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FEDD: Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population.

Sponsor
Universidad Autonoma de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT03360773
Collaborator
(none)
700
Enrollment
1
Location
15.6
Actual Duration (Months)
44.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to analyze both depressive symptomatology and psychological well-being fluctuation in a day-to-day basis in the general population, in order to identify contextual determinants of the mood and well-being changes

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Introduction: The Experience Sampling Method is a research tool to study what people do and feel in their day to day. It allows to analyse temporal relationships between variables and has a high ecological validity.

    Aim: To evaluate fluctuations of depressive symptoms and subjective well-being and to analyse the factors related to these fluctuations.

    Methodology: Longitudinal study that will follow up for two weeks a representative sample of the population aged 18 to 65 years living in Madrid using the Experience Sampling Method. An interviewer will visit the participants at their home to carry out a structured interview on mental health and well-being and to install a mobile app on the smart phone of participants in order for them to fill out information about their emotional state during the following two weeks. Participants will use the smart phone screen to fill out a brief questionnaire about their feelings, the activities they are doing and the people with whom they are interacting. Multilevel analysis based on lineal hierarchical models will be employed for data analysis as well as methods based on machine learning.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population (FEDD).
    Actual Study Start Date :
    Mar 10, 2018
    Actual Primary Completion Date :
    Sep 2, 2018
    Actual Study Completion Date :
    Jun 28, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Positive and Negative Affect as measured by PANAS [7 days]

      Current experience of positive and negative emotions, along with the extent to which they are felt, by means of an adapted version of PANAS questionnaire.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18-65 years old

    • Non-institutionalized resident in Madrid

    • To own a smart phone

    Exclusion Criteria:
    • To present noticeable cognitive or other limitations that impede following the interview

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad Autónoma de Madrid. Department of Psychiatry. School of Medicine Madrid Spain 28029

    Sponsors and Collaborators

    • Universidad Autonoma de Madrid

    Investigators

    • Principal Investigator: Marta Miret García, Ph.D, Universidad Autonoma de Madrid

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marta Miret, Ph.D., Assistant Professor, Universidad Autonoma de Madrid
    ClinicalTrials.gov Identifier:
    NCT03360773
    Other Study ID Numbers:
    • PI16/00177
    First Posted:
    Dec 4, 2017
    Last Update Posted:
    Sep 26, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Sep 26, 2019