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Role of Self-focused Attention in Depression (RFASD)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eye tracker
Sponsored by
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Henri Laborit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eye tracking

Arm Description

Utilisation of a eye tracker on a screen.

Outcomes

Primary Outcome Measures

Percentage of time
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.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
May 23, 2023
Sponsor
Centre Hospitalier Henri Laborit
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1. Study Identification

Unique Protocol Identification Number
NCT05464550
Brief Title
Role of Self-focused Attention in Depression
Acronym
RFASD
Official Title
Role of Self-focused Attention in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eye tracking
Arm Type
Experimental
Arm Description
Utilisation of a eye tracker on a screen.
Intervention Type
Behavioral
Intervention Name(s)
Eye tracker
Intervention Description
Eye movements on a screen are captured with an eye tracker during a repeated measures before/after a directed autobiographical recall.
Primary Outcome Measure Information:
Title
Percentage of time
Description
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.
Time Frame
through study completion, an average of 10 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Self-focused Attention in Depression

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