Trial document





This trial has been registered retrospectively.
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  DRKS00021518

Trial Description

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Title

Effectiveness of Usual-Care Cognitive-Behavioral Therapy for Adolescents with Depressive Disorders Rated by Parents and Patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Changes during outpatient cognitive-behavioral therapy of adolescents with depressive disorders were analyzed in self- and parent raing.

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Brief Summary in Scientific Language

Depressive disorders are common in adolescence and are associated with a wide range of negative long-term outcomes. Highly controlled randomized controlled trials (RCT) provide considerable evidence for the efficacy of cognitive-behavioral therapy (CBT) as a treatment for depression, but the effectiveness of CBT under routine care conditions remains unproven. In the present observational study, the changes achieved through routine CBT in adolescents with depressive disorders treated in a university outpatient clinic were analyzed, and compared to a historical control group of adolescents with depressive disorders who had received treatment as usual.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00021518
  •   2020/04/27
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  •   yes
  •   Approved
  •   15-401, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   cognitive-behavioral therapy
  •   historical control group
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Treatment
  •   Other
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  •   N/A
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Primary Outcome

2 assessment points: treatment begin and end;

standardized questionnaires in parent and self rating assessing depressive symptoms (FBB-DES and SBB-DES from the DISYPS-3)

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Secondary Outcome

2 assessment points - treatment begin and end;
standardized questionnaire assessing multiple mental symptoms in parent and self rating

Child behavior Checklist (CBCL)
Youth self Report (YSR)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/01/01
  •   331
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

(1) age 11-18 years, (2) fulfillment of the ICD-10 criteria for any depressive disorder (depressive episode, recur-rent depressive disorder, dysthymia, depressive conduct disorder, adjustment disorder with depressed mood, mixed anxiety and depressive disorder), (3) clinically relevant impairment based on clinical judgment, (4) ability to attend treatment appointments once per week, and (5) a positive prognosis for outpatient treatment

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Exclusion Criteria

The exclusion criteria were severe use of alcohol or other drugs and an indication for inpatient treatment.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Köln AKiP
    • Mr.  PD Dr.  Daniel  Walter 
    • Pohligstr.
    • 50969  Köln
    • Germany
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    • Uniklinik Köln, AKiP
    • Mr.  PD Dr.  Daniel  Walter 
    • Pohligstr. 9
    • 50969  Köln
    • Germany
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    • Uniklinik Köln AKiP
    • Mr.  PD Dr.  Daniel  Walter 
    • Pohligstr.
    • 50969  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln AKiP
    • Mr.  PD Dr.  Daniel  Walter 
    • Pohligstr.
    • 50969  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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Trial Publications, Results and other Documents

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