NCT02825004

Brief Summary

The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

July 4, 2016

Last Update Submit

January 31, 2018

Conditions

Keywords

BurnoutHealth Care WorkersCoping SkillsClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2)

    At the baseline (T0), 6 months (T1) and 12 months (T2)

Secondary Outcomes (2)

  • Changes in coping strategies as assessed by the Coping Orientation to Problems Experienced (COPE) (Carver et al., 1989) between baseline (T0), 6 months (T1) and 12 months (T2)

    At the baseline (T0), 6 months (T1) and 12 months (T2)

  • Changes in psychological symptoms as assessed by the Symptom Checklist-90-R (Prunas et al., 2012) between baseline (T0), 6 months (T1) and 12 months (T2)

    At the baseline (T0), 6 months (T1) and 12 months (T2)

Study Arms (2)

Psychological Intervention

EXPERIMENTAL

All the professionals workers involved in the experimental group will attend three intensive psychological meetings about emotional exhaustion, depersonalisation, low personal accomplishment and how to improve coping skills.

Behavioral: Psychological Intervention

Control Group

NO INTERVENTION

There is not any intervention.

Interventions

Psychological Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Doctors, physiotherapists, nurses and care workers
  • Be a Professional Worker at the Rehabilitation Respiratory Unit
  • Age \> 18 years old

You may not qualify if:

  • Refusal at the Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paolo Banfi

Milan, 20148, Italy

Location

Related Publications (3)

  • Prunas A, Sarno I, Preti E, Madeddu F, Perugini M. Psychometric properties of the Italian version of the SCL-90-R: a study on a large community sample. Eur Psychiatry. 2012 Nov;27(8):591-7. doi: 10.1016/j.eurpsy.2010.12.006. Epub 2011 Feb 21.

  • Kleijweg JH, Verbraak MJ, Van Dijk MK. The clinical utility of the Maslach Burnout Inventory in a clinical population. Psychol Assess. 2013 Jun;25(2):435-41. doi: 10.1037/a0031334. Epub 2013 Jan 28.

  • Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations