Personalized Prevention of Depression in Primary Care

Sponsor

The Mediterranean Institute for the Advance of Biotechnology and Health Research (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03990792

Collaborator

Preventive Services and Health Promotion Research Network (Other), Institute of Biomedical Research in Málaga (IBIMA) (Other), Andalusian Regional Ministry of Health (Other), European Regional Development Fund (FEDER) (Other), University of Malaga (Other)

663

Enrollment

Locations

Arms

27.9

Anticipated Duration (Months)

110.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: e-predictD intervention Other: Brief psychoeducational intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

663 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: e-predictD intervention 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).	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.
Active Comparator: m-Health control 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.	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.)

Arm

Intervention/Treatment

Experimental: e-predictD intervention

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).

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.

Active Comparator: m-Health control

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.

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.)

Outcome Measures

Primary Outcome Measures

Incidence of major depression measured by the Composite International Diagnostic Interview (CIDI) [12 months]
Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression

Secondary Outcome Measures

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 scale range is 0 to 27 (9 items)
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)
Probability of depression (predictD risk algorithm) [12 months]
Cost-effectiveness and cost-utility [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.)

Contacts and Locations

Locations

	Site	City	Country
1	Juan M. Mendive	Barcelona	Spain
2	María Isabel Ballesta Rodríguez	Jaén	Spain
3	Antonina Rodríguez Bayón	Linares	Spain
4	Juan Á Bellón	Málaga	Spain
5	Emiliano Rodríguez	Salamanca	Spain
6	Yolanda López del Hoyo	Zaragoza	Spain

Sponsors and Collaborators

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