Trial record 1 of 28 for:
Open Studies | "Panic Disorder"
Mechanisms of Panic Disorders Treatment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Medicine Greifswald.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Medicine Greifswald
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01323556
First received: March 3, 2011
Last updated: April 8, 2011
Last verified: March 2011
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Purpose
Investigation of mechanisms of exposure based learning by
- Investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure
- Disentangling the effects of interoceptive exposure exercises in panic disorder
| Condition | Intervention | Phase |
|---|---|---|
|
Panic Disorder Agoraphobia Panic Attacks |
Behavioral: Cognitive Behavioural Therapy (CBT) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure |
Resource links provided by NLM:
Further study details as provided by University Medicine Greifswald:
Primary Outcome Measures:
- Hamilton Anxiety Rating Scale (HARS) [ Time Frame: up to 32 weeks (follow up) ] [ Designated as safety issue: No ]structured clinician rating assessing the severity of an anxiety disorder
- Clinician Global Impression Scale (CGI) [ Time Frame: up to 32 weeks (follow up) ] [ Designated as safety issue: No ]clinician rating assessing the severity of panic disorder and agoraphobia
- Panic and Agoraphobia Scale (PAS) [ Time Frame: up to 32 weeks (follow up) ] [ Designated as safety issue: No ]PAS is self-rating assessing panic disorder and agoraphobia severity with five factor analytic derived subscale scores (panic attacks, anticipatory anxiety, agoraphobic avoidance, health concerns, functional impairment) and a total score indicating the global severity. The questionnaire was specifically developed for monitoring changes during psychotherapy or psychopharmacological treatments.
- Mobility Inventory [ Time Frame: up to 32 weeks (follow up) ] [ Designated as safety issue: No ]Self-rating assessing the extent of situational avoidance. The questionnaire comprises 27 situations that have to be evaluated in regard to frequency of avoidance, when alone or when accompanied.
- Number of panic attacks [ Time Frame: up to 32 weeks (follow up) ] [ Designated as safety issue: No ]Number of panic attacks experienced during the last week is assessed.
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exposure with fear augmentation
exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation)
|
Behavioral: Cognitive Behavioural Therapy (CBT)
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure
|
|
Experimental: Exposure without fear augmentation
exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure
|
Behavioral: Cognitive Behavioural Therapy (CBT)
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies
|
Detailed Description:
The study aims on investigating the effect of fear augmentation during in-vivo exposure by adding interoceptive exposure (e.g., hyperventilation) in PD/AG patients. By comparing the fear augmentation group with the therapist-guided CBT exposure, and by measuring autonomic arousal during and between exposure sessions, it will be possible to study the mechanisms of exposure based learning. A second aim is to disentangle effects of specific interoceptive exposure exercises (e.g., respiratory vs. vestibular stimulation). Finally, by including patients without agoraphobic avoidance it will be possible to investigate whether interoceptive exposure alone will have any effect. This might open the door for early interventions for individuals after experiencing an initial panic attack to prevent the development of a severe panic disorder with agoraphobic avoidance.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-65 years old
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of panic disorder, panic disorder with agoraphobia OR initial panic attacks
- CGI ≥ 4 (except persons with initial panic attacks)
- Informed Consent
Exclusion Criteria:
- Acute suicidality
- Current substance use disorder
- Lifetime diagnosis of psychotic disorders, bipolar disorders, borderline personality disorders
- Severe medical condition (chronic conditions)
- Current psychotherapeutic or psychopharmacological treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323556
Contacts
| Contact: Alfons O Hamm, PhD | +49 (0)3834-863716 | hamm@uni-greifswald.de |
Locations
| Germany | |
| Prof. Dr. Alfons Hamm | Recruiting |
| Greifswald, Germany, 17489 | |
| Contact: Alfons O. Hamm, Prof. Dr. +49 (0)3834-863716 hamm@uni-greifswald.de | |
Sponsors and Collaborators
University Medicine Greifswald
German Federal Ministry of Education and Research
Investigators
| Principal Investigator: | Alfons O. Hamm, Prof. Dr. | Institute for Psychology Ernst-Moritz-Arndt-University Greifswald Franz-Mehring-Str. 47; 17487 Greifswald, Germany |
| Study Director: | Thomas Lang, Dr. | Center for Clinical Psychology and Rehabilitation/ Christoph-Dornier-Foundation for Clinical Psychology University Bremen Grazer Str. 2b 28359 Bremen, Germany |
| Study Chair: | Alexander L. Gerlach, Prof. Dr. | Institute for Clinical Psychology and Psychotherapy WWU Münster Fliednerstr. 21 48149 Münster, Germany |
| Study Chair: | Tilo Kirchner, Prof. Dr. | Department of Psychiatry und Psychotherapy Philipps-University Marburg Rudolf-Bultmann- Straße 8 35039 Marburg, Germany |
| Study Chair: | Georg W. Alpers, Prof. Dr. | Institute for Biological Psychology, Clinical Psychology and Psychotherapy University Würzburg Marcusstrasse 9-11 97070 Würzburg, Germany |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Dr. A. Hamm, University of Greifswald, Department of Clinical Psychology |
| ClinicalTrials.gov Identifier: | NCT01323556 History of Changes |
| Other Study ID Numbers: | AH 11.2009 |
| Study First Received: | March 3, 2011 |
| Last Updated: | April 8, 2011 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
Keywords provided by University Medicine Greifswald:
|
Panic disorder agoraphobia panic attacks exposure based learning |
interoceptive exposure exercises fear augmentation in vivo exposure |
Additional relevant MeSH terms:
|
Agoraphobia Panic Disorder Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013