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Agoraphobia; PanicVRExpoNCT06514495

Differential Effects of in Vivo and Virtual Exposure Therapy in Agoraphobia

A study testing Therapy in people with Agoraphobia; Panic and Social Anxiety Disorder, run by Johannes Gutenberg University Mainz at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Anxiety disorders, including agoraphobia, are prevalent in the German population, leading affected individuals to avoid specific places like crowds or public transport. Although cognitive-behavioral therapy with exposure is an effective treatment, many patients resort to medication rather than therapy. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Agoraphobia; Panic, Social Anxiety Disorder
What is being tested?
Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteGermany
Study dates
1 May 2025to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Experimental group: Diagnosis of agoraphobia with or without panic disorder
  • Clinical control group: diagnosis of social phobia
  • Control group: healthy individuals without acute or chronic mental illness
  • A depressive disorder may be present as a comorbid diagnosis in the experimental group and the clinical control group

Who cannot join

  • Other mental illnesses: Substance dependence, schizophrenia, bipolar disorder, dementia, eating disorders, PTSD, major depressive episode, personality disorder
  • Somatic diseases: Cancer, cardiovascular diseases, epilepsy, autoimmune diseases, metabolic or endocrine diseases
  • Taking psychotropic medication (except antidepressants) or medication that affects the cardiovascular system (e.g. beta-blockers), medication containing cortisone, use of creams with corticosteroids
  • Pregnancy, breastfeeding
  • Ongoing psychotherapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanessa Renner, Dr. contact

+4961313920516

vanrenne@uni-mainz.de

Katja Petrowski, Prof. contact

+49613125872

kpetrows@uni-mainz.de

Germany1 site, 1 recruiting
  • University Medical Center

    Mainz, 55122

    Vanessa Renner, Dr., +4961313920516, vanrenne@uni-mainz.de

    Recruiting

Other trials in Germany

About this study

Official title: Differential Effects of in Vivo and Virtual Exposure Therapy on the Interoception and Reactivity of Different Body Systems in Agoraphobia

Anxiety disorders, including agoraphobia, are prevalent in the German population, leading affected individuals to avoid specific places like crowds or public transport. Although cognitive-behavioral therapy with exposure is an effective treatment, many patients resort to medication rather than therapy. Virtual Reality Exposure Therapy (VRET) shows promise in easing exposure treatment with customizable scenarios. Interoception (body symptom perception) and the endocannabinoid system are explored as factors in maintaining agoraphobia. Studies investigate how therapies like exposure (both in vivo and in VR) impact these factors and treatment outcomes. Interoception, especially in panic disorder patients, plays a crucial role, with accurate heartbeat perception linked to maintaining anxiety. The endocannabinoid system, affecting various functions, is studied for its role in therapy outcomes and its modulation of the body's stress response. The study aims to understand how these systems interact in agoraphobic patients and how therapy affects their functionality.

Read the detailed description

Anxiety disorders are among the most common mental illnesses in the German population. Agoraphobia is an anxiety disorder characterized by the avoidance of specific places. Individuals affected by agoraphobia, for example, avoid crowds, public transportation, or traveling far from home, which significantly impacts their daily life. Due to the high psychological distress experienced by those affected, they often seek treatment, making agoraphobia one of the most common diagnoses in outpatient psychotherapy. Cognitive-behavioral therapy with exposure in vivo is considered the "gold standard" of psychotherapeutic treatment for agoraphobia, as it consistently shows high therapeutic effects. However, studies show that 90% of agoraphobic patients take psychotropic medication, and only 17% are in psychotherapeutic treatment. Despite the effectiveness of exposure therapy, it is rarely used in outpatient practice. Based on a survey, only 13-17% of psychotherapists conduct exposure therapy. Other studies indicate that only 8% of agoraphobic patients receive exposure therapy. Due to persistent avoidance behaviors and the limited availability of effective exposure therapy, the suffering and likelihood of chronicity of the condition increase.

Exposure therapy in virtual reality (VR) seems to offer a promising solution to this problem due to its ease of implementation compared to in vivo exposure. By programming anxiety-inducing scenarios for agoraphobic patients in VR, exposure could be conducted with less time and cost. Additionally, it offers other benefits such as the individual customization of anxiety-inducing scenarios. Various studies have already demonstrated the effectiveness of Virtual Reality Exposure Therapy (VRET) in treating various anxiety disorders. In agoraphobic patients, significant reductions in subjectively reported symptoms have been observed, as well as an impact of VRET on psychophysiological measures (e.g., electrodermal activity) indicating physiological arousal during exposure. Both in vivo exposure and VR exposure lead to a reduction in subjective symptoms in agoraphobic patients, and initial effects on psychophysiological parameters (e.g., heart rate variability) have been demonstrated.

Despite the positive effects of in vivo exposure therapy and VRET, agoraphobic symptoms often persist after psychotherapeutic treatment or there is a recurrence of symptoms after initial improvement. Previous studies have identified various factors that could contribute to maintaining the symptoms. In the planned study, interoception and the function of different body systems are the focus as maintaining factors of agoraphobia. It will be investigated how these factors influence treatment outcomes and are influenced by exposure therapies (in vivo vs. VR).

Interception as a maintaining factor of agoraphobia Interoception, the perception of body symptoms, plays a key role in cognitive-behavioral models of mental disorders. In patients with panic disorder (PD), it has been found that they have more accurate cardiac interoceptive rates than healthy controls. Specifically, it has been shown that good heartbeat perception is associated with high relapse rates. In the context of panic attacks, more accurate perception of a rapid heartbeat could contribute to maintaining anxiety. However, this perception could also be (partly) illusory and detached from actual physiology. This dissociation can be assessed in signal detection tasks using the response bias index. To separate interoceptive sensitivity and response bias, a new paradigm applies signal detection theory, allowing for a clear determination of how accurately patients perceive cardiac events. Heart rate variability (HRV) is examined as a marker for cardiac events.

In a previous study, exposure therapy had no impact on the sensitivity of heartbeat perception in both groups. However, the observed null effect could have been caused by neglecting the distinction between interoceptive sensitivity and response bias. In this context, a liberal response strategy has been proposed as a "better safe than sorry" strategy, which can be associated with various psychopathologies. Exposure therapy could contribute to reducing the disconnected physiology in heartbeat perception, thus decreasing the liberal response bias by altering the evaluation of body sensations. In this study, agoraphobic patients with panic disorder and control patients with social anxiety disorder undergo the two heartbeat perception tasks, wherein the sensitivity of heartbeat perception before and after standardized cognitive-behavioral therapy is examined. Additionally, a healthy control group is compared with these two groups regarding the mentioned parameters.

The function of different body systems as a maintaining factor of agoraphobia The endocannabinoid system influences the regulation of various physiological, sensory, motor, emotional, behavioral, and cognitive functions. Patients with panic disorder show increased endocannabinoid concentrations in the blood compared to healthy individuals. How the endocannabinoid system affects the outcome of psychotherapy or is influenced by it remains unclear and will be investigated in the planned study.

The endocannabinoid system modulates the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis. Endocannabinoid release acts to inhibit HPA axis activity, reducing cortisol release under acute stress. Reduced cortisol release under acute stress has been observed in PD patients, and this cortisol release has been linked to therapy outcomes. The HPA axis also influences the immune system and cytokine release. Research has shown the impact of anti-inflammatory cytokines (IL-10) on the avoidance behavior of panic patients post-therapy. Thus, the reactivity of the HPA axis and the immune system influence therapy outcomes and predict the success of therapy. Whether therapy influences these body systems and potentially contributes to the normalization of these systems is currently unclear and will be examined in this study. Through the investigation of the HPA axis, as well as the immune and endocannabinoid systems, insights into the interplay of these body systems in panic patients will be gained.

Being tested
Therapy
Keywords
exposure, virtual reality, interoception, cortisol, immune system, endocannabinoids
Medical subject headings
Agoraphobia, Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TherapyOther

    Cognitive behavioral psychotherapy with exposure

Study groups in NCT06514495
Study groupRoleWhat they receive
Virtual reality exposureActive comparatorAgoraphobic patients receive exposure therapy in virtual reality
Receives: Other: Therapy
In vivo exposureActive comparatorAgoraphobic patients receive exposure therapy in vivo
Receives: Other: Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extent of Interoceptive Attention

    Interoceptive attention assessed via a questionnaires (interoceptive attention/ IA). Higher scores reflect a higher interoceptive attention.

    Measured: through study completion, an average of 2 years

  2. Extent of Interoceptive Accuracy

    Interoceptive accuracy assessed via a questionnaire (interoception accuracy scale/IAS). Higher scores reflect a more accurate/sensitive interoception.

    Measured: through study completion, an average of 2 years

  3. Extent of Objective Interoceptive Sensitivity

    Interoceptive sensitivity assessed via heart rate measures.

    Measured: through study completion, an average of 2 years

  4. Concentration of Bioparameters under rest and under acute stress

    Blood measures of cortisol, immune parameters (IL-6, IL-10), endocannabinoids will be assessed under rest and under acute stress during a Trier Social Stress Test. Unit of measure for all biomarkers is pg/ml.

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2024
  2. Study start1 May 2025
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

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
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06514495
Sponsor's protocol ID
2024-17625
Acronym
VRExpo
Status last verified
Aug 2025
First submitted
2 Jul 2024
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wittchen HU, Jacobi F, Rehm J, Gustavsson A, Svensson M, Jonsson B, Olesen J, Allgulander C, Alonso J, Faravelli C, Fratiglioni L, Jennum P, Lieb R, Maercker A, van Os J, Preisig M, Salvador-Carulla L, Simon R, Steinhausen HC. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol. 2011 Sep;21(9):655-79. doi: 10.1016/j.euroneuro.2011.07.018.

    PubMed 21896369
  • Jakubczyk A, Skrzeszewski J, Trucco EM, Suszek H, Zaorska J, Nowakowska M, Michalska A, Wojnar M, Kopera M. Interoceptive accuracy and interoceptive sensibility in individuals with alcohol use disorder-Different phenomena with different clinical correlations? Drug Alcohol Depend. 2019 May 1;198:34-38. doi: 10.1016/j.drugalcdep.2019.01.036. Epub 2019 Mar 8.

    PubMed 30877955
  • Schandry R. Heart beat perception and emotional experience. Psychophysiology. 1981 Jul;18(4):483-8. doi: 10.1111/j.1469-8986.1981.tb02486.x. No abstract available.

    PubMed 7267933
  • Pohl A, Hums AC, Kraft G, Koteles F, Gerlach AL, Witthoft M. Cardiac interoception: A novel signal detection approach and relations to somatic symptom distress. Psychol Assess. 2021 Aug;33(8):705-715. doi: 10.1037/pas0001012. Epub 2021 Apr 8.

    PubMed 33829843
  • Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.

    PubMed 8255414
  • Griebel G, Stemmelin J, Scatton B. Effects of the cannabinoid CB1 receptor antagonist rimonabant in models of emotional reactivity in rodents. Biol Psychiatry. 2005 Feb 1;57(3):261-7. doi: 10.1016/j.biopsych.2004.10.032.

    PubMed 15691527
  • Kudielka BM, Buske-Kirschbaum A, Hellhammer DH, Kirschbaum C. HPA axis responses to laboratory psychosocial stress in healthy elderly adults, younger adults, and children: impact of age and gender. Psychoneuroendocrinology. 2004 Jan;29(1):83-98. doi: 10.1016/s0306-4530(02)00146-4.

    PubMed 14575731
  • Petrowski K, Herold U, Joraschky P, Wittchen HU, Kirschbaum C. A striking pattern of cortisol non-responsiveness to psychosocial stress in patients with panic disorder with concurrent normal cortisol awakening responses. Psychoneuroendocrinology. 2010 Apr;35(3):414-21. doi: 10.1016/j.psyneuen.2009.08.003. Epub 2009 Nov 12.

    PubMed 19913360
  • Renner V, Conrad R, Kirschbaum C, Lorenz T, Petrowski K. Preliminary results of anti-inflammatory cytokine concentrations predicting therapy outcome in panic disorder. Compr Psychoneuroendocrinol. 2024 Feb 12;17:100227. doi: 10.1016/j.cpnec.2024.100227. eCollection 2024 Feb.

    PubMed 38404508
  • Wechsler TF, Kumpers F, Muhlberger A. Inferiority or Even Superiority of Virtual Reality Exposure Therapy in Phobias?-A Systematic Review and Quantitative Meta-Analysis on Randomized Controlled Trials Specifically Comparing the Efficacy of Virtual Reality Exposure to Gold Standard in vivo Exposure in Agoraphobia, Specific Phobia, and Social Phobia. Front Psychol. 2019 Sep 10;10:1758. doi: 10.3389/fpsyg.2019.01758. eCollection 2019.

    PubMed 31551840

Questions about this trial

What is this clinical trial studying?

A study testing Therapy in people with Agoraphobia; Panic and Social Anxiety Disorder, run by Johannes Gutenberg University Mainz 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 5 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanessa Renner, Dr. (+4961313920516, vanrenne@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of Interoceptive Attention (time frame: through study completion, an average of 2 years). 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?

On the ClinicalTrials.gov record for NCT06514495, which also lists 10 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 3 Sep 2025.

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