CClinicalTrials.gg
CompletedNCT04423809AFPUpdated Jun 9, 2020

Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study

An observational study in The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members, sponsored by Centre hospitalier de Ville-Evrard, France. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by Centre hospitalier de Ville-Evrard, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
161
Ages
18 Years and older
Sex
All
01

Study summary

Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.

Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.

02

Conditions studied

  • The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members

Keywords

  • Psychiatry Nurse Burden Caregiver
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 161 is below the median of 200 across 480 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Centre hospitalier de Ville-Evrard, France is the lead sponsor of 22 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

caregiver of patient hospitalised in psychiatry

Inclusion criteria

  • Family members or relatives
  • Over 18 years
  • Having a relative

    • First hospitalized in psychiatry or hospitalized in psychiatry within 5 years
    • Over 18 years of age
    • Psychotic episode
    • Having been informed of their participation in this study
  • In regular contact with the patient prior to hospitalization, at least 4 hours per week.
  • French language
  • Signed written informed consent.

Exclusion criteria

Exclusion Criteria:

-Psychiatric pathology of another family member than the hospitalized.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • caregivers of adult patients hospitalized in psychiatry

    a face-to-face interview with a nurse and self-assessment scales.

    Other: clinical assessment

Interventions

  • Otherclinical assessment

    assessment of caregivers suffering when a family member is hospitalized

    Also known as: Interview

06

What researchers measure

Primary outcomes

  1. Center for Epidemiologic Studies-Depression scale

    is a simple tool for assessing depressive symptomatology for the general population

    Time frame: at patient admission

Secondary outcomes

  1. Zarit burden inventory

    to assess burden

    Time frame: at patient admission

  2. Short form 36

    To assess quality of life

    Time frame: at patient admission

  3. Semi-directional interview

    It consists of five items: subjective feeling, quality of life, social life, mood of the caregiver.

    Time frame: At patient admission

07

Study locations

1 site
  • Unité de recherche clinique
    Neuilly Sur Marne, Île De France 93330, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04423809
Lead sponsor
Centre hospitalier de Ville-Evrard, France
Responsible party
Januel (head of the clinical research unit, Centre hospitalier de Ville-Evrard, France) — Principal investigator
First posted
Jun 9, 2020
Start date
Jun 10, 2015
Primary completion
Jun 8, 2018
Completion
Mar 27, 2020
Last update
Jun 9, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion