- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03360773
Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population. (FEDD)
Emotional Fluctuations in the Flow of Daily Life. Ecological Analysis of Depressive Symptoms in the General Population (FEDD).
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain, 28029
- Universidad Autónoma de Madrid. Department of Psychiatry. School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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.
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7 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Miret García, Ph.D, Universidad Autonoma de Madrid
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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