Trial document




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  DRKS00004288

Trial Description

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Title

Cognitive-behavioral treatment for female patients with PTSD and SUD

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Trial Acronym

CANSAS 2.A

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Many people with a substance use disorder suffer from the consequences of traumatic experiences such as sexual or physical abuse in different phases of their lives. According to international guidelines the treatment of these patients requires an integrative therapy, which is tailored to their complex needs. Such specific programs, that pursue an integrative therapy of addiction and the consequences of trauma, have proved of value in the US. However, respective offers have to date not been commonly available in Germany. In particular, there are no tested interventions existent, which are adapted to the demands outpatient addiction treatment. The study therefore aims at testing the effectiveness of the “Seeking Safety” therapy program (Najavits 2002, 2008), a specific treatment for addict patients with posttraumatic disorders (PTSD). Female patients with PTSD and substance-dependence will be included in the study. The central questions are whether this specific treatment in the sense of its objective leads to improved posttraumatic stress symptoms as well as reduced substance use, and how its effectiveness is to be assessed compared to other interventions.

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Brief Summary in Scientific Language

PTSD is a frequent comorbidity among individuals with childhood abuse and SUD. In German samples of patients with SUD, the prevalence of current PTSD, which is in most cases related to childhood abuse, is 15-30%, (Schäfer et al. 2007, Driessen et al. 2008). Higher rates of PTSD are found in female patients as compared to males (25%-50%). According to international guidelines, integrated treatment is necessary to meet the complex needs of these patients. In Europe, no evaluated treatments for individuals with PTSD and SUD are available yet, representing a substantial gap in the provision of services for victims of CAN. “Seeking Safety“ (Najavits 2002), a manualised, cognitive-behavioural treatment, has been shown to be effective in several studies in the United States. The manual has been published in German (www.trauma-und-sucht.de). A pilot trial showed good feasibility and acceptance, and a high retention rate (85%) in N=38 female victims of childhood abuse with PTSD and SUD (Schäfer et al. 2010b). As a basis for the dissemination of the program, however, its efficacy needs to be replicated under the conditions of the German health care system. The aim of the study is to test the efficacy of a standardised cognitive-behavioural group therapy (“Seeking Safety”) in female adults with SUD and PTSD in a randomized-controlled trail. In international studies, the program has consistently proven superior efficacy compared to the treatment usually offered by substance abuse services (TAU), and non-inferiority compared to other standard CBT-interventions. Standardised CBT interventions are not commonly applied in German SUD outpatient services. Nevertheless, the program will be tested against a standardised relapse prevention training (S.T.A.R.; Körkel & Schindler 2003).

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Organizational Data

  •   DRKS00004288
  •   2012/09/18
  •   [---]*
  •   yes
  •   Approved
  •   PV4177, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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

  •   F43.1 -  Post-traumatic stress disorder
  •   substance abuse
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Interventions/Observational Groups

  •   "Seeking safety"-branch: psychological intervention programm comprising 14 group sessions (90 minutes each) for approx. 8 participants and an additional individual introduction and closing sessions
  •   S.T.A.R.-branch: structured relapse prevention programm comprising 14 weekly group sessions (90 minues each) with approx. 8 participants and an additional individual introduction and closing session
  •   Treatment as usual-branch: comprised any treatment which is normally offered to individuals with substance use disorders (e.g. individual and group psychotherapy, rehabilitation, self-help groups etc.)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

PTSD symptoms
Method: interview: SCID-I, PSS-I, self-report questionnaire: PDS,
time points: T0: before therapy, T1: after therapy (16 weeks later), T2: 3 months after the end of therapy, T3: 6 months after the end of theray

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Secondary Outcome

substance use
mehtod: interview: ASI-Lite, SCID-I),
emotion regulation
method: self-report questionnaire: H-FERST, DERS
time points: T0: before therapy, T1: after therapy (16 weeks later), T2: 3 months after the end of therapy, T3: 6 months after the end of theray

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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 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/10/01
  •   342
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

diagnosis of substance abuse disorder (according to DSM-IV),
at least partial PTSD (according to DSM-IV),
sufficient knowledge of the German language

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Exclusion Criteria

intravenous drug use, acute psychosis, organic mental disorder, severe cognitive impairment, suicidal tendency, characteristics interfereing with therapy (e.g. impending incarceration, life-threatening, instable medical illness)

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  PD Dr.  Ingo  Schäfer 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    start of 1:1-Block address contact primary-sponsor
    •   040-7410 59290
    •   040-7410-55545
    •   ischaefer at uke.de
    •   [---]*
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    • Klinik für Psychiatrie und Psychotherapie, Bethel Ev. Krankenhaus
    • Mr.  Prof. Dr.  Martin  Driessen 
    • Remterweg 69/71
    • 33617  Bielefeld
    • Germany
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    • LVR-Klinikum Essen Kliniken/Institut der Universität Duisburg-Essen Klinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr.  Norbert  Scherbaum 
    • Altendorfer Strasse 97-101
    • 45143  Essen
    • Germany
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    • LVR-Klinikum Köln Klinik für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Barbara  Schneider 
    • Wilhelm-Griesinger-Str. 23
    • 51109  Köln
    • Germany
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    end of 1:1-Block address contact other
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    • Medizinische Hochschule HannoverKlinik für Psychiatrie, Sozialpsychiatrie und Psychotherapie
    • Mr.  Prof. Dr.  Thomas  Hillemacher 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Kklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  PD Dr.  Ingo  Schäfer 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
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    •   040-7410 59290
    •   040-7410-55545
    •   ischaefer at uke.de
    •   [---]*
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    • Kklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  PD Dr.  Ingo  Schäfer 
    • Martinistrasse 52
    • 20246  Hamburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   040-7410 59290
    •   040-7410-55545
    •   ischaefer at uke.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/20
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Trial Publications, Results and other Documents

  •   Schäfer I, Lotzin A, Hiller P, Sehner S, Driessen M, Hillemacher T, Schäfer M, Scherbaum N, Schneider B & Grundmann J (2019) A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders. European Journal of Psychotraumatology; 10:1577092
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* This entry means the parameter is not applicable or has not been set.