groups

e-predictD intervention

Experimental group

Description:

In this arm, patients will receive a personalized intervention to prevent depression based on ICTs, risk predictive algorithms and decision support systems (DSS) for patients and General Practitioners (GPs).

Treatment:

Behavioral: e-predictD intervention

m-Health control

Active Comparator group

Description:

In this arm, patients will continue receiving the usual care from their GPs. In addition, they will use an App with the same appearance as the e-predictD App but it will only send weekly messages about physical and mental health management. This intervention is not personalized and does not include GP training and GP-patient interview.

Treatment:

Other: Brief psychoeducational intervention