Mechanisms of Panic Disorders Treatment

University Medicine Greifswald

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Panic Disorder; Panic Attacks; Agoraphobia

Treatments: Behavioral: Cognitive Behavioural Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01323556

AH 11.2009

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Exposure with fear augmentation

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioural Therapy (CBT)

Behavioral: Cognitive Behavioural Therapy (CBT)

Exposure without fear augmentation

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioural Therapy (CBT)

Behavioral: Cognitive Behavioural Therapy (CBT)