Trial document




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  DRKS00008743

Trial Description

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Title

Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction Learning

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Trial Acronym

PROTECT-AD

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URL of the Trial

http://www.protect-ad.de

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Brief Summary in Lay Language

PROTECT-AD is a cognitive behavioral treatment study involving highly qualified psychotherapeutic centers at seven German universities.
It is our goal to further investigate and optimize existing effective treatments of anxiety disorders. In order to achieve this, we want to investigate the effect of extinction learning in an “intensified” psychological intervention on treatment outcome in adults and children with anxiety disorders.
The intensified psychological intervention is characterized by a higher number of exposure trials over a short time period. In the control condition the exposure trials take place in a weekly interval, analog to standard care.

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Brief Summary in Scientific Language

Novel preclinical research evidence suggests extinction learning as the core mechanism of action of exposure-based therapies and provides according strategies to improve the effectiveness of treatment by optimized extinction. A translational research agenda is suggested to examine whether enhanced extinction learning components derived from preclinical research, applied within an “intensified” exposure-based treatment, improves outcomes. In a multicentre randomised clinical trial, linked to mechanistic subprojects, we test in n=620 patients with primary AD allowing for comorbidity whether intensified psychological interventions based on augmented extinction learning (IPI) result in faster, stronger and more persistent outcomes on subjective, clinical, behavioural, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). We hypothesize that (a) enhanced extinction elements (IPI) will result in higher effect sizes, faster recovery, (b) more pronounced changes in an array of systems, including elements of extinction learning and in objective behavioural measures assessed in intersession exposure trials. We also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.

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Organizational Data

  •   DRKS00008743
  •   2015/06/18
  •   2015/11/13
  •   yes
  •   Approved
  •   EK 234062014, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  •   NCT02605668  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   F40.1 -  Social phobias
  •   F40.2 -  Specific (isolated) phobias
  •   F40.00 -  [generalization F40.0: Agoraphobia]
  •   F40.01 -  [generalization F40.0: Agoraphobia]
  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
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Interventions/Observational Groups

  •   Intensified psychological intervention, based on optimized extinction learning (IPI)
    12 sessions a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6)
  •   Standard intervention without optimized extinction learning (TAU)
    12 sessions a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10)
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Characteristics

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

Stronger reduction of anxiety symptoms in the IPI group than in the TAU group, Anxiety symptoms are assessed using the HAM-A at Baseline, Post/after session twelve and Follow up/after six months

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Secondary Outcome

CGI (symptom severity),
CIDI (DIA-X) (categorical diagnosis),
DSM-5 Cross-D (anxiety),
BSI (SCL-90) (psychopathol. symptoms),
BDI-II (depressive symptoms),
ASI (anxiety sensitivity),
PAS (panic/agoraphobia),
ACQ (cognition in agoraphobia)
BSQ (bodily anxiety/cognition/avoidance)
MI (agoraphobic avoidance),
GAD-7 (worrying),
LSAS (social anxiety),
DSM-5 Specific Phobia Scale
WHODAS 2.0 (disability),
EQ5D (quality of life),
All measurements are taken three times (Baseline, Post/after session twelve, Follow up/after six months), the BSI additionally during course of treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • University Medical Center 
  • other 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/12/03
  •   620
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   15   Years
  •   70   Years
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Additional Inclusion Criteria

• age 15 – 70 years
• on or more of the following DSM-V Anxiety Disorders: Panic disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
• HAMA – Score ≥ 18
• CGI – Score ≥ 3
• Can attend Therapie regularly (with or without suppot)
• Informed Consent

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Exclusion Criteria

• Every reason the protocol may not be upheld (e.g. planned hospitalization within study time frame, planning to move away, etc.)
• Current Suicidal tendency
• DSM-V Bipolar Disorder
• DSM-V Psychotic Disorder
• DSM-V Borderline PD
• Current treatment of other Mental Disorder (Drugs, Psychotherapy)
• Current Alcohol, Benzodiazepine or other Substance Use Disorders
• Severe medical illness/condition (every serious physical illness, including cardiovascular, kidney, endocrinological and neurological conditions, Hepatitis or other clinical findings that suggest a severe illness and may affect participation in the study)

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Addresses

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    • Technische Universität Dresden,Institut für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Hans-Ulrich  Wittchen 
    • Chemnitzer Straße 46
    • 01187  Dresden
    • Germany
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    • Ruhr-Universität Bochum, Klinische Kinder- und Jugendpsychologie
    • Universitätsstraße 150
    • 44780  Bochum
    • Germany
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    • Ernst- Moritz- Arndt- Universität, Lehrstuhl für Physiologische und Klinische Psychologie/Psychotherapie
    • Franz-Mehring-Str. 47
    • 17487  Greifswald
    • Germany
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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Universität Würzburg, Institut für Psychologie
    • Marcusstr. 9-11
    • 97070  Würzburg
    • Germany
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    • Philipps-Universität Marburg, Klinik für Psychiatrie und Psychotherapie
    • Rudolf-Bultmann-Straße 9
    • 35033  Marburg
    • Germany
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    • Uniklinikum Würzburg, Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie
    • Füchsleinstraße 15
    • 97080  Würzburg
    • Germany
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    • Westfälische Wilhelms-Universität Münster, Klinik für Psychiatrie und Psychotherapie
    • Albert-Schweitzer-Campus 1 Gebäude A9
    • 48149  Münster
    • Germany
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    • Technische Universität Dresden, Institut für Klinische Psychologie und Psychotherapie
    • Mr.  Prof. Dr.  Hans-Ulrich  Wittchen 
    • Chemnitzer Straße 46
    • 01187  Dresden
    • Germany
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    • Technische Universität Dresden, Institut für Klinische Psychologie und Psychotherapie
    • Mr.  Dipl.-Psych.  Ingmar  Heinig 
    • Chemnitzer Straße 46
    • 01187  Dresden
    • Germany
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Sources of Monetary or Material Support

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

  •   Recruiting complete, follow-up complete
  •   2019/07/24
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Trial Publications, Results and other Documents

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