- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674580
Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas (AQUARIUM)
September 14, 2018 updated by: Centre Hospitalier René Dubos
The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study consists in testing two big general hypotheses:
- In the first place, that suicidals presents a mental load (cognitive saturation) and an activity pain behaviour of their space of the thought by extremely painful peripheral cognitive movements (impression that the brain is saturated of thoughts, turbulences, internal movements)
- Secondly, that suicidals produces a surplus of representations of action, such takes out that their vision of the world is saturated of a not integrable kinaesthetic imaging by the subject.
Study Type
Observational
Enrollment (Actual)
67
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
-
-
Val d'Oise
-
Pontoise, Val d'Oise, France, 95300
- CH René Dubos
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Suicidal patients followed at the Hospital Rene Dubos
Description
Inclusion Criteria:
- Patients followed within the framework of an ambulatory follow-up post-emergencies(post-urgent matters).
- Knowledge of the French language
- patient who have signed of the form of consent,
- patient presenting one anxio-depressive disorder(confusion) with or without suicidal episode.
Exclusion Criteria:
- Not compatible health with the signing of the protocol,
- the not knowledge of the French language,
- patient who have refused the protocol.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suicidal patients
No intervention.
Follow-up of the suicidal patients
|
No intervention.
Follow-up of the suicidal patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental load (calm or turbulence of the spirit) - test of the aquarium
Time Frame: 5 days
|
To assess the calm or the turbulence of the spirit of the participant, the investigator will make him take the test of the aquarium.
The participant will perform an exercise to assess the load and movement of his thoughts.
The participant must imagine that the aquarium reflects the content of his mind.
The fish are the thoughts and the waves represent the turbulences and movements of all these thoughts.
Some subjects, for example, play about with the size of the fish ("it is only a single large fish, but it takes over my entire head"), the shape of the fish ("these fish are pointed because they are bad"), scrawl (the participant scrawled on the aquarium to say that his head was overrun), the projection of feelings ("those fish there are sad") or made digressive but interesting comments ("the wavy lines carry away the fish...").
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moral pain - Analog Visual Scale Battery
Time Frame: 5 days
|
In order to evaluate the participant's moral pain, the investigator proposes to answer the questions of a test titled Analog Visual Scale Battery.
It is in the form of a horizontal bar with left a peaceful state (mental pain not strong at all...) and conversely, on the right are the opposite feelings corresponding to a moral pain (very strong mental pain).
The participant is asked to check on the bar the level that most seems to reflect his feelings or impressions related to his moral pain.
|
5 days
|
|
Suicidal thoughts - Analog Visual Scale Battery
Time Frame: 5 days
|
In order to evaluate the participant's situation, the investigator proposes to answer the questions of a test titled Analog Visual Scale Battery.
It is in the form of a horizontal bar with left a peaceful state (example: calm thoughts, slight suicidal ideation ...) and conversely, on the right are the opposite feelings corresponding to a tormented state (example: many thoughts, suicidal ideation ...).
The participant is asked to check on the bar the level that most seems to reflect his feelings or impressions related to his suicidal ideation.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: BAUDOIN Thierry, PH, Rene Dubos Hospital
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
May 1, 2015
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
September 13, 2016
First Submitted That Met QC Criteria
September 14, 2018
First Posted (ACTUAL)
September 17, 2018
Study Record Updates
Last Update Posted (ACTUAL)
September 17, 2018
Last Update Submitted That Met QC Criteria
September 14, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD1515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.