Depression Clinical Trial
— AQVAROfficial title:
Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures
Verified date | August 2016 |
Source | Centre Hospitalier of Chartres |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.
Status | Completed |
Enrollment | 1006 |
Est. completion date | December 31, 2016 |
Est. primary completion date | October 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: The same criteria of the IPREA3 study - Taken out alive of intensive care - Hospitalization in intensive care extending at least over three calendar days. Exclusion Criteria: - Deaths in intensive care - Age 18-year-old inferior - Under guardianship patient - Incompatible situation with the administration of the IPREA questionnaire at the exit of intensive care: presence of neuropsychic disorders, language barrier, transfer under mechanical ventilation, taken out of intensive care in urgency - Patient refused to participate in the study IPREA3 - Patient refused to participate in the study AQVAR |
Country | Name | City | State |
---|---|---|---|
France | C.H. de Chartres | Chartres | |
France | CHU Beaujon APHP | Clichy | |
France | CH Douai | Douai | |
France | CH La Rochelle | La Rochelle | |
France | CH Le Puy en Velay | Le Puy en Velay | |
France | CH Lens | Lens | |
France | CHU Edouard Herriot | Lyon | |
France | CHU Cochin APHP | Paris | |
France | CHU Saint Louis APHP | Paris | |
France | CHU Hautepierre | Strasbourg | |
France | CHU NHC | Strasbourg | |
France | CH Troyes | Troyes |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier of Chartres |
France,
Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CC — View Citation
Davydow DS, Zatzick D, Hough CL, Katon WJ. A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical-surgical intensive care unit admission. Gen Hosp Psychiatry. 2013 May-Jun;35(3):226-32. d — View Citation
Griffiths J, Fortune G, Barber V, Young JD. The prevalence of post traumatic stress disorder in survivors of ICU treatment: a systematic review. Intensive Care Med. 2007 Sep;33(9):1506-18. Epub 2007 Jun 9. Review. — View Citation
Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Mallédant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Me — View Citation
Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improve the reduction of depressive symptoms | A score 8 (maximal score of 21) allows to hold the presence of clinically significant depressive symptoms. | up to 52 weeks of the hospitalization | |
Secondary | Score of the sub-scale A of the questionnaire HAD-S ( Hospital and Anxiety Depression Scale) | Allowing to estimate the presence of anxious symptoms. Score of the sub-scale A of the questionnaire HAD-S one year after the exit of intensive care allowing to estimate the presence of anxious symptoms. A score 8 (maximal score of 21) allows to hold the presence of clinically significant anxious symptoms. The scale HAD contains 14 highly-rated items from 0 to 3. Seven questions relate to the anxiety ( total A) and seven others in the depressive dimension (total D), so allowing the obtaining of two scores, the maximal note of wich for each of them is 21. |
up to 52 weeks of the hospitalization | |
Secondary | Score IES-R ( impact of Events Scale-Revised) | Allowing to detect a risk of state of post traumatic stress. | up to 52 weeks of the hospitalization | |
Secondary | Questionnaire EQ-5D | Indicators of quality of life estimated by questionnaires EQ-5D | up to 52 weeks of the hospitalization | |
Secondary | Describe quality of life | Return home, taken by a professional activity, an existence of a psychiatric or psychological follow up, and a regular consumption of psychotropics | up to 52 weeks of the hospitalization | |
Secondary | Duration of hospitalization | Informations are in the medical bases statistic of each hospital | Consecutive to the hospitalization in intensive care |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |