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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01323556
Other study ID # AH 11.2009
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received March 3, 2011
Last updated April 8, 2011
Start date March 2010
Est. completion date May 2012

Study information

Verified date March 2011
Source University Medicine Greifswald
Contact Alfons O Hamm, PhD
Phone +49 (0)3834-863716
Email hamm@uni-greifswald.de
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial Summary

Investigation of mechanisms of exposure based learning by

1. Investigating the effects of fear augmentation by interoceptive exposure during in vivo exposure

2. Disentangling the effects of interoceptive exposure exercises in panic disorder


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date May 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
Cognitive Behavioural Therapy (CBT)
12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies

Locations

Country Name City State
Germany Prof. Dr. Alfons Hamm Greifswald

Sponsors (2)

Lead Sponsor Collaborator
University Medicine Greifswald German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Anxiety Rating Scale (HARS) structured clinician rating assessing the severity of an anxiety disorder up to 32 weeks (follow up) No
Primary Clinician Global Impression Scale (CGI) clinician rating assessing the severity of panic disorder and agoraphobia up to 32 weeks (follow up) No
Primary Panic and Agoraphobia Scale (PAS) 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. up to 32 weeks (follow up) No
Primary Mobility Inventory 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. up to 32 weeks (follow up) No
Primary Number of panic attacks Number of panic attacks experienced during the last week is assessed. up to 32 weeks (follow up) No
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