Trial document




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  DRKS00004644

Trial Description

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Title

Pilot study: Expressive writing during the waiting time for ambulant psychotherapy in patients with physical diseases and mental comorbidity

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Trial Acronym

SES

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This pilot study is conducted by the psychotherapeutic outpatient center for mental disorders in patients with a physical disease at the Institute of Psychology at the University of Freiburg, Germany. The study is concerned with the influences of Expressive Writing about distressing life-events on well-being and health. Empirical studies show that writing in a structured manner about distressing and emotionally disturbing life-events is helpful for many people. This method is termed Expressive Writing.
In our study we are interested in both the subjective impressions and experiences of persons during writing and the associations between Expressive Writing and psychological and physical stress. Subjects are randomized in one of two groups which differ in the point in time Expressive Writing is conducted. One group accomplishes the writing project during the days after a first diagnostic session, the other group has the opportunity to accomplish the writing project six weeks later. The first group conducts the four-day writing project by means of a workbook on arbitrary days within the first ten days after the diagnostic session. A questionnaire is to be completed on a fifth day which should be sent back to the investigators together with the workbook in an annexed postage free envelope. The writing session will last 30 minutes each day as will the completion of the questionnaire at day five. The written texts of the writing project are personal for the writers. The texts can be resent to the investigator voluntarily without any feedback on the texts. Four weeks after completion of the writing project the subjects will be sent another questionnaire, which should also be filled out and resent. The second group obtains also questionnaires to be completed two and six weeks after the initial session. Afterwards the subjects of this group can also take part in the writing project by means of the workbook as explained above and provide the investigators with parts of or all of their texts voluntarily. If necessary the subjects are reminded by phone or e-mail to send back the study materials.

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Brief Summary in Scientific Language

This pilot study investigates the Expressive Writing technique, which is applicable without much effort and which may be suitable to make effective use of waiting times in outpatient psychotherapy. Up to now, Expressive Writing remains unmentioned in the literature and research about waiting times. The aim of this pilot study is to examine the feasibility, acceptance and effectiveness of Expressive Writing in an outpatient setting. Expressive Writing is introduced as a meaningful method during the waiting times of patients with physical diseases and psychiatric comorbidity. Persons seeking help from the psychotherapeutic ambulance outpatient centre for mental disorders in patients with a physical disease at the Institute of Psychology at the University of Freiburg, Germany, can take part in the study during their waiting time for treatment after a first diagnostic session. In the long run the results of this study can add to the improvement of patient-care. Particularly, the bypass of waiting times and the prevention of their negative consequences could be possible benefits of Expressive Writing.

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Organizational Data

  •   DRKS00004644
  •   2013/02/13
  •   [---]*
  •   yes
  •   Approved
  •   17/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F54 -  Psychological and behavioural factors associated with disorders or diseases classified elsewhere
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F41 -  Other anxiety disorders
  •   F43 -  Reaction to severe stress, and adjustment disorders
  •   Subjects with physical diseases and mental comorbidity, chapter F3, F4 and F5 (ICD-10).
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Interventions/Observational Groups

  •   Intervention group: Patients of the psychotherapeutic outpatient centre for mental disorders in patients with a physical disease accomplish a four-day Expressive Writing project immediately after a first diagnostic session. By the means of questionnaires physical and psychological health is measured before the first session, right after the writing project and again approximately six weeks after the initial session. Besides, the subjective impressions and experiences of the writers are measured after each writing session and in summary at the end of the writing project via questionnaires.
  •   Control group: Patients of the psychotherapeutic outpatient centre for mental disorders in patients with a physical disease are consulted about their physical and psychological health via questionnaire before a first diagnostic session and two and six weeks later. Afterwards the subjects can also accomplish a four-day Expressive Writing project (see intervention group).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Endpoint Hypothesis 1: Proportion of subjects, who can accomplish the expressive writing project without problems at home during the waiting time for ambulant psychotherapy.

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Secondary Outcome

Endpoint Hypothesis 2: Selfreports both directly after the writing sessions and at the end of the writing project (using questionnaires from Niedtfeld, Schmidt & Scholz, 2008, and Pennebaker, 2010).

Niedtfeld, I., Schmidt, A.F. & Scholz, O.B. (2008). Wie wirkt Expressives Schreiben? Differenzielle Wirkfaktoren des Schreibens über belastende Lebensereignisse. Verhaltenstherapie, 18, 91-99.
Pennebaker, J.W. (2010). Heilung durch Schreiben. Ein Arbeitsbuch zur Selbsthilfe. Bern: Hans Huber.

Endpoint Hypothesis 3: Selfreport questionnaires targeting different aspects of physical and psychological health (SF-12, Bullinger & Kirchberger, 1998; BAI, Margraf & Ehlers, 2007; BDI II, Hautzinger, Keller & Kühner, 2006; BSI, Franke, 2000; PANAS, Krohne, Egloff, Kohlmann & Tausch, 1996; PSS, Cohen & Williamson, 1988; FLZ, Fahrenberg, 2000; VEV, Zielke & Kopf-Mehnert, 1978).).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/02/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients of the psychotherapeutic outpatient centre for mental disorders in patients with a physical disease (University of Freiburg). Patients are recruited after a first diagnostic session. All patients suffer from a physical disease and mental comorbidity and are waitlisted.

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Exclusion Criteria

Not included are patients who 1) are unable to write continuously in German for 20 minutes, 2) have a history of trauma, making expressive writing too stressful, 3) do not have a mental disorder, 4) have cognitive disabilities or 5) are currently suicidal.

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Addresses

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    • Psychotherapeutische Hochschulambulanz für psychische Störungen bei körperlichen Erkrankungen, Albert-Ludwigs-Universität Freiburg, Institut für Psychologie, Abteilung für Rehabilitationspsychologie und Psychotherapie
    • Mr.  Prof. Dr. Dr.  Jürgen  Bengel 
    • Engelbergerstr. 41
    • 79085  Freiburg
    • Germany
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    • Psychotherapeutische Hochschulambulanz für psychische Störungen bei körperlichen Erkrankungen, Albert-Ludwigs-Universität Freiburg, Institut für Psychologie, Abteilung für Rehabilitationspsychologie und Psychotherapie
    • Ms.  Dr.  Katharina  Kufner 
    • Engelbergerstr. 41
    • 79085  Freiburg im Breisgau
    • Germany
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  • start of 1:1-Block address public-contact
    • Psychotherapeutische Hochschulambulanz für psychische Störungen bei körperlichen Erkrankungen, Albert-Ludwigs-Universität Freiburg, Institut für Psychologie, Abteilung für Rehabilitationspsychologie und Psychotherapie
    • Ms.  Dr.  Katharina  Kufner 
    • Engelbergerstr. 41
    • 79085  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Psychotherapeutische Hochschulambulanz für psychische Störungen bei körperlichen Erkrankungen, Albert-Ludwigs-Universität Freiburg, Institut für Psychologie, Abteilung für Rehabilitationspsychologie und Psychotherapie
    • Mr.  Prof. Dr. Dr.  Jürgen  Bengel 
    • Engelbergerstr. 41
    • 79106  Freiburg im Breisgau
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/24
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Trial Publications, Results and other Documents

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