Mechanisms of Panic Disorders Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Panic Disorder Agoraphobia Panic Attacks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exposure with fear augmentation

exposure-based CBT, including interoceptive exposure and in-vivo exposure with fear augmentation by interoceptive exercises (e.g. hyperventilation)

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy (CBT)

Intervention Type BEHAVIORAL

12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure

Exposure without fear augmentation

exposure-based CBT, including interoceptive and in-vivo exposure without fear augmentation during in-vivo exposure

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy (CBT)

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Cognitive Behavioural Therapy (CBT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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University of Greifswald, Department of Clinical Psychology

Principal Investigators

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Alfons O. Hamm, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute for Psychology Ernst-Moritz-Arndt-University Greifswald Franz-Mehring-Str. 47; 17487 Greifswald, Germany

Thomas Lang, Dr.

Role: STUDY_DIRECTOR

Center for Clinical Psychology and Rehabilitation/ Christoph-Dornier-Foundation for Clinical Psychology University Bremen Grazer Str. 2b 28359 Bremen, Germany