Differential Effects of in Vivo and Virtual Exposure Therapy in Agoraphobia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJohannes Gutenberg University Mainz
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Therapy
Other interventionCognitive behavioral psychotherapy with exposure
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Virtual reality exposureActive comparator 1 intervention
Group B: In vivo exposureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Extent of Interoceptive Attention
Interoceptive attention assessed via a questionnaires (interoceptive attention/ IA). Higher scores reflect a higher interoceptive attention.
Time frame
through study completion, an average of 2 years2
Extent of Interoceptive Accuracy
Interoceptive accuracy assessed via a questionnaire (interoception accuracy scale/IAS). Higher scores reflect a more accurate/sensitive interoception.
Time frame
through study completion, an average of 2 years3
Extent of Objective Interoceptive Sensitivity
Interoceptive sensitivity assessed via heart rate measures.
Time frame
through study completion, an average of 2 years4
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.
Time frame
through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov