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

September 25, 2019 updated by: Marta Miret, Universidad Autonoma de Madrid

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

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

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28029
        • Universidad Autónoma de Madrid. Department of Psychiatry. School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of Madrid, Spain.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Affect as measured by PANAS
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2018

Primary Completion (Actual)

September 2, 2018

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/00177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

3
Subscribe