Trial document




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  DRKS00014015

Trial Description

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Title

Otium in the hospital? A mindfulness-based intervention for resident physicians

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Trial Acronym

MDA

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URL of the Trial

https://www.sfb1015.uni-freiburg.de/en/subprojects/p-practices#p3

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Brief Summary in Lay Language

Background and Purpose: Work-related mental health problems are considerably more prevalent in hospital doctors during residency than in the general population. Residents suffer more often from burnout, depression or substance abuse and are at a higher risk to commit suicide than other academic professionals. Work factors contributing to ill health are a high work load, long working hours, a neglect of self-care and a widespread performance mentality.

Our intervention aims at enabling residents to meet their exceptional work challenges with more serenity and autonomy. The intervention consists of an eight-week mindfulness-based program that considers strategies especially relevant to the needs of hospital residents as well as a four-month maintenance phase consisting of monthly meetings.

Hypotheses:
We hypothesize that (1) the mindfulness intervention will have positive effects on resident´s self reported burnout, empathy, experience of stress, depression, anxiety, jobstrain, mindfulness, work satisfaction, self-worth, thriving, flourishing, life satisfaction, self-efficacy, emotional sensation, mental health, self-compassion, feeling loved, subjective passage of time, treatment errors, Muße (2) the mindfulness intervention will have positive effects on external assessments of residents through patients and colleagues; (3) the mindfulness intervention will have positive effects on implicit, behavioural, and physiological measures (hair cortisol).

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Brief Summary in Scientific Language

Background and Purpose: Work-related mental health problems are considerably more prevalent in hospital doctors during residency than in the general population. Residents suffer more often from burnout, depression or substance abuse and are at a higher risk to commit suicide than other academic professionals. Work factors contributing to ill health are a high work load, long working hours, a neglect of self-care and a widespread performance mentality.

Our intervention aims at enabling residents to meet their exceptional work challenges with more serenity and autonomy. The intervention consists of an eight-week mindfulness-based program that considers strategies especially relevant to the needs of hospital residents as well as a four-month maintenance phase consisting of monthly meetings.

Method: This is a randomized-controlled trial. 178 residents will be allocated to either an 8-week mindfulness intervention followed by a 4-month maintenance phase or the control group which receives a course book about mindfulness for self-study.

Hypotheses:
We hypothesize that (1) the mindfulness intervention will have positive effects on resident´s self reported burnout, empathy, experience of stress, depression, anxiety, jobstrain, mindfulness, work satisfaction, self-worth, thriving, flourishing, life satisfaction, self-efficacy, emotional sensation, mental health, self-compassion, feeling loved, subjective passage of time, treatment errors, Muße (2) the mindfulness intervention will have positive effects on external assessments of residents through patients and colleagues; (3) the mindfulness intervention will have positive effects on implicit, behavioural, and physiological measures (hair cortisol).

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Organizational Data

  •   DRKS00014015
  •   2018/05/24
  •   [---]*
  •   yes
  •   Approved
  •   361/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Subjects of the present study are a non-clinical sample that faces high work loads, long working hours, a neglect of self-care and a widespread performance mentality.
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Interventions/Observational Groups

  •   Residents randomly allocated to the intervention group will take part in an eight-week mindfulness course consisting of weekly sessions. Specifically, participants will learn a variety of mindfulness exercises (e.g. body scan, mindfulness of breath, mindful movements, walking meditation). Moreover, thematic emphasis have specifically been adapted to residents needs, including topics such as: otium, dealing with barriers, experience of time, desidentification, dealing with stress in a mindful way, self-care, and experiencing meaning in daily life. A central aspect of the intervention is the application and integration of mindfulness into ones work-routine and everyday life. After the eight-week intervention participants will take part in a four-month maintenance phase, consisting of monthly sessions aiming at refreshing the skills learned during the eight-week course.
  •   Residents randomly allocated to the control group will receive a course book about mindfulness for individual study. The individual chapters will be sent to participants on a weekly basis over the course of eight weeks.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Self-rated burnout using the Copenhagen Burnout Inventory will be assessed before the eight-week course (t0), after the course (t1), after the four-month maintenance phase (t2) as well as six months after the end of the maintenance phase (t3).

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Secondary Outcome

Participants will be assessed before the eight-week course (t0), after the course (t1), after the four-month maintenance phase (t2) as well as six months after the end of the maintenance phase (t3).

Self-report measures:

Burnout (Copenhagen Burnout Inventory - CBI), Empathy (Jefferson Scale of Physician Empathy - JSPE), Stress (Perceived Stress Scale - PSS), Depression (PHQ-4), Anxiety (PHQ-4), Jobstrain (Irritation), Mindfulness (Freiburger Fragebogen zur Achtsamkeit - FFA), Work Satisfaction (Kunin's Faces Scale), Self-Esteem (Single Item Self-Esteem Scale), Thriving (Thriving Scale), Flourishing (Flourishing Scale), Life Satisfaction (Kurzskala zur Erfassung der allgemeinen Lebenszufriedenheit -L1), Self-Efficacy (Allgemeine Selbstwirksamkeit Kurzskala - ASKU), emotional well-being (SAM face scale), mental health (General Health Questionnare - GHQ-12), Self-Compassion (Self-Compassion Scale - SCS), Feeling Loved (Feeling Loved Scale), Subjective Passage of Time (Subjecitve Time Questionnaire - STQ), Treatment Errors and Muße.

Qualitative Interviews:
Semi-structured interviews will be held between t1 und t2 with a subgroup of subjects. Topics of the iterview will be: Mindfulness, personal understanding of otium, relationship between otium and mindfulness, effects of mindfulness on stress, effects of mindfulness on the implementation and experience of leisure time and recreation, experience of meaning at work, and the effects of mindfulness on dealing with patients.

External assessments:
External assessment by colleagues regarding the following dimensions: tension, hurry, serenity, empathy, being mindfully present. External assessment by patients regarding the following dimensions: satisfaction with treatment, being mindfully present, competence, empathy, being caring.
Additionally sick leave will be assessed.

Implicit and objective measures: attitude to work with the single-category Implicit Association Test (Bluemke & Friese, 2008; Leavitt, Fong, & Greenwald, 2011), emotional state using the Implicit Positive and Negative Affect Test (IPANAT; Quirin, Kazen, & Kuhl, 2009), emotional state using the word fragment test (Gilbert & Hixon, 1991; Johnson et al., 2010), self-esteem using the Full-Name Name-Liking (Gebauer et al. 2008), attitude to work using the Affect Misattribution Procedure (AMP; Payne, Cheng, Govorun, & Stewart, 2005). Additionally, indices of stress will be assessed by tracking movement of mouse and keyboard. Finaly, cumulated haircortisol of the past month using a 1 cm long hair sample will be examined.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/09/10
  •   178
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

residents employed at a clinic with a minimum employment of 40%, regular contact with patients, good knowledge of German language

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Exclusion Criteria

Lack of willingness to fulfill the requirements of the study, participation in other work related studies, psychological and psychiatric condition impairing people-to-people contact, addiction

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Addresses

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    • Klinik für Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr.  Stefan  Schmidt 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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    • Albert-Ludwigs-Universität Freiburg, Institut für Psychologie, Wirtschaftspsychologie
    • Ms.  Prof. Dr.  Anja  Göritz 
    • Engelbergerstraße 41
    • 79085  Freiburg
    • Germany
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    • Klinik für Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr.  Stefan  Schmidt 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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    • Albert-Ludwigs-Universität Freiburg
    • Ms.  M.Sc.  Vanessa  Aeschbach 
    • Rheinstraße 10
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft e.V.
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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