NCT01959750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

September 23, 2013

Last Update Submit

October 9, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At the beginning , at the end and 6 months after the end of the intervention.

Secondary Outcomes (1)

  • Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.

    4 three-months time periods (cf. Description).

Other Outcomes (1)

  • Measurement of staff quitting their jobs

    At the end of the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: problem-based sessions

Control Group

NO INTERVENTION

Interventions

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

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all ICU caregivers rrom the University Hospital of Geneva

You may not qualify if:

  • refusals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopitals of Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Burnout, PsychologicalAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Bara Ricou, Professor

    University Hospitals of Geneva

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2013

First Posted

October 10, 2013

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

September 1, 2013

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations