Trial document




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  DRKS00012823

Trial Description

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Title

Short-term, long-term and cost-effectiveness of treating depression and anxiety disorders in children and adolescents – 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

The current study will evaluate and compare the effectiveness of cognitive-behavioral and psychodynamic therapy. Therefore 420 children and adolescents (ages 8-16 years) with depression and/or anxiety disorder will be randomly assigned to a treatment or a control condition. The intervention´s short-term effectiveness and sustainability as well as cost-effectiveness will be examined over a 5 year period for each participant.

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Brief Summary in Scientific Language


This study aims to optimize patient-centered care and to ensure scientific and legal approval of cognitive-behavioral and psychodynamic therapy for children and adolescents in the German health-care system. This prospective, randomized and controlled trial will therefore compare psychodynamic and cognitive behavioral therapy with a low-frequency family intervention (control intervention) for children and adolescents with depression and anxiety disorder. Number of diagnoses or fulfilled diagnostic criteria - diagnosed by a trained psychologist who is blind for treatment condition as well as rated by patients and parents - will be the primary outcome. Secondary outcomes are patients´ and parents´ strain caused by symptoms, patients´ quality of life, global and family functioning and treatments´ cost effectiveness are secondary outcomes.
Patients will be recruited at the end of an inpatient hospital stay in northern Germany (Hamburg and Bremen). After gathering informed consent from parents and patients, the latter will be randomly assigned to one type of outpatient treatment (psychodynamic, cognitive behavioral therapy or family intervention). Psychodynamic and cognitive-behavioral therapy as well as the control intervention will be provided manual-based. Treatment sessions will be audio recorded to control adherence.
Data will be collected annually over a period of five years starting at the beginning of treatment. This allows examination of varying treatment intervals as well as the sustainability and health economics of therapy effects.
To analyze data, comparisons of means will be performed. Groupwise analyses of interaction will be performed for inferential testing of differences in subgroups. Differences in therapy effects will be inferentially analyzed by multifactor analysis of covariance, analysis of variance or logistic regression. Interaction effects and predicting variables are of special interest.
In a Subsample of 32 depressive adolescents (ages 13-16) patients expectations before and experiences whilst therapy will be analyzed by a mixed-methods-approach.

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Organizational Data

  •   DRKS00012823
  •   2017/09/27
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  •   yes
  •   Approved
  •   PV5560, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1202-1831 
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Health Condition or Problem studied

  •   F30-F39 -  Mood [affective] disorders
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F42 -  Obsessive-compulsive disorder
  •   Depression and/or anxiety disorder
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Interventions/Observational Groups

  •   outpatient psychodynamic psychothrapy in single patient setting, therapy frequnency and duration depend on indication
  •   oupatient cognitive behavioral therapy in single patient setting, therapy frequnency and duration depend on indication
  •   psychodynamic family intervention (control condition):
    low-frequency family intervention with 6-8 sessions over a period of 6 months according to CHIMPs-concept
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Characteristics

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

Number of psychiatric diagnoses respectively number of diagnostic criteria will be assessed by Kiddie-SADS interview (Delmo et al., 2001). The Kiddie-SADS interview will be conducted by a trained rater external to the project before treatment henceforth annually over a 5 year period for each child.

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Secondary Outcome

Children´s depressive symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of
the german version of the "Children´s depression inventory" (Depressionsinventar für Kinder und Jugendliche (DIKJ;
Stiensmeier-Pelster, Schürmann, & Duda, 2000) before therapy starts and henceforth annually over a five year period.
Children´s anxiety symptomatology will be assessed by children´s (aged 10 years and older) and parents´ rating of
the german version of the "Screen for child anxiety related emotional disorders" (Scared; Birmaher, Khetarpal, Cully,
Brent, & McCanzie, 1995) before therapy starts and henceforth annually over a five year period.
Cildren´s psychiatric disorders will further be assessed by parents´ rating of the german version of the "Child behavior
checklist" (CBCL; Achenbach, 1991) before therapy starts and henceforth annually over a five year period.
Cildren´s psychiatric disorders will further be assessed by children´s (aged 10 years and older) rating of the german
version of the "Youth self report" (YSR; Achenbach, 1991) before therapy starts and henceforth annually over a five year period.
Children´s structural functioning will be assessed by self-report (children and adolescents aged 10 years and older)
using the german structure questionnaire for the "Operationalized psychodynamic diagnostic for children and
adolescents" (OPD-KJ2-SF, Schrobildgen et al., 2017) before therapy starts and henceforth annually over a five year period.
Children´s health related quality of life will be assessed by children´s (aged 10 years and older) and parents´ rating of
the german version of the Kidscreen (Ravens-Sieberer & the European KIDSCREEN group, 2006) before therapy starts and henceforth annually over a five year period.
Children´s global impairment will be assessed by a trained rater external to the project using the german "Skala zur
Gesamtbeurteilung von Kindern und Jugendlichen" (SGKJ; Steinhausen, 1985) before therapy starts and henceforth annually over a five year period.
Families´ relational functioning will be rated by a trained rater external to the project using the german version of the
"Global assessment of relational functioning scale" (GARF; Saß, Wittchen, & Zaudig, 1996) before therapy starts and henceforth annually over a five year period.
Children´s global functioning will be rated by a trained rater external to the project using the german version of the
"Global assessment functioning scale" (GAF; American Psychiatric Association, 2000) before therapy starts and henceforth annually over a five year period.
Health economics will be assessed by a trained rater external to the project using the german version of the "Children
and adolescent mental health services receipt inventory" (CAMHSRI-EU; Kilian et al., 2009) before therapy starts and henceforth annually over a five year period.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
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Recruitment

  •   Planned
  •   2017/09/28
  •   420
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   16   Years
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Additional Inclusion Criteria

diagnosis of a depressive disorder (ICD-10; F30-F39) or an anxiety
disorder (ICD-10; F40-F42)
informed consent (patients and parents)

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Exclusion Criteria

psychotic disorders, eating disorders, substance use related disorders
(except caffeine and nicotine), autism spectrum disorders, mutism,
personality disorders
neurologic disorders
severe mental retardation (filling out questionnaires and interview are not
feasible)
low command of the german language

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Grefe
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Prof. Dr.  Silke  Wiegand-Grefe 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Vereinigung Analytischer Kinder- und Jugendlichen-Psychotherapeuten in Deutschland e.V (VAKJP)
    • Kurfürstendamm 72
    • 10709  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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