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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03360773
Other study ID # PI16/00177
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2018
Est. completion date June 28, 2019

Study information

Verified date September 2019
Source Universidad Autonoma de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date June 28, 2019
Est. primary completion date September 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Universidad Autónoma de Madrid. Department of Psychiatry. School of Medicine Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Positive and Negative Affect as measured by PANAS 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
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