Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01589575
Other study ID # LOCAL/2012/CR-03
Secondary ID 2012-A00501-42
Status Completed
Phase N/A
First received April 30, 2012
Last updated March 30, 2015
Start date September 2012
Est. completion date January 2015

Study information

Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

The main objective of this study is to compare the rate of reported anxiety / depression (HADS >= 8) among spouses and other family members in ICU patients.


Description:

The secondary objectives of this study are:

- to assess symptoms of anxiety (HADS ≥ 8) and depression (HADS ≥ 8) among relatives of ICU patients three months after discharge

- to assess what relatives felt vis-à-vis the information process

- describe the number and duration of interviews with participants

- to compare variables between the groups "spouses" and "other relatives".

- satisfaction

- number and duration of interviews

- HADS questionnaire

- The scale Edmunton

- an internal questionnaire

- IES-R score

- level of mental well-being: WEMWBS

- to describe the completeness of the study

- to test the hypothesis that the development of symptoms related to physical manifestations of anxiety and depression predicts the development of post-traumatic stress at 3 months.

- to assess the impact of the various forms of stress during hospitalization.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- The relative must have given his/her informed and signed consent

- The relative must be insured or beneficiary of a health insurance plan

- The relative must be available for 3 months of follow-up

Exclusion Criteria:

- The relative is under judicial protection, under tutorship or curatorship

- The relative refuses to sign the consent

- It is impossible to correctly inform the relative

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
France CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire 3 months after the patients is discharged from the ICU unit No
Secondary * Presence/absence of a score >= 8 on the Hospital Anxiety and Depression Scale Questionnaire 4-6 days after the admission of a patient to the ICU No
Secondary VAS score for satisfaction concerning the communication of information concerning the patient currently in the ICU Visual Analog Scale ranging from 1 to 10 During the ICU stay (days 1 to 28) No
Secondary Number of interviews Number of interviews the relative has with medical staff During the ICU stay (days 1 to 28) No
Secondary Mean interview duration (minutes) During the ICU stay (days 1 to 28) No
Secondary Edmonton Symptom Assessment Scale Score 4-6 days after the admission of a patient to the ICU No
Secondary The Impact of Event Scale - Revised (IES-R) 3 months after the patients is discharged from the ICU unit No
Secondary The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) 3 months after the patients is discharged from the ICU unit No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
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