NCT01082497

Brief Summary

The purpose of this study is to investigate whether a mindfulness based 8-week course for stress reduction, known as MBSR course, given to all staff at an inpatient psychiatric ward influences the level of stress and burnout and the psychosocial atmosphere at the ward. The design is an intervention trial with repeated measures and control group.The focus is the interaction between unit and individuals. All staff at both wards were invited to participate. The intervention consists of 8 weekly group meetings where the participants learn different ways of practicing mindfulness and do home practice between the meetings. The control intervention is 8 weekly workshops in affect-consciousness. Data are collected through self-reporting questionnaires on mindfulness, work- and health-related topics at six different points. The patients at both wards answers one questionnaire about ward atmosphere at the same points. Data wil be analyzed on SPSS statistic programme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2009

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

May 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

March 5, 2010

Last Update Submit

April 11, 2012

Conditions

Keywords

MindfulnessStressBurnoutWard atmosphereStress and burnout among staff, psychosocial atmosphere at the ward

Outcome Measures

Primary Outcomes (1)

  • The ability of mindfulness measured by the Five Facet Mindfulness Questionnaire

    The questionnaire measure the ability to observe, describe and act with awareness,nonreactivity and non-judgemental awareness.

    Three months before to one year follow up after the intervention

Secondary Outcomes (1)

  • The amount of work stress and burnout measured with The Maslach Burnout Inventory

    Three months before intervention to one year follow up after the intervention

Study Arms (2)

Mindfulness

EXPERIMENTAL
Behavioral: Mindfulness training

Education

ACTIVE COMPARATOR

8 - weekly workshops on affect consciousness for all staff

Behavioral: Mindfulness training

Interventions

A course in mindfulness based stress reduction with 8 weekly group meetings and home practice between the meetings. Each meetings last for 90 minutes. Participants get workbook and cds to support home practice.

Also known as: MBSR
EducationMindfulness

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all staff working at the ward 50 % or more, not attending to leave during the first year.

You may not qualify if:

  • Staff working less than 50%, planned to leave before one year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North-Norway

Tromsø, Troms, 9291, Norway

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Tordis Sorensen Hoifodt, dr med. phd

    University Hospital of North Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2010

First Posted

March 8, 2010

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations