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Mechanisms of Panic Disorders Treatment

Mechanisms of CBT-Treatment Effects in Patients With Panic Disorder and Panic Disorder With Agoraphobia: The Role of Interoceptive Exposure

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01323556
Enrollment
180
Registered
2011-03-25
Start date
2010-03-31
Completion date
2012-05-31
Last updated
2011-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agoraphobia, Panic Attacks, Panic Disorder

Keywords

Panic disorder, agoraphobia, panic attacks, exposure based learning, interoceptive exposure exercises, fear augmentation, in vivo exposure

Brief 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

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.

Interventions

BEHAVIORALCognitive Behavioural Therapy (CBT)

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

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
University Medicine Greifswald
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Anxiety Rating Scale (HARS)up to 32 weeks (follow up)structured clinician rating assessing the severity of an anxiety disorder
Clinician Global Impression Scale (CGI)up to 32 weeks (follow up)clinician rating assessing the severity of panic disorder and agoraphobia
Panic and Agoraphobia Scale (PAS)up to 32 weeks (follow up)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 Inventoryup to 32 weeks (follow up)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 attacksup to 32 weeks (follow up)Number of panic attacks experienced during the last week is assessed.

Countries

Germany

Contacts

Primary ContactAlfons O Hamm, PhD
hamm@uni-greifswald.de+49 (0)3834-863716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026