- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05464550
Role of Self-focused Attention in Depression (RFASD)
May 23, 2023 updated by: Centre Hospitalier Henri Laborit
Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
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
-
-
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Poitiers, France, 86000
- Centre Hospitalier Henri Laborit
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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 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients with depressive disorders according to the Diagnostic and statistical Manual of Mental Disorders (DSM-V) criteria
- Men or women, aged 18 to 60
- patients without mental impairment
- patients without neurological impairment (epilepsy, encephalopathy, head trauma)
- patients with a sufficient command of French
- free patients, without guardianship or curators or subordination
- patients benefiting from coverage by a social security scheme or benefiting from it through a third party in accordance with the French law on biomedical research
- obtaining oral non-objection by the patient after clear and honest information about the study
- Patient with normal or corrected vision without rigid contact lenses
Exclusion Criteria:
- patients with an intelligence quotient < 70
- patients aged < 18 years or > 60 years
- patients with mental impairment
- patients with neurological impairment (epilepsy, encephalopathy, head trauma)
- patients who do not speak French well enough
- patients hospitalized under duress
- patients without social security
- Patient wearing rigid contact lenses
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
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eye tracking
Utilisation of a eye tracker on a screen.
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Eye movements on a screen are captured with an eye tracker during a repeated measures before/after a directed autobiographical recall.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of time
Time Frame: through study completion, an average of 10 months.
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Average percentage of time spent on the area of a reflective black computer screen after and before remembering a failure.
The area of interest encompasses the reflection of the patient's face, without his attention being explicitly drawn to this area.
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through study completion, an average of 10 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 8, 2021
Primary Completion (Actual)
June 15, 2022
Study Completion (Actual)
June 16, 2022
Study Registration Dates
First Submitted
April 21, 2022
First Submitted That Met QC Criteria
July 18, 2022
First Posted (Actual)
July 19, 2022
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 23, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A01098-33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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