Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder

NCT04568109 | Completed

• 1 other identifier: PA_CBT_HV
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder With Agoraphobia; Panic Disorder Without Agoraphobia

Outcome Measures

Primary Outcomes (4)

• Change in defensive activation to interoceptive threat

  Defensive activation to interoceptive threat (induced via a standardized hyperventilation task) is assessed using the startle eyeblink response (measured via electromyographic activity over the left musculus orbicularis oculi) to an acoustic startle probe.

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in panic symptomatology and severity (PAS)

  The Panic and Agoraphobia Scale (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. Total score range: 0 to 57. Higher scores indicate worse severity of panic symptomatology.

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in the severity of anxiety symptomatology (HAM-A=

  The Hamilton Anxiety Rating Scale (HAM-A) is a structured clinician rating assessing the severity of anxiety symptomatology. Total score rage: 0 to 56. Higher scores indicate worse severity of anxiety symptomatology.

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in anxiety sensitivity (ASI)

  The Anxiety Sensitivity Index (ASI) is a self-report measure of fear of anxiety-related body symptoms (i.e., anxiety sensitivity). Total score range: 0 to 64. Higher scores indicate worse anxiety sensitivity.

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

Secondary Outcomes (5)

• Change in agoraphobic avoidance (MI)

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in Clinical global impression (CGI) (adapted for panic disorder symptomatology)

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in depression symptomatology (BDI)

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in Agoraphobic Cognitions (ACQ)

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

• Change in fear of body symptoms (BSQ)

  change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period

Study Arms (2)

Exposure-based cognitive-behavior therapy

EXPERIMENTAL

Patients are treated in accordance with a manualized protocol (Gloster et al., 2011)

Behavioral: Cognitive-behavior therapy

Wait-List control condition

NO INTERVENTION

Patients are assessed prior to and after a 12-week waiting period. Patients are treated after this 12-week delay.

Interventions

Cognitive-behavior therapy BEHAVIORAL

The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.

Exposure-based cognitive-behavior therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

University of Greifswald

Greifswald, 17487, Germany

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alfons Hamm, Ph.D.

  Department of Psychology, University of Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Christiane Pané-Farré

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 29, 2020
• Study Start: February 1, 2010
• Primary Completion: April 10, 2014
• Study Completion: May 31, 2014
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)