Trial document




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  DRKS00021142

Trial Description

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Title

Trauma-focused psychodynamic therapy and STAIR Narrative Therapy of post-traumatic stress disorder related to childhood maltreatment: a multicenter randomized clinical trial examining psychological, biological and health economic outcomes

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Trial Acronym

ENHANCE

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URL of the Trial

https://www.gesundheitsforschung-bmbf.de/de/enhance-posttraumatische-belastungsstorung-bei-erwachsenen-verbunden-mit-gewalt-und-8889.php

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Brief Summary in Lay Language

The purpose of this trial is (1) to enhance the efficacy of trauma-focused STAIR Narrative Therapy (SNT) and trauma-focused psychodynamic therapy (TF-PDT) in post-traumatic stress disorder related to childhood maltreatment (PTSD-CM), (2) to compare the efficacy of TF-PDT and SNT with a minimal attention waiting list (MA-WL) condition, (3) to compare the efficacy of SNT and TF-PDT, to (4) study the cost-effectiveness of SNT and TF-PDT and (5) to improve the psychological and biological understanding of PTSD-CM.

The study (A-1) is designed as a multi-center randomized clinical trial of four years duration including 10 outpatient university treatment centers in five cities in Germany, with one institution in each center providing SNT and another TF-PDT.

Adults with PTSD-CM will be randomly assigned to one of the three study conditions. Both SNT and TF-PDT are manual-guided and will encompass up to 24 sessions each. Subjects on the MA-WL will wait for 24 weeks, after that they may choose either SNT or TF-PDT. Primary outcome will be the severity of PTSD. Secondary outcomes include response and remission rates, dissociation, depression, mentalization, personality functioning, and attachment. Outcomes will be assessed after 10 sessions, at the end of therapy/waiting period, and 6 and 12 months after the end of therapy. In addition, four interrelated add-on projects (B-1, B-2, B-3, B-4) including sub-samples of the treatment study A-1 will examine (a) treatment integrity (adherence and competence) and moderators and mediators of outcome (B-1), (b) biological parameters (B-2, e.g. DNA damage, Brain Derived Neurotrophic Factor (BDNF) protein level and epigenetics, reactive oxygen species, telomere shortening), (c) structural and functional neural changes by neuroimaging (B-3) and (d) cost-effectiveness of the treatments (B-4, costs and utilities).

Participants will be adult subjects of all sexes with PTSD related to CM by a caretaker or person in authority over them before the age of 18 years, age: 18 to 65 years; continuing stable medication is permitted. The following conditions will be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions, concurrent psychotherapy.

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Brief Summary in Scientific Language

Psychotherapy is the treatment of choice for post-traumatic stress disorder related to childhood maltreatment (PTSD-CM). STAIR Narrative Therapy (SNT) proved to be efficacious in PTSD-CM in two randomized controlled trials. However, less than 30% of patients achieved full remission and less than half of the patients achieved good end-state functioning (46%). Furthermore, the psychology and biology of PTSD-CM have not yet been fully understood. Thus, there is a need to further improve the treatment and understanding of PTSD-CM.

The purpose of the planned study is to enhance the efficacy of STAIR Narrative Therapy (SNT) and trauma-focused psychodynamic therapy (TF-PDT) in PTSD-CM by tailoring the treatments more specifically to the patients as described in refined treatment manuals. In addition, the trial aims at improving the psychological and biological understanding of PTSD-CM and at examining the cost-effectiveness of the treatments.

The treatment study (A-1) is designed as a multi-center randomized clinical trial of four years duration including 5 outpatient university treatment centers in Germany, with one institution in each center providing SNT and another TF-PDT. Data management, randomization and monitoring will be carried out by an independent ECRIN certified data coordinating center (DCC Marburg).

Participants will be adult subjects of all sexes with PTSD related to CM by a caretaker or person in authority over them before the age of 18 years, age: 18 to 65 years; continuing stable medication is permitted. The following conditions will be excluded: psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions, concurrent psychotherapy.

Adults with PTSD-CM will be evaluator to monitor their status. Outcomes will be assessed after 10 sessions, at the end of therapy/waiting period, and 6 and 12 months after end of therapy. Both SNT and TF-PDT are expected to be superior to MA-WL in the primary outcome. For SNT and TF-PDT both noninferiority of TF-PDT and superiority of each of the active treatments over the other will be tested. A difference of 8 points in CAPS-5-total regarded as clinically not important (Schnurr et al., 2003; Stefanovics et al., 2018, Norman et al., 2003) will be used as a noninferiority margin.

In addition, four interrelated add-on projects (B-1, B-2, B-3, B-4) including sub-samples of the treatment study A-1 will examine (a) treatment integrity (adherence and competence) by blinded ratings of audio-taped therapy sessions as well as moderators and mediators of treatment outcome (B-1), (b) biological parameters (B-2, e.g. DNA damage, reactive oxygen species, telomere shortening), (c) structural and functional neural changes by neuroimaging (B-3) and (d) cost-effectiveness of the treatments (B-4, costs and utilities).

The study is part of the ENHANCE consortium funded by the Federal Ministry of Education and Research – 01KR1801A. Coordinator of the consortium and PI of the treatment study A-1: Prof. Dr. Falk Leichsenring, University of Giessen, Clinic of Psychosomatics and Psychotherapy), Co-PI: Prof. Jürgen Hoyer, Institute of Clinical Psychology and Psychotherapy, Technische Universitaet Dresden.


References

Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care, 41(5), 582-592.
Schnurr, P. P., Friedman, M. J., Engel, C. C., Foa, E. B., Shea, M. T., Chow, B. K., Resick, P. A., Thurston, V., Orsillo, S. M., Haug, R., Turner, C. & Bernardy, N. (2007). Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA 297, 820-30.
Stefanovics, E. A., Rosenheck, R. A., Jones, K. M., Huang, G. & Krystal, J. H. (2018). Minimal Clinically Important Differences (MCID) in Assessing Outcomes of Post-Traumatic Stress Disorder. Psychiatric Quarterly 89, 141-155.



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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

  •   DRKS00021142
  •   2020/03/24
  •   [---]*
  •   yes
  •   Approved
  •   AZ 168/19, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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

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

  •   STAIR Narrative Therapy
  •   Trauma-Focused Psychodynamic Therapy (TF-PDT)
  •   Minimal Attention Waiting List (MA-WL)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Treatment
  •   Parallel
  •   0
  •   N/A
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Primary Outcome

CAPS-5 total score (post, 6 and 12 months after treatment termination)

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Secondary Outcome

remission (CAPS-Total <20), response (50%-reduction of CAPS-total-score), complex PTSD (International Trauma Questionnaire), dissociative symptoms (Dissociative Experience Scale) depression (Beck Depression Inventory II), Clinical Global Impression rating for improvement (CGI-I), mentalization (Mentalization Questionnaire), attachment (Experiences in Close Relationships-Revised), personality organization (Borderline Personality Inventory), and number of treatment drop-outs

Assessements post, 6 and 12 months after treatment termination

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Planned
  •   2020/05/01
  •   328
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Persons of all sexes with PTSD related to CM by a caretaker or person in authority over them before the age of 18 years, age: 18 to 65 years; continuing stable medication been ongoing for at least 3 months prior to study entry is permitted.

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Exclusion Criteria

psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions, concurrent psychotherapy.

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Addresses

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    • Abt. Psychosomatik und Psychotherapie, Universität Gießen
    • Mr.  Prof. Dr.  Falk  Leichsenring 
    • Ludwigstr. 76
    • 35391  Gießen
    • Germany
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    • Abt. Psychosomatik und Psychotherapie, Universität Gießen
    • Mr.  Prof. Dr.  Falk  Leichsenring 
    • Ludwigstr. 76
    • 35391  Gießen
    • Germany
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    • Klinik für Psychsomatik und Psychotherapie der Universität Giessen
    • Ms.  MSc  Fatima  Nöske 
    • Ludwigstr. 76
    • 35391  Giessen
    • Germany
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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 planned
  •   [---]*
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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.