Personalized Prevention of Depression in Primary Care

Depression Clinical Trial

Official title:

Preventing the Onset of Depression Through a Personalized Intervention Based on ICTs, Risk Prediction Algorithms and Decision Support Systems for Patients and GPs: the e-predictD Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03990792
• Other study ID #: PI15/00401
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: The Mediterranean Institute for the Advance of Biotechnology and Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 663
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• e-predictD intervention
The intervention is based on validated risk algorithms to predict depression and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps patients to develop their own personalized plans to prevent (PPP) depression; 3) eight intervention modules (the core of the system) including activities to prevent depression, to be proposed by the DSS and chosen by the patient. The intervention is biopsychosocial and multi-component, including the following modules: physical exercise, improving sleep, expanding relationships, problem solving, improving communication skills, assertiveness training, making decisions and managing thoughts. Patients will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 3, 6 and 9 months. The intervention also includes an initial and single 15-minute face-to-face GP-patient interview.

Other:
• Brief psychoeducational intervention
The intervention consists of an App that weekly send brief psychoeducational messages about physical and mental health (depression, anxiety, sleep hygiene, physical activity, etc.)

Locations

Country	Name	City	State
Spain	Juan M. Mendive	Barcelona
Spain	María Isabel Ballesta Rodríguez	Jaén
Spain	Antonina Rodríguez Bayón	Linares
Spain	Juan Á Bellón	Málaga
Spain	Emiliano Rodríguez	Salamanca
Spain	Yolanda López del Hoyo	Zaragoza

Sponsors (6)

Lead Sponsor	Collaborator
The Mediterranean Institute for the Advance of Biotechnology and Health Research	Andalusian Regional Ministry of Health, European Regional Development Fund (FEDER), Institute of Biomedical Research in Málaga (IBIMA), Preventive Services and Health Promotion Research Network, University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major depression measured by the Composite International Diagnostic Interview (CIDI)	Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression	12 months
Secondary	Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)	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 scale range is 0 to 27 (9 items)	12 months
Secondary	Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)	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)	12 months
Secondary	Probability of depression (predictD risk algorithm)		12 months
Secondary	Cost-effectiveness and cost-utility		12 months