Single Session Virtual Reality Therapy in Acrophobia - and the Role of Respiration
NCT ID: NCT03893214
Last Updated: 2019-04-05
Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-04-01
2020-05-01
Brief Summary
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Much research has been conducted on physiological correlates of the subjective experience of fear in exposure therapy as they are assumed to be a prerequisite for effective exposure treatment. Skin conductance level (SCL) and heart rate can be used for objective manipulation checks of exposure therapy. SCL is found to increase during fearful situations independent of setting while heart rate only increases during in-vivo exposure. Contrary to heart rate, heart rate variability (HRV) is not thoroughly studied in VRET yet. HRV is associated with the adaptability of an organism to new environments and cognitive functioning. High Frequency HRV is found to be reduced in individuals with mental disorders, and positive and negative mood inductions lead to differential HRV responses overall.
Respiration is a well-studied correlate of emotional experience and especially of the experience of fear and anxiety. In a series of experiments, it was found that sighing is tightly associated with relief in or after fearful or stressful situations and might become maladaptive when used disproportionally often. This study shows that respiration parameters have an impact on the handling of fearful situations in a reciprocal way. On the one hand, fear leads to an increased respiration rate and sigh rate while on the other hand, an altered sigh rate or respiration rate might have an impact on the experience of fear and be used as a defensive reaction to a fearful situation. As such, specific respiration patterns might act as emotion-driven behaviors (EDB). EDBs are responses to emotions that result in a short-term reduction of a negative state while in long-term support the maintenance of the phobia.
The aim of this study is to examine the effectiveness of a single-session VRET for acrophobia with a multimethod outcome design. Familiarity of the setting will be high with the use of a well-known tower in this area. Immersion into the VE will be assessed with a presence questionnaire. For a manipulation check, physiological data will be assessed, i.e., SCL, heart rate and HRV. Primary outcome measure will be a behavioral approach test (BAT) as behavioral assessment. Additionally, after four weeks, a follow-up assessment will investigate the stability of the effectiveness of the VRET in comparison to a waitlist control group. A second aim of this study is to investigate the impact of respiration as an EDB on the effectiveness of an exposure therapy. Therefore, the association between respiration and outcome of the VRET will be analyzed.
Hypothesis 1: Participants in the VRET condition show less height avoidance in the BAT after the intervention than participants in the control condition.
Hypothesis 2: Participants in the VRET condition show less height avoidance in the BAT in a four-week follow-up assessment than participants in the control condition.
Hypothesis 3: Participants in the VRET condition score significantly lower on the Acrophobia Questionnaire at follow-up than participants in the control condition.
Hypothesis 4: During the VRET, breath holding is used as EDB. Participants that hold their breath, profit less from the VRET than participants that do not hold their breath.
Hypothesis 5: During the VRET, sighing is used as EDB. Participants that sigh, profit less from the VRET than participants that do not sigh.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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intervention group
Virtual reality exposure for acrophobia - this arm receives the virtual reality exposure intervention in the initial phase and has a four-week follow-up assessment.
virtual reality exposure for acrophobia
The setting of the virtual reality is the "Gasometer Oberhausen", Europe's largest disc-type gas container which is one of the most famous high buildings in the area. After a baseline phase, participants will undergo a gradual exposure. Participants will first look up to the building and then be guided upstairs to have an exposure phase on 11 floors. On the highest floor they will walk around a gallery. In the end, there will be a recovery phase.
waitlist control group
This arm watches a movie in the initial phase in order to control for effects of behavioral approach test that is done before and after the intervention and for time effects. In the second phase after four weeks, this arm receives the virtual reality exposure after collection of outcome measures.
virtual reality exposure for acrophobia
The setting of the virtual reality is the "Gasometer Oberhausen", Europe's largest disc-type gas container which is one of the most famous high buildings in the area. After a baseline phase, participants will undergo a gradual exposure. Participants will first look up to the building and then be guided upstairs to have an exposure phase on 11 floors. On the highest floor they will walk around a gallery. In the end, there will be a recovery phase.
movie
Participants will watch a movie without height content for the same amount of time as the virtual reality exposure will need.
Interventions
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virtual reality exposure for acrophobia
The setting of the virtual reality is the "Gasometer Oberhausen", Europe's largest disc-type gas container which is one of the most famous high buildings in the area. After a baseline phase, participants will undergo a gradual exposure. Participants will first look up to the building and then be guided upstairs to have an exposure phase on 11 floors. On the highest floor they will walk around a gallery. In the end, there will be a recovery phase.
movie
Participants will watch a movie without height content for the same amount of time as the virtual reality exposure will need.
Eligibility Criteria
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Inclusion Criteria
* read, speak and write in German language
Exclusion Criteria
* lifetime psychotic disorder
* current suicidality
* neurological disorder
* current substance use disorder
18 Years
65 Years
ALL
Yes
Sponsors
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Ruhr University of Bochum
OTHER
University of Witten/Herdecke
OTHER
Responsible Party
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Prof. Dr. Johannes Michalak
Full Professor
Principal Investigators
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Dirk Adolph, PhD
Role: PRINCIPAL_INVESTIGATOR
Ruhr-University Bochum
Central Contacts
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References
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Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11.
Benke C, Hamm AO, Pane-Farre CA. When dyspnea gets worse: Suffocation fear and the dynamics of defensive respiratory responses to increasing interoceptive threat. Psychophysiology. 2017 Sep;54(9):1266-1283. doi: 10.1111/psyp.12881. Epub 2017 May 3.
Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, Asmundson GJG, Carlbring P, Powers MB. Virtual reality exposure therapy for anxiety and related disorders: A meta-analysis of randomized controlled trials. J Anxiety Disord. 2019 Jan;61:27-36. doi: 10.1016/j.janxdis.2018.08.003. Epub 2018 Aug 10.
Cohen DC. Comparison of self-report and overt-behavioral procedures for assessing acrophobia. Behavior Therapy 8(1): 17-23, 1977.
Courtney R, Greenwood KM. Preliminary investigation of a measure of dysfunctional breathing symptoms: The Self Evaluation of Breathing Questionnaire (SEBQ). International Journal of Osteopathic Medicine 12(4): 121-127, 2009.
Diemer J, Muhlberger A, Pauli P, Zwanzger P. Virtual reality exposure in anxiety disorders: impact on psychophysiological reactivity. World J Biol Psychiatry. 2014 Aug;15(6):427-42. doi: 10.3109/15622975.2014.892632. Epub 2014 Mar 25.
Hautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar Revision. London: Pearson, 2009.
Jerath R, Crawford MW. How Does the Body Affect the Mind? Role of Cardiorespiratory Coherence in the Spectrum of Emotions. Adv Mind Body Med. 2015 Fall;29(4):4-16.
Kemper CJ, Ziegler M, Taylor S. Überprüfung der psychometrischen Qualität der deutschen Version des Angstsensitivitätsindex-3. Diagnostica 55(4): 223-233, 2009.
Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG. Simulator Sickness Questionnaire: An Enhanced Method for Quantifying Simulator Sickness. The International Journal of Aviation Psychology 3(3): 203-220, 1993.
Kop WJ, Synowski SJ, Newell ME, Schmidt LA, Waldstein SR, Fox NA. Autonomic nervous system reactivity to positive and negative mood induction: the role of acute psychological responses and frontal electrocortical activity. Biol Psychol. 2011 Mar;86(3):230-8. doi: 10.1016/j.biopsycho.2010.12.003. Epub 2010 Dec 21.
Margraf J, Cwik JC. Mini-DIPS - Open Access - Diagnostisches Kurzinterview bei psychischen Störungen. 2017.
Morina N, Ijntema H, Meyerbroker K, Emmelkamp PM. Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. Behav Res Ther. 2015 Nov;74:18-24. doi: 10.1016/j.brat.2015.08.010. Epub 2015 Aug 31.
Schubert T, Friedmann F, Regenbrecht H. The experience of presence: Factor analytic insights. Presence: Teleoperators & Virtual Environments 10(3): 266-281, 2001.
Steer RA, Brown GK, Beck AT, Sanderson WC. Mean Beck Depression Inventory-II scores by severity of major depressive episode. Psychol Rep. 2001 Jun;88(3 Pt 2):1075-6. doi: 10.2466/pr0.2001.88.3c.1075.
Vlemincx E, Van Diest I, De Peuter S, Bresseleers J, Bogaerts K, Fannes S, Li W, Van Den Bergh O. Why do you sigh? Sigh rate during induced stress and relief. Psychophysiology. 2009 Sep;46(5):1005-13. doi: 10.1111/j.1469-8986.2009.00842.x. Epub 2009 May 21.
Wilhelm FH, Gevirtz R, Roth WT. Respiratory dysregulation in anxiety, functional cardiac, and pain disorders. Assessment, phenomenology, and treatment. Behav Modif. 2001 Sep;25(4):513-45. doi: 10.1177/0145445501254003.
Wolitzky-Taylor KB, Horowitz JD, Powers MB, Telch MJ. Psychological approaches in the treatment of specific phobias: a meta-analysis. Clin Psychol Rev. 2008 Jul;28(6):1021-37. doi: 10.1016/j.cpr.2008.02.007. Epub 2008 Mar 7.
Wolpe J, Lazarus AA. Behavior therapy techniques: A guide to the treatment of neuroses.1966.
Other Identifiers
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VRAcro
Identifier Type: -
Identifier Source: org_study_id
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