Differential Effects of in Vivo and Virtual Exposure Therapy in Agoraphobia

NCT06514495 | Recruiting

• 1 other identifier: 2024-17625
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Agoraphobia; Panic; Social Anxiety Disorder

Keywords

exposure; virtual reality; interoception; cortisol; immune system; endocannabinoids

Outcome Measures

Primary Outcomes (4)

• Extent of Interoceptive Attention

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

  through study completion, an average of 2 years

• Extent of Interoceptive Accuracy

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

  through study completion, an average of 2 years

• Extent of Objective Interoceptive Sensitivity

  Interoceptive sensitivity assessed via heart rate measures.

  through study completion, an average of 2 years

• 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.

  through study completion, an average of 2 years

Study Arms (2)

Virtual reality exposure

ACTIVE COMPARATOR

Agoraphobic patients receive exposure therapy in virtual reality

Other: Therapy

In vivo exposure

ACTIVE COMPARATOR

Agoraphobic patients receive exposure therapy in vivo

Other: Therapy

Interventions

Therapy OTHER

Cognitive behavioral psychotherapy with exposure

In vivo exposure; Virtual reality exposure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Medical Center

Mainz, 55122, Germany

RECRUITING

Related Publications (10)

• 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.

  PMID: 21896369 BACKGROUND

• 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.

  PMID: 30877955 BACKGROUND

• 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.

  PMID: 7267933 BACKGROUND

• 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.

  PMID: 33829843 BACKGROUND

• 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.

  PMID: 8255414 BACKGROUND

• 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.

  PMID: 15691527 BACKGROUND

• 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.

  PMID: 14575731 BACKGROUND

• 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.

  PMID: 19913360 BACKGROUND

• 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.

  PMID: 38404508 BACKGROUND

• 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.

  PMID: 31551840 BACKGROUND

MeSH Terms

Conditions

Agoraphobia; Phobia, Social

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Katja Petrowski, Prof,

  University Medical Center of the Johannes Gutenberg University Mainz

  STUDY CHAIR

Central Study Contacts

Vanessa Renner, Dr.

CONTACT

+4961313920516; vanrenne@uni-mainz.de

Katja Petrowski, Prof.

CONTACT

+49613125872; kpetrows@uni-mainz.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 23, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)