Trial document




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  DRKS00006870

Trial Description

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Title

Cognitive Remediation Therapy in Anorexia nervosa - a randomized controlled trial

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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 serious mental disorder with high morbidity and lifetime mortality. Treatment response is typically low in this population and many patients show a chronic course of the disorder. Certain neurobiological and neurocognitive alterations seem to impede treatment response in AN. Particularly, cognitive flexibility plays an important role in the maintenance of the disorder. In order to address this cognitive inefficiency, a specific treatment module has been developed, the so-called Cognitive Remediation Therapy (CRT) for AN. In a pilot study, we were able to show that CRT can foster cognitive flexibility in AN patients. Furthermore, patients in this study showed high treatment acceptance. In a next step, we want to examine whether the implementation of a CRT module into standard inpatient treatment for AN leads to better treatment outcomes. Therefore, the present study compares CRT to a control condition (art therapy) that is equal in format, dose, and frequency. We expect that CRT leads to stronger and faster decreases in AN symptoms and increases in cognitive flexibility than the control condition.

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Brief Summary in Scientific Language

Anorexia nervosa (AN) is a serious mental disorder with high morbidity and lifetime mortality. Treatment response is typically low in this population and many patients show a chronic course of the disorder. Certain neurobiological and neurocognitive alterations seem to impede treatment response in AN. Particularly, cognitive flexibility (set-shifting) plays an important role in the maintenance of the disorder. In order to address this cognitive inefficiency, a specific treatment module has been developed, the so-called Cognitive Remediation Therapy (CRT) for AN. In a pilot RCT, we were able to show that CRT fosters cognitive flexibility in AN patients. Furthermore, patients in this study showed high treatment acceptance. In a next step, we want to examine whether the implementation of a CRT module into standard inpatient treatment for AN leads to better treatment outcomes. Therefore, the present study compares CRT to a control condition (i.e. art therapy) that is equal in format, dose, and frequency. We expect that CRT leads to stronger decreases in AN symptoms and stronger increases in AN-related quality of life (primary outcome) as compared to the control condition. Furthermore, we expect that patients in the CRT group show similar treatment acceptance like patients in the control group. Finally, we expect that CRT leads to greater increases in cognitive flexibility than the control treatment.

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Organizational Data

  •   DRKS00006870
  •   2015/02/17
  •   [---]*
  •   yes
  •   Approved
  •   S-031/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F50.0 -  Anorexia nervosa
  •   F50.1 -  Atypical anorexia nervosa
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Interventions/Observational Groups

  •   Treatment as usual (TAU) + Cognitive Remediation Therapy (CRT) for AN (group format, 1 session per week, 100 min. each, over 10 weeks)

    *CRT belongs to the so-called neurobehavioral treatment approaches that aim at improving specific neurocognitive functions by adopting certain cognitive-behavioral tasks. Improving such basic functions of cognitive control may
    enhance the patients’ responsiveness to consecutive psychotherapeutic treatments.

    CRT for anorexia nervosa is specifically tailored to the basic neurocognitive functions that are assumed to play an important role in the etiology of the disorder (mainly cognitive set-shifting and global processing).

    Within CRT, patients conduct several paper+pencil based tasks and transfer there experiences to their daily routines and thinking styles. With continuous training and behavioral experiments, patients can enhance their cognitive flexibility and global processing and transfer this to other aspects in their lives.
  •   Treatment as usual (TAU) + art therapy* (group format, 1 session per week, 100 min. each, over 10 weeks)

    * In Germany and other countries as well, art therapy represents an established component of integrative psychosomatic, psychiatric, and psychotherapeutic inpatient care for people with mental disorders. Via working with art media (e.g. painting, drawing, sculpting, photography) patients can expressive inner and outer pictures, develop and refine creative skills, search for problem solutions and train their sense perception. Furthermore, art therapy provides a range of possibilities to conduct pleasant activities that may help to foster mood and self-esteem via positive reinforcement.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Body Mass Index, total score in the Eating Disorder Examination Questionnaire and total score in the Eating Disorders Quality of Life Questionnaire 6 months after treatment

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Secondary Outcome

Body Mass Index, total score in the Eating Disorder Examination Questionnaire and total score in the Eating Disorders Quality of Life Questionnaire 10 weeks after first treatment session; cognitive flexibility as assessed by the Wisconsin Card Sorting Test, the Trail Making Test and the Detail and Flexibility Questionnaire 10 weeks after first treatment session; Drop-out rate 10 weeks after first treatment session; treatment acceptance as measured by an evaluation form 10 weeks after first treatment session

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/06/02
  •   168
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   17   Years
  •   no maximum age
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Additional Inclusion Criteria

DSM-V diagnosis of AN, indication for inpatient treatment

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Exclusion Criteria

acute life-threatening conditions; medical instability; severe psychiatric comorbidity (i.e. schizophrenia, bipolar disorder, organic mental disorder)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik Lüneburger Heide
    • Ms.  Dr.  Wally  Wünsch-Leiteritz 
    • Am Klaubusch 21
    • 29549  Bad Bevensen
    • Germany
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    • Universitätsklinik Heidelberg, Klinik für Allgemeine Innere Medizin und Psychosomatik
    • Mr.  Dr.  Timo  Brockmeyer 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Klinik Lüneburger Heide
    • Ms.  Dr.  Wally  Wünsch-Leiteritz 
    • Am Klaubusch 21
    • 29549  Bad Bevensen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik Lüneburger Heide
    • Ms.  Dr.  Wally  Wünsch-Leiteritz 
    • Am Klaubusch 21
    • 29549  Bad Bevensen
    • 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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* This entry means the parameter is not applicable or has not been set.