Trial document




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  DRKS00004787

Trial Description

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Title

Developmentally Adapted Cognitive Processing Therapy for Adolescents and Young Adults with PTSD Symptoms after Physical and Sexual Abuse

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Trial Acronym

D-CPT

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URL of the Trial

http://www.traumatherapie-jugendliche.de/

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Brief Summary in Lay Language

We aim to study an intervention for Posttraumatic Stress Disorder (PTSD) related to sexual and/or physical abuse (SA/PA). Therefore, parts of different treatments were extracted and combined into a new intervention specially adapted for adolescents and young adults. This programme is called developmentally adapted Cognitive Processing Therapy (D-CPT; Matulis, Resick, Rosner & Steil, in prep). It has been successfully evaluated in a pilot study (Matulis, Resick, Rosner & Steil, 2013).
To evaluate the treatment’s efficacy, half of the patients is assigned to the D-CPT and the other half to the TAU-condition (Treatment as Usual = treatment which adolescents usually receive in the German health system).
Participation in our study is possible for adolescents and young adults (14 to 21 years old) who suffer from PTSD after SA/PA.

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Brief Summary in Scientific Language

We aim to evaluate a developmentally adapted Cognitive Processing Therapy (D-CPT; Matulis, Resick, Rosner & Steil, in prep) for Posttraumatic Stress Disorder (PTSD) after sexual and/or physical abuse (SA/PA) in adolescents and young adults. It is based on the Cognitive Processing Therapy (CPT; Resick, Monson & Chard, 2008) – an intervention that has been proven to be very effective for adults. Developmental adaptations concern emotion processing, therapy format and addressing typical developmental tasks. The D-CPT has already been successfully piloted: Nearly all of the participating patients showed improvement (Matulis, Resick, Rosner & Steil, 2013).
Additionally, we will assess moderators of treatment response, epigenetic profiles, direct and indirect costs of the disorder and neurophysiological processing of threat cues in PTSD and their respective changes in the course of these two treatments (D-CPT and TAU). Results will provide data on treatment efficacy, as well as exploring associations to epigenetic profiles and the neurobiological processing of threat cues.

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Organizational Data

  •   DRKS00004787
  •   2013/03/18
  •   [---]*
  •   yes
  •   Approved
  •   D-CPT, Ethikkommission der Philosophisch-Pädagogischen Fakultät der Katholischen Universität Eichstätt-lngolstadt
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   DSM-IV: 309.81 - Posttraumatic Stress Disorder
  •   F43.1 -  Post-traumatic stress disorder
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Interventions/Observational Groups

  •   D-CPT-arm: Psychotherapeutic intervention with 30 to 36 sessions (50 min each) within 16 to 20 weeks. The treatment is a developmentally adapted Cognitive Processing Therapy (D-CPT). It is organized in four phases: committment, emotion regulation training, intensive trauma-focuesd treatment and developmental tasks training.
  •   TAU-arm (Treatment As Usual): Patients allocated to TAU will be either encouraged to continue their current treatment or will be referred to institutions of public mental healthcare. If TAU-patients are dissatisfied with their treatment after 7 months, they will be offered D-CPT.
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Characteristics

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

Severity of PTSD
Measure: German version of the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA, in German IBS-P-KJ; Steil & Füchsel, 2006)
Measurement points: Pretest (before starting the treatment), Posttest (after ending the treatment, approx. 16 weeks), Follow-Up I (3 months after ending the treatment), Follow-Up II (6 months after ending the treatment; for patients of the TAU-arm only those, who didn’t choose D-CPT after Follow-Up I)

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Secondary Outcome

Each at Pretest (before starting the treatment), Posttest (after ending the treatment, approx. 16 weeks), Follow-Up I (3 months after ending the treatment), Follow-Up II (6 months after ending the treatment; for patients of the TAU-arm only those, who didn’t choose D-CPT after Follow-Up I):
1.Self-rating of PTSD symptoms : German version of the UCLA PTSD INDEX for DSM IV (Arbeitsgruppe Psychotraumatologie KJP Ulm, 2008), German version of the Trauma Symptom Checklist for Children (Matulis & Steil, 2010)
2.Axis I and II comorbidity: German version of the Structured Clinical Interview for DSM Disorders (SKID; Wittchen, Zaudig & Fydrich, 1997), further important parts of the Diagnostic Interview for Mental Disorders in Childhood and Adolescence (Kinder-DIPS; Schneider, Unnewehr & Margraf, 2009), nicotine section of the Expert System for Diagnosing Mental Disorders (DIA-X, Wittchen & Pfister, 1997)
3.Depressive symptoms: German version of the Beck Depression Inventory (BDI-II; Hautzinger, Keller & Kühner, 2006)
4.Dissociative symptoms: German version of the adolescent Dissociative Experiences Scale (HDI; Brunner, Resch, Parzer & Koch, 2008)
5.Symptoms of emotional disregulation: German version of the Borderline Symptom Checklist 23 (BSL-23; Bohus, Kleindienst, Limberger, Stieglitz, Domsalla, Chapman et al., 2009)
6.General pathology and impairment: German version of the Youth-Self-Report (YSR; Döpfner, 1998)
7.Service use and quality of life: Client Sociodemographic and Service Receipt Inventory (CSSRI; Chisholm et al., 2000), EuroQol 5 Dimensions (EQ-5D; Dolan, 1997)


Each at Pretest (before starting the treatment) and Follow-Up I (3 months after ending the treatment):
1.Assessment of psychophysiological parameters by Electroencephalogram (EEG)
2.Epigenetic micro-array analyses of DNA saliva samples

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2013/07/09
  •   90
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   21   Years
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Additional Inclusion Criteria

Sexual or physical abuse after the age of three (definition according to the American Psychological Association Committee on Professional Practice and Standards, 1999)
PTSD (according to CAPS-CA: meeting 1 B-criterion, 2 C-criteria, 2 D-criteria) persisting for longer than one month
PTSD as primary diagnosis
Living in safe conditions
Sufficient knowledge of German language
Informed consent from parents/legal guardians (if under 18) and participant
Stable psychopharmacological medication at study entry (in the last 3 weeks there was either no or a constant psychopharmacological medication)

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Exclusion Criteria

Acute suicidality within the last 6 months
Life threatening self-harming behavior within the last 6 months
Substance related or organic mental disorder
Pervasive developmental disorder
Current or lifetime diagnosis of a psychotic disorder according to DSM-IV
Current or lifetime diagnosis of a bipolar disorder according to DSM-IV
Current diagnosis of substance dependence according to DSM-IV (abstinence < 6 months)
Mental retardation (IQ ≤ 75)
Simultaneous psychotherapeutic treatment

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Addresses

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    • Katholische Universität Eichstätt-Ingolstadt; Lehrstuhl Klinische und Biologische Psychologie
    • Ms.  Prof. Dr. Dipl.-Psych.  Rita  Rosner 
    • Ostenstr. 25
    • 85072  Eichstätt
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf; Institut für Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Prof. Dr. med.  Hans-Helmut  König 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universität Bielefeld; Arbeitseinheit für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr. Dipl.-Psych.  Frank  Neuner 
    • Universitätsstraße 25
    • 33615  Bielefeld
    • Germany
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    • Max-Planck-Institut für Psychiatrie
    • Ms.  Dr. med.  Ulrike  Schmidt 
    • Kraepelinstr. 2-10
    • 80804 
    • Germany
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    • Goethe-Universität Frankfurt am Main; Klinische Psychologie & Psychotherapie
    • Ms.  Dr. Dipl.-Psych.  Regina  Steil 
    • Varrentrappstr. 40-42
    • 60486  Frankfurt am Main
    • Germany
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    • Freie Universität Berlin; Arbeitsbereich Klinische Psychologie und Psychotherapie
    • Ms.  Univ.-Prof. Dr. Dipl.-Psych.  Babette  Renneberg 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Katholische Universität Eichstätt-Ingolstadt; Lehrstuhl Klinische und Biologische Psychologie
    • Ms.  Prof. Dr. Dipl.-Psych.  Rita  Rosner 
    • Ostenstr. 25
    • 85072  Eichstätt
    • Germany
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    • Katholische Universität Eichstätt-Ingolstadt; Lehrstuhl Klinische und Biologische Psychologie
    • Ms.  Dipl.-Psych.  Eline  Rimane 
    • Levelingstr. 7
    • 85049  Ingolstadt
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF) Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/08/31
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Trial Publications, Results and other Documents

  •   Rosner, R., König, H.-H., Neuner, F., Schmidt, U., & Steil, R. (2014). Developmentally adapted cognitive processing therapy for adolescents and young adults with PTSD symptoms after physical and sexual abuse: study protocol for a randomized controlled trial. Trials, 15. doi: 10.1186/1745-6215-15-195.
  •   Rosner, R., Rimane, E., Frick, U., Gutermann, J., Hagl, M., Renneberg, B., . . . Steil, R. (2019). Effect of Developmentally Adapted Cognitive Processing Therapy for Youth With Symptoms of Posttraumatic Stress Disorder After Childhood Sexual and Physical Abuse: A Randomized Clinical Trial. JAMA Psychiatry. Advance online publication. https://doi.org/10.1001/jamapsychiatry.2018.4349
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* This entry means the parameter is not applicable or has not been set.