Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Personalized Prevention of Depression in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03990792
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Juan Ángel Bellón, Andalusian Health Service

Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 20, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
Incidence of major depression measured by the Composite International Diagnostic Interview (CIDI) [ Time Frame: 12 months ]
Composite International Diagnostic Interview (CIDI) is a structured diagnostic interview that provides current diagnoses of major depression
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Incidence of major depression (CIDI) [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT03990792 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 12 months ]
  • Cost-effectiveness and cost-utility [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Depressive symptoms (PHQ-9) [ Time Frame: 12 months ]
  • Anxious symptoms (GAD-7) [ Time Frame: 12 months ]
  • Probability of depression (predictD risk algorithm) [ Time Frame: 12 months ]
  • Cost-effectiveness and cost-utility [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Prevention of Depression in Primary Care
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • 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.)
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: e-predictD intervention
  • 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.
    Intervention: Other: Brief psychoeducational intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sonia Conejo-Cerón, PhD +34 951031417 soniafundacionimabis@hotmail.com
Contact: Patricia Moreno-Peral, PhD +34 951031347 predictmalaga@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990792
Other Study ID Numbers  ICMJE PI15/00401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan Ángel Bellón, Andalusian Health Service
Study Sponsor  ICMJE The Mediterranean Institute for the Advance of Biotechnology and Health Research
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account The Mediterranean Institute for the Advance of Biotechnology and Health Research
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP