Panic Disorder With AgoraphobiaNCT01680237
Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
A study testing Cognitive behavior therapy and Exposure in-vivo in people with Panic Disorder With Agoraphobia, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety disorders. Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research, studies comparing cognitive-behavioral therapy and exposure in vivo have regularly… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder With Agoraphobia
- What is being tested?
- Cognitive behavior therapy and Exposure in-vivo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Nov 2023
- 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
- Diagnosis of panic disorder with agoraphobia by trained clinician using a structured interview
- The anxiety disorder is considered to be the patient's main current problem
- Age between 18 and 65 years
- The patient has agreed to participate in the study
Who cannot join
- Diagnosis of bipolar disorder, psychotic disorder, alcohol/substance abuse or dependency (within past 3 months), prominent risk of self-harm, organic mental disorder; concurrent psychotherapeutic or psychopharmacological treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentrum für Psychotherapie
Bochum, North Rhine-Westphalia, 44787
About this study
Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety disorders. Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research, studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences. Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia.
Read the detailed description
Anxiety disorders are the most common group of mental illnesses, with lifetime prevalence estimates ranging between 10-30% (Kessler et al 2007). They are an economic burden on society and the sixth largest cause of disability globally (Baxter et al 2014; Fineberg et al 2013). Suffering from an anxiety disorder is distressing, with affected individuals reporting adverse effects on quality of life comparable to sufferers of major depressive disorder, and in excess of the population norm (Mendlowicz and Stein 2000). Panic disorder with agoraphobia is especially prevalent and one of the most handicapping anxiety disorders.
Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research (Sanchez-Meca, Rosa-Alcazar, Marin-Martinez \& Gomez-Conesa, 2010), studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences.
Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia. Participants suffering from panic disorder, agoraphobia receive exposure-based treatment with elements of cognitive restructuring (CBT-group) or without such elements (Exposure-only group) delivered according to treatment manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. Both treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises. In the CBT group identification and correction of maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment package.
- Conditions
- Panic Disorder With Agoraphobia
- Being tested
- Cognitive behavior therapy, Exposure in-vivo
- Keywords
- cognitive behavior therapy, exposure in-vivo, panic disorder with agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapyBehavioural
Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises as well as identification and correction of maladaptive thoughts about anxiety and its consequences.
Exposure in-vivoBehavioural
Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy | Active comparator | 1. Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient
2. Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments
3. Exposure in-vivo
4. Relapse prevention Receives: Behavioral: Cognitive behavior therapy |
| Exposure in-vivo | Active comparator | 1. Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations
2. Exposure with internal stimuli
3. Exposure with external stimuli
4. Relapse prevention
Remark: In this condition there is no active work with the patient's catastrophic cognitions Receives: Behavioral: Exposure in-vivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in the Mobility Inventory
Avoidance Behaviour
Measured: 0, 6, 12 month after treatment
Secondary outcomes (1)
Change (from baseline) in a Behavioral Approach Test
Participants are asked to go up a high and narrow church tower. The test yields number of floors (0-10) the patient achieves, recording the experienced anxiety level (0-100).
Measured: 0, 6, 12 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startOct 2011
- Primary completionNov 2023
- Study completionNov 2023
Why it stopped: Retirement of one of the PIs and participation in another multi center study, within which the same patient inclusion criteria were used.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tobias Teismann, Ruhr University of Bochum
- Investigators
- Tobias Teismann, Dr., Principal investigator, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680237
- Sponsor's protocol ID
- BoSPmA
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2012
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available upon request.
Publications
Sanchez-Meca J, Rosa-Alcazar AI, Marin-Martinez F, Gomez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010 Feb;30(1):37-50. doi: 10.1016/j.cpr.2009.08.011.
PubMed 19775792Kessler RC, Angermeyer M, Anthony JC, DE Graaf R, Demyttenaere K, Gasquet I, DE Girolamo G, Gluzman S, Gureje O, Haro JM, Kawakami N, Karam A, Levinson D, Medina Mora ME, Oakley Browne MA, Posada-Villa J, Stein DJ, Adley Tsang CH, Aguilar-Gaxiola S, Alonso J, Lee S, Heeringa S, Pennell BE, Berglund P, Gruber MJ, Petukhova M, Chatterji S, Ustun TB. Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry. 2007 Oct;6(3):168-76.
PubMed 18188442Baxter AJ, Vos T, Scott KM, Ferrari AJ, Whiteford HA. The global burden of anxiety disorders in 2010. Psychol Med. 2014 Aug;44(11):2363-74. doi: 10.1017/S0033291713003243. Epub 2014 Jan 22.
PubMed 24451993Fineberg NA, Haddad PM, Carpenter L, Gannon B, Sharpe R, Young AH, Joyce E, Rowe J, Wellsted D, Nutt DJ, Sahakian BJ. The size, burden and cost of disorders of the brain in the UK. J Psychopharmacol. 2013 Sep;27(9):761-70. doi: 10.1177/0269881113495118. Epub 2013 Jul 24.
PubMed 23884863Mendlowicz MV, Stein MB. Quality of life in individuals with anxiety disorders. Am J Psychiatry. 2000 May;157(5):669-82. doi: 10.1176/appi.ajp.157.5.669.
PubMed 10784456
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia
- ClinicalTrials.gov ID
- NCT01680237
- Acronym / sponsor ID
- BoSPmA
- Conditions
- Panic Disorder With Agoraphobia
- Keywords
- cognitive behavior therapy, exposure in-vivo, panic disorder with agoraphobia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Retirement of one of the PIs and participation in another multi center study, within which the same patient inclusion criteria were used.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2023 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 7 Sep 2012 (estimated)
- 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.
Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety disorders. Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research, studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences. Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia.
Detailed description
Anxiety disorders are the most common group of mental illnesses, with lifetime prevalence estimates ranging between 10-30% (Kessler et al 2007). They are an economic burden on society and the sixth largest cause of disability globally (Baxter et al 2014; Fineberg et al 2013). Suffering from an anxiety disorder is distressing, with affected individuals reporting adverse effects on quality of life comparable to sufferers of major depressive disorder, and in excess of the population norm (Mendlowicz and Stein 2000). Panic disorder with agoraphobia is especially prevalent and one of the most handicapping anxiety disorders.
Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research (Sanchez-Meca, Rosa-Alcazar, Marin-Martinez \& Gomez-Conesa, 2010), studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences.
Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia. Participants suffering from panic disorder, agoraphobia receive exposure-based treatment with elements of cognitive restructuring (CBT-group) or without such elements (Exposure-only group) delivered according to treatment manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. Both treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises. In the CBT group identification and correction of maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment package.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy | Active comparator | Behavioral: Cognitive behavior therapy1. Identification of bodily sensations, cognitions and safety behaviors characteristic of the individual patient 2. Modification of dysfunctional beliefs and assumptions using socratic questioning and behavioral experiments 3. Exposure in-vivo 4. Relapse prevention |
| Exposure in-vivo | Active comparator | Behavioral: Exposure in-vivo1. Preparation of a brief behavior analysis of the individual case and construction of a hierarchy of relevant (internal and external) phobic situations 2. Exposure with internal stimuli 3. Exposure with external stimuli 4. Relapse prevention Remark: In this condition there is no active work with the patient's catastrophic cognitions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of panic disorder with agoraphobia by trained clinician using a structured interview
- The anxiety disorder is considered to be the patient's main current problem
- Age between 18 and 65 years
- The patient has agreed to participate in the study
Key exclusion criteria (1 listed)
- Diagnosis of bipolar disorder, psychotic disorder, alcohol/substance abuse or dependency (within past 3 months), prominent risk of self-harm, organic mental disorder; concurrent psychotherapeutic or psychopharmacological treatment
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 therapyTreatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises as well as identification and correction of maladaptive thoughts about anxiety and its consequences. | Behavioural | Cognitive behavior therapy |
| Exposure in-vivoTreatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises. | Behavioural | Exposure in-vivo |
Primary outcome
Change (from baseline) in the Mobility Inventory
Time frame: 0, 6, 12 month after treatment
Avoidance Behaviour
1 secondary outcome
Change (from baseline) in a Behavioral Approach Test
Time frame: 0, 6, 12 month after treatment
Results and safety
The study was stopped early (reason given: Retirement of one of the PIs and participation in another multi center study, within which the same patient inclusion criteria were used.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 19775792Sanchez-Meca J, Rosa-Alcazar AI, Marin-Martinez F, Gomez-Conesa A. Psychological treatment of panic disorder with or without agoraphobia: a meta-analysis. Clin Psychol Rev. 2010 Feb;30(1):37-50. doi: 10.1016/j.cpr.2009.08.011.
- Background: PubMed 18188442Kessler RC, Angermeyer M, Anthony JC, DE Graaf R, Demyttenaere K, Gasquet I, DE Girolamo G, Gluzman S, Gureje O, Haro JM, Kawakami N, Karam A, Levinson D, Medina Mora ME, Oakley Browne MA, Posada-Villa J, Stein DJ, Adley Tsang CH, Aguilar-Gaxiola S, Alonso J, Lee S, Heeringa S, Pennell BE, Berglund P, Gruber MJ, Petukhova M, Chatterji S, Ustun TB. Lifetime prevalence and age-of-onset distributions of mental disorders in the World Health Organization's World Mental Health Survey Initiative. World Psychiatry. 2007 Oct;6(3):168-76.
- Background: PubMed 24451993Baxter AJ, Vos T, Scott KM, Ferrari AJ, Whiteford HA. The global burden of anxiety disorders in 2010. Psychol Med. 2014 Aug;44(11):2363-74. doi: 10.1017/S0033291713003243. Epub 2014 Jan 22.
- Background: PubMed 23884863Fineberg NA, Haddad PM, Carpenter L, Gannon B, Sharpe R, Young AH, Joyce E, Rowe J, Wellsted D, Nutt DJ, Sahakian BJ. The size, burden and cost of disorders of the brain in the UK. J Psychopharmacol. 2013 Sep;27(9):761-70. doi: 10.1177/0269881113495118. Epub 2013 Jul 24.
- Background: PubMed 10784456Mendlowicz MV, Stein MB. Quality of life in individuals with anxiety disorders. Am J Psychiatry. 2000 May;157(5):669-82. doi: 10.1176/appi.ajp.157.5.669.
- Individual participant dataSharing planned: Yes. Data will be available upon request.
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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.
Tobias Teismann, Dr. principal investigator
Ruhr University of Bochum
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 and Exposure in-vivo in people with Panic Disorder With Agoraphobia, run by Ruhr University of Bochum 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Apr 2024. 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 was stopped early (reason given: Retirement of one of the PIs and participation in another multi center study, within which the same patient inclusion criteria were used.). Results are not available in the source record.
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 (from baseline) in the Mobility Inventory (time frame: 0, 6, 12 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01680237, which also lists 5 linked publications.
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 11 Apr 2024.