Clinical trial NCT04568109: Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
Official title: Effect of Cognitive-behavior Therapy on Panic Symptomatology and the Activation of the Brain's Fear Network to Panic-related Body Symptoms in Patients With Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic Disorder With Agoraphobia
Panic Disorder Without Agoraphobia
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2020-09-29
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study aims to investigate a potential mechanism of successful CBT for panic disorder, i.e., the reduction of excessive anxious apprehension and fear responses to panic-related body symptoms in the context of CBT treatment. In the present non-randomized interventional study, effects of cognitive behavior therapy on reported symptoms and fear responses to panic-related body symptoms are investigated. It is expected that symptom improvement during CBT is associated with a decrease in the activation of the brain's fear network to panic-related body symptoms.

Detailed description: Changes in fear responses to body symptoms in the course of CBT are investigated in patients with PD by applying a highly standardized hyperventilation task (provoking panic-related body symptoms) prior to and after a manualized CBT or a waiting period. Activation of the brain's fear network (defensive activation) is indexed by the potentiation of the startle eyeblink response.

Eligibility criteria: Inclusion Criteria:

* current primary diagnosis of panic disorder (with or without agoraphobia) as defined by the criteria of the diagnostic and statistical manual, fourth revision/text revision (DSM-IV-TR) (determined using the Composite International Diagnostic Interview and verified by a certified psychotherapist)
* age 18 - 65 years

Exclusion Criteria:

* current suicidal intent
* any psychotic or bipolar disorder
* borderline personality disorder
* a medical condition that could explain patients' symptoms
* physical contradictions regarding application of exposure-based CBT (e.g., neurological disease)
* Patients has to be on a stable psychopharmacological medication schedule prior to study entry for at least 12 weeks
* Intake of benzodiazepines

Primary outcomes:
measure: Change in defensive activation to interoceptive threat
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in panic symptomatology and severity (PAS)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in the severity of anxiety symptomatology (HAM-A=
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in anxiety sensitivity (ASI)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Secondary outcomes:
measure: Change in agoraphobic avoidance (MI)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in Clinical global impression (CGI) (adapted for panic disorder symptomatology)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in depression symptomatology (BDI)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in Agoraphobic Cognitions (ACQ)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
measure: Change in fear of body symptoms (BSQ)
timeFrame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University of Greifswald
Study officials:
affiliation: Department of Psychology, University of Greifswald
name: Alfons Hamm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: