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Psychological Intervention on Burnout in ICU Caregivers

Primary Purpose

Burnout, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
problem-based sessions
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all ICU caregivers rrom the University Hospital of Geneva

Exclusion Criteria:

  • refusals

Sites / Locations

  • University Hopitals of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries.
Anxiety (HA) and depression (HD) were identified by the validated French version of the Hospital Anxiety and Depression Scale (HADS), which is composed of 14 items, self-rated using a 4-point Likert scale (0 to 3). The sub-scale scores of anxiety and depression range respectively from 0 to 7 (no distress), 8 to 10 (borderline), 11 to 15 (significant) and 16 to 21 (severe distress). Burnout was evaluated using the Maslach Burnout Inventory (MBI) in its Fontaine French version; it is composed of 22 questions on a 7-point Likert scale (0 to 6). This tool measures the 3 dimensions of burnout independently: emotional exhaustion, depersonalisation, and personal accomplishment. Scores of ≥ 27, ≥ 10, or ≤33 respectively for the 3 dimensions, can be a sign of burnout. A severe burnout can also be defined as the cumulated score of MBI of > -9.

Secondary Outcome Measures

Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.
ICU activities and absenteeism were analysed during 4 three-month time periods, i.e. 3 months before [Before] (January to March 2009), 3 months during [During] (randomly picked out as September and November 2009, and January 2010), 3 months following the end of the intervention [After] (April to June 2010) and from 7 to 10 months after intervention [At 6 months] (November, December 2010 and January 2011). Absenteeism was defined as the number of caregivers absent at least once per time period, independently of the duration of the absence.

Full Information

First Posted
September 23, 2013
Last Updated
October 9, 2013
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT01959750
Brief Title
Psychological Intervention on Burnout in ICU Caregivers
Official Title
Psychological Intervention on Burnout in ICU Caregivers: a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised controlled intervention aimed at reducing such distresses had been run until now. This study allowed finding a new method of psychological support applicable in the special environment of ICU. Our findings suggest that psychologists specifically assigned to treat ICU caregivers might be beneficial on their burnout.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
problem-based sessions
Intervention Description
weekly sessions for small groups of caregivers, led by two psychologists acting as moderators and using a systemic approach, as suggested in other peer-support groups using a problem-based method
Primary Outcome Measure Information:
Title
Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries.
Description
Anxiety (HA) and depression (HD) were identified by the validated French version of the Hospital Anxiety and Depression Scale (HADS), which is composed of 14 items, self-rated using a 4-point Likert scale (0 to 3). The sub-scale scores of anxiety and depression range respectively from 0 to 7 (no distress), 8 to 10 (borderline), 11 to 15 (significant) and 16 to 21 (severe distress). Burnout was evaluated using the Maslach Burnout Inventory (MBI) in its Fontaine French version; it is composed of 22 questions on a 7-point Likert scale (0 to 6). This tool measures the 3 dimensions of burnout independently: emotional exhaustion, depersonalisation, and personal accomplishment. Scores of ≥ 27, ≥ 10, or ≤33 respectively for the 3 dimensions, can be a sign of burnout. A severe burnout can also be defined as the cumulated score of MBI of > -9.
Time Frame
At the beginning , at the end and 6 months after the end of the intervention.
Secondary Outcome Measure Information:
Title
Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.
Description
ICU activities and absenteeism were analysed during 4 three-month time periods, i.e. 3 months before [Before] (January to March 2009), 3 months during [During] (randomly picked out as September and November 2009, and January 2010), 3 months following the end of the intervention [After] (April to June 2010) and from 7 to 10 months after intervention [At 6 months] (November, December 2010 and January 2011). Absenteeism was defined as the number of caregivers absent at least once per time period, independently of the duration of the absence.
Time Frame
4 three-months time periods (cf. Description).
Other Pre-specified Outcome Measures:
Title
Measurement of staff quitting their jobs
Description
We identified how many persons had quitted the ICU between the beginning and the end of the intervention (inclusion time).
Time Frame
At the end of the intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all ICU caregivers rrom the University Hospital of Geneva Exclusion Criteria: refusals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bara Ricou, Professor
Organizational Affiliation
University Hospitals of Geneva
Official's Role
Study Director
Facility Information:
Facility Name
University Hopitals of Geneva
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

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Psychological Intervention on Burnout in ICU Caregivers

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