Trial document




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  DRKS00003476

Trial Description

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Title

Relase prevention via videoconference after inpatient care in anorexia nervosa - a pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Anorexia nervosa (AN) is a severe mental disorder, which is asccompanied by substantial morbidity and mortality. Long-term course is characterized by recurrent relapses. While inpatient treatment in AN is mostly successful, 30 to 50% of patients lose weight very quickly after discharge. Central idea of the project is the offer of a novel health care concept which is supposed to bridge the gap between inpatient and outpatient care in an integrated longterm treatment concept for AN. This concept encompasses an intervention that aims at relapse prevention after inpatient care for AN which is delivered via videoconferencing allowing for the continuing care of patients from a large area. This concept is to be tested in the pilot study. Aims are the investigation of the need for such an intervention, feasablity and acceptance of the intervention and the teletherapy.

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Brief Summary in Scientific Language

Anorexia nervosa (AN) is a severe mental disorder, which is asccompanied by substantial morbidity and mortality. Long-term course is characterized by recurrent relapses. While inpatient treatment in AN is mostly successful, 30 to 50% of patients lose weight very quickly after discharge. Central idea of the project is the offer of a novel health care concept which is supposed to bridge the gap between inpatient and outpatient care in an integrated longterm treatment concept for AN. This concept encompasses an intervention that aims at relapse prevention after inpatient care for AN which is delivered via videoconferencing allowing for the continuing care of patients from a large area. This concept is to be tested in the pilot study. Aims are the investigation of the need for such an intervention, feasablity and acceptance of the intervention and the teletherapy.

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Organizational Data

  •   DRKS00003476
  •   2012/01/05
  •   [---]*
  •   yes
  •   Approved
  •   518/2011BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   F50.0 -  Anorexia nervosa
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Interventions/Observational Groups

  •   AN patients receive 10 sessions of a manualized relapse prevention (based on cognitive-behavioral therapy) after discharge from inpatient treatment via videoconferencing.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

need for, feasability and acceptance of the intervention

The primary endpoint will be assessed by interviews and self-report instruments at the end of intervention (4 months after beginning of the intervention).

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Secondary Outcome

relapse rate, health care utilization

The secondary endpoint will be assessed by weight measurement, interviews and self-report instruments at the end of intervention (4 months after beginning of the intervention).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/08/02
  •   16
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Full-syndrom or subsyndromal Anorexia nervosa according to ICD-10 (F50.0 or F50.1) at admission to inpatient treatment, regular completion of inpatient treatment, written informed consent

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Exclusion Criteria

Severe somatic disorder, current substance dependance, psychosis, current suicidal crisis, pregnancy or lactation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Tübingen
    • Ms.  Dr.  Katrin  Giel 
    • Osianderstr. 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Ms.  Dr.  Katrin  Giel 
    • Osianderstr. 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen
    • Ms.  Dr.  Katrin  Giel 
    • Osianderstr. 5
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Christina Barz Stiftung
    • 45239  Essen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/01
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Trial Publications, Results and other Documents

  •   Giel, K. E., et al. (2015). "Relapse Prevention via Videoconference for Anorexia Nervosa - Findings from the RESTART Pilot Study." Psychotherapy and Psychosomatics 84(6): 381-383.
  •   Giel, K. E., et al. (2013). "[Relapse prevention in anorexia nervosa]." Psychotherapie, Psychosomatik, Medizinische Psychologie 63(7): 290-295.
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