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Providing Tools for Effective Care and Treatment of Anxiety Disorders (PROTECT-AD)

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ClinicalTrials.gov Identifier: NCT02605668
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : August 3, 2016
Sponsor:
Collaborators:
Ruhr University of Bochum
University Medicine Greifswald
Charite University, Berlin, Germany
University of Wuerzburg
Philipps University Marburg Medical Center
Wuerzburg University Hospital
Westfälische Wilhelms-Universität Münster
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:

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, the investigators 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.


Condition or disease Intervention/treatment Phase
Panic Disorder Agoraphobia Specific Phobias Social Anxiety Disorder Behavioral: Intensified psychological intervention Behavioral: Standard intervention Not Applicable

Detailed Description:
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 multicenter randomized clinical trial, linked to mechanistic subprojects, the investigators 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, behavioral, physiological and neural indices as compared to an, otherwise identical, standard research treatment without explicit enhanced extinction (TAU). The investigators 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 behavioral measures assessed in intersession exposure trials. The investigators also examine moderators of outcome (i.e. type of diagnosis, comorbidity) and explore whether IPI is associated with lower health care costs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Providing Tools for Effective Care and Treatment of Anxiety Disorders (AD): Outcomes, Mediators and Moderators of Enhanced Extinction
Study Start Date : January 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Intensified Psychological Intervention
Intensified psychological intervention (Cognitive Behavioral Therapy), based on optimized extinction learning
Behavioral: Intensified psychological intervention
12 sessions of Cognitive Behavioral Therapy 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)

Active Comparator: Treatment As Usual
Standard intervention (Cognitive Behavioral Therapy) without optimized extinction learning
Behavioral: Standard intervention
12 sessions of Cognitive Behavioral Therapy 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)




Primary Outcome Measures :
  1. change in somatic and psychic anxiety symptoms [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow up (6 months after end of therapy) ]
    Anxiety symptoms are assessed using the clinician-rated Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A for the HAMA). Stronger, faster and more persistent reduction of anxiety symptoms in the IPI group than in the TAU group is expected.


Secondary Outcome Measures :
  1. change in severity of the anxiety disorder [ Time Frame: assessed five times: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    Severity of the anxiety disorder is assessed by the clinician-rated Clinical Global Impression Scale (CGI). It is anchored for anxiety disorders.

  2. change in categorial diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV/5) [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    categorical diagnoses are assessed using a German version of the Composite International Diagnostic Interview (CIDI).

  3. change in screened anxiety symptoms [ Time Frame: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    The DSM-5 cross-cutting symptom measure for anxiety disorders ("Cross-D") is used as a brief screener for anxiety symptoms.

  4. change in depressive symptoms [ Time Frame: assessed fivetimes: Baseline, therapy session 4 (week 2 of therapy), therapy session 11 (week 5 to week 9 of therapy), Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    depressive symptoms are assessed using the Beck Depression Inventory (BDI-II)

  5. change in anxiety sensitivity [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    anxiety sensitivity is assessed using the Anxiety sensitivity inventory (ASI)

  6. change in panic and agoraphobic symptoms [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    panic and agoraphobic symptoms are assessed using the Panic and agoraphobia scale (PAS)

  7. change in agoraphobic avoidance [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    agoraphobic avoidance is assessed using the Mobility Inventory (MI)

  8. change in symptoms of Generalized Anxiety Disorder [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    symptoms of generalized anxiety disorder (GAD)are assessed using the GAD-7

  9. change in social anxiety [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    social anxiety is assessed using the Liebowitz Social Anxiety Scale (LSAS)

  10. change in Specific Phobia symptoms [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    symptoms of specific phobia are assessed using an adapted version of the DSM-5 dimensional scale for specific phobias

  11. change in disability [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    Disability is assessed using the 12-item version of the World Health Organization Disability Schedule (WHODAS 2.0)

  12. change in quality of life [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    Quality of life is assessed using the EuroQol five-dimensional measure for quality of life (EQ5D)

  13. change in psychopathological symptoms [ Time Frame: assessed seven times: Baseline, therapy sessions 2 (week 1 of therapy), 4 (week 2), 7 (week 3 to 5), 10 (week 4 to 8), 11 (week 5 to 9), 12 (week 6 to 10) Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    psychopathological symptoms are assessed using the Brief Symptom Inventory (BSI), a short form of the Symptom Checklist 90 (SCL-90). At Baseline, Post and Follow Up, the 53 item Version is used, during therapy the 18 item version is used

  14. change in agoraphobic cognitions [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    agoraphobic cognitions are assessed using the Agoraphobic Cognitions Questionnaire (ACQ)

  15. fear of body sensations [ Time Frame: assessed three times: Baseline, Post (1 week after end of therapy) and Follow Up (6 months after end of therapy) ]
    fear of body sensations is assessed using the Body Sensations Questionnaire (BSQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 15 - 70 years
  • one or more of the following DSM-IV/5 anxiety disorders: Panic Disorder, Agoraphobia, Social Anxiety Disorder, Specific Phobia
  • HAMA - Score > 18
  • CGI - Score > 3
  • Can attend therapy regularly (with or without support)
  • Informed Consent

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-5 Bipolar Disorder
  • DSM-5 Psychotic Disorder
  • DSM-5 Borderline Personality Disorder
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605668


Contacts
Contact: Hans-Ulrich Wittchen, Ph.D. +49-(0)351-463-36983 hans-ulrich.wittchen@tu-dresden.de
Contact: Ingmar Heinig +49-(0)351-463-36889 ingmar.heinig@tu-dresden.de

Locations
Germany
Technische Universität Dresden, Institute of Clinical Psychology and Psychotherapy Recruiting
Dresden, Sachsen, Germany, 01187
Contact: Ingmar Heinig, Dipl.-Psych.    +49 351 463 36889    ingmar.heinig@tu-dresden.de   
Contact: Sebastian Höll    +49 351 463 36983    hans-ulrich.wittchen@tu-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
Ruhr University of Bochum
University Medicine Greifswald
Charite University, Berlin, Germany
University of Wuerzburg
Philipps University Marburg Medical Center
Wuerzburg University Hospital
Westfälische Wilhelms-Universität Münster
Investigators
Principal Investigator: Hans-Ulrich Wittchen, Ph.D. Technische Universität Dresden

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02605668     History of Changes
Other Study ID Numbers: 01EE1402A
DRKS00008743 ( Registry Identifier: German Clinical Trials Register )
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Technische Universität Dresden:
Anxiety Disorders
Extinction Learning
Optimized Extinction
Behavioral Therapy
Massed Confrontation
Social Anxiety Disorder
Specific Phobia
Panic Disorder
Agoraphobia

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Phobic Disorders