Panic Disorder With AgoraphobiaNCT04568109
Effect of Cognitive-behavior Therapy on Fear Responses to Body Symptoms in Patients With Panic Disorder
A study testing Cognitive-behavior therapy in people with Panic Disorder With Agoraphobia and Panic Disorder Without Agoraphobia, run by Philipps University Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia
- What is being tested?
- Cognitive-behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2010to 31 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Cognitive-behavior therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavior therapyBehavioural
The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exposure-based cognitive-behavior therapy | Experimental | Patients are treated in accordance with a manualized protocol (Gloster et al., 2011) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Secondary outcomes (5)
Change in agoraphobic avoidance (MI)
Mobility inventory (MI) is a self-report measure that assess agoraphobic avoidance. Total score range: 1 to 5. Higher scores indicate worse agoraphobic avoidance.
Measured: 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)
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.
Measured: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in depression symptomatology (BDI)
Beck Depression Inventory (BDI) measures depressive symptomatology (self-report measure). Total score range: 0 to 63. Higher scores indicate worse depressive symptomatology.
Measured: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in Agoraphobic Cognitions (ACQ)
Agoraphobic Cognitions Questionnaire (ACQ) is a self-report measure assessing agoraphobic cognitions. Total score range: 1 to 5. Higher scores indicate worse agoraphobic cognitions.
Measured: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in fear of body symptoms (BSQ)
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.
Measured: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Feb 2010
- Primary completion10 Apr 2014
- Study completion31 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic Disorder With AgoraphobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Christane Pané-Farré, Philipps University Marburg
- Investigators
- Alfons Hamm, Ph.D., Principal investigator, Department of Psychology, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568109
- Sponsor's protocol ID
- PA_CBT_HV
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04568109
- Acronym / sponsor ID
- PA_CBT_HV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 10 Apr 2014 (actual)
- Study completion
- 31 May 2014 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure-based cognitive-behavior therapy | Experimental | Behavioral: Cognitive-behavior therapyPatients are treated in accordance with a manualized protocol (Gloster et al., 2011) |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavior therapyThe manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises. | Behavioural | Exposure-based cognitive-behavior therapy |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Change in agoraphobic avoidance (MI)
Time frame: 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)
Time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in depression symptomatology (BDI)
Time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in Agoraphobic Cognitions (ACQ)
Time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Change in fear of body symptoms (BSQ)
Time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfons Hamm, Ph.D. principal investigator
Department of Psychology, University of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavior therapy in people with Panic Disorder With Agoraphobia and Panic Disorder Without Agoraphobia, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in defensive activation to interoceptive threat (time frame: change from pre-intervention/pre-waiting period (baseline) to immediately after CBT or waiting period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.