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NCT Number: NCT04568109

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

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.

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Key information

Conditions

Panic Disorder With Agoraphobia Panic Disorder Without Agoraphobia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Greifswald

Greifswald, 17487, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in defensive activation to interoceptive threat

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

    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.

  2. Change in panic symptomatology and severity (PAS)

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

    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.

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

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

    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.

  4. Change in anxiety sensitivity (ASI)

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

    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.

Secondary outcomes

  1. Change in agoraphobic avoidance (MI)

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

    Mobility inventory (MI) is a self-report measure that assess agoraphobic avoidance. Total score range: 1 to 5. Higher scores indicate worse agoraphobic avoidance.

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

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

    Clinical global impression scale (CGI) is a clinician rated global panic disorder severity measure. Total score range: 1 to 7. Higher scores indicate worse global panic disorder severity.

  3. Change in depression symptomatology (BDI)

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

    Beck Depression Inventory (BDI) measures depressive symptomatology (self-report measure). Total score range: 0 to 63. Higher scores indicate worse depressive symptomatology.

  4. Change in Agoraphobic Cognitions (ACQ)

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

    Agoraphobic Cognitions Questionnaire (ACQ) is a self-report measure assessing agoraphobic cognitions. Total score range: 1 to 5. Higher scores indicate worse agoraphobic cognitions.

  5. Change in fear of body symptoms (BSQ)

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

    Self reported fear of body symptoms is measured using the Body Sensation Questionnaire (BSQ). Total score range: 17 to 85. Higher scores indicate worse fear of anxiety sen.

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2020
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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