Single Session Virtual Reality Therapy in Acrophobia - and the Role of Respiration

Acrophobia Clinical Trial

Official title:

Virtual Reality Exposure Therapy for Acrophobia in a Single Session Design and the Role of Respiration for Fear Extinction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03893214
• Other study ID #: VRAcro
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: April 2019
• Source: University of Witten/Herdecke
• Contact: Johannes Michalak, PhD
• Phone: +49 2302 / 926-787
• Email: johannes.michalak[@]uni-wh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent years, in the treatment of phobias, exposure therapy in virtual reality is becoming more and more popular as an alternative for in-vivo exposure. Effectiveness of virtual reality exposure therapy (VRET) is comparable to in-vivo exposure therapy, though several characteristics of the VRET have an impact on the outcome of the therapy (e.g., immersion into the virtual environment (VE), familiarity with the VE). Additionally, the use of VRET varies from multiple exposure sessions to single-session VRET. Single-session therapy has an economic advantage and in in-vivo, post therapy outcomes show good results. In virtual reality, the assessment of outcome post therapy and in follow-up of single-session therapies is still needed for an evaluation of this approach. As an outcome measure, behavioral assessments are especially relevant for effectiveness studies as in fear of heights it is closer to the individual's life to know how high they voluntarily go up a building than to have hypothetical self-report questionnaire results.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosed acrophobia

• read, speak and write in German language

Exclusion Criteria:

• current panic disorder

• lifetime psychotic disorder

• current suicidality

• neurological disorder

• current substance use disorder

Related Conditions & MeSH terms

• Acrophobia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Witten/Herdecke	Ruhr University of Bochum

References & Publications (20)

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. — View Citation

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. Review. — View Citation

Benke C, Hamm AO, Pané-Farré 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. — View Citation

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. — View Citation

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, Mühlberger 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Margraf J, Cwik JC. Mini-DIPS - Open Access - Diagnostisches Kurzinterview bei psychischen Störungen. 2017.

Morina N, Ijntema H, Meyerbröker 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Wolpe J, Lazarus AA. Behavior therapy techniques: A guide to the treatment of neuroses.1966.

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety Sensitivity Scale 3 Pre	Questionnaire by Kemper, Ziegler & Taylor (2009); Scale ranges from 0 - very little to 4 - very much; a total maximum score is 64 and a minimum 0 with a higher score indicating more anxiety sensitivity.	Right before the randomization to treatment / placebo condition - within 1 hour before intervention / placebo intervention
Other	Anxiety Sensitivity Scale 3 Follow-up	Questionnaire by Kemper, Ziegler & Taylor (2009); Scale ranges from 0 - very little to 4 - very much; a total maximum score is 64 and a minimum 0 with a higher score indicating more anxiety sensitivity.	Four weeks +/- 3 day after the treatment / placebo intervention
Other	Self-Evaluation of Breathing Questionnaire Follow-up	Questionnaire by Courtney & Greenwood (2009) - translated with backtranslation by the author. The scale ranges from 0 - never to 3 - very often with a higher score indicating more breathing dirsturbances. A total maximum score is 75 and minimum 0.	Four weeks +/- 3 day after the treatment / placebo intervention
Other	Self-Evaluation of Breathing Questionnaire Pre	Questionnaire by Courtney & Greenwood (2009) - translated with backtranslation by the author. The scale ranges from 0 - never to 3 - very often with a higher score indicating more breathing dirsturbances. A total maximum score is 75 and minimum 0.	Right before the randomization to treatment / placebo condition - within 1 hour before intervention / placebo intervention
Other	Beck Depression Inventory II Follow-up	Questionnaire by Beck, Steer & Brown (2001), German version by Hautzinger, Keller & Kühner (2009). The scale ranges from 0 to 3 with a higher score indicating more depressive symptoms. A total maximum score is 60 and minimum score 0.	Four weeks +/- 3 day after the treatment / placebo intervention
Other	Beck Depression Inventory II Pre	Questionnaire by Beck, Steer & Brown (2001), German version by Hautzinger, Keller & Kühner (2009). The scale ranges from 0 to 3 with a higher score indicating more depressive symptoms. A total maximum score is 60 and minimum score 0.	Right before the randomization to treatment / placebo condition - within 1 hour before intervention / placebo intervention
Other	Igroup Presence Questionnaire	Questionnaire by Schubert, Friedmann & Regenbrecht (2001) to measure the feeling of presence in the virtual reality. Scale ranges from -3 - not at all to +3 - a lot with a total maximum score of 42 and minimum -42. A higher scores indicates a higher feeling of presence in the virtual reality.	Within 30 minutes after virtual reality exposure (treatment)
Other	Simulator Sickness Questionnaire	Questionnaire by Kennedy, Lane, Berbaum & Lilienthal (1993) to measure simulator sickness in the virtual reality. Scale ranges from 0 - not at all to 3 - strongly with a total maximum score of 48 and minimum 0. A higher scores indicates a higher feeling of simulator sickness in the virtual reality.	Within 30 minutes after virtual reality exposure (treatment)
Other	Mini-DIPS (Diagnostisches Interview bei psychischen Störungen; english: diagnostic interview of mental disorders)	Diagnostic interview to diagnose acrophobia and to exclude panic disorder. Interview by Margraf & Cwik (2017)	Within a month before the treatment / placebo intervention
Other	Behavioral Approach Test Pre	Participants are asked to walk up fire exit stairs of the university building where the treatment is applied. The number of steps upstairs is counted as dependent measure. BAT pre is assessed in order to ensure an effective randomization.	Right before the randomization to treatment / placebo condition - within 1 hour before treatment or placebo intervention
Other	Acrophobia Questionnaire Pre	Questionnaire by Cohen (1977); Screening for people with fear of hights and in order to ensure an effective randomization. The scale ranges from 0 - not at all frightening to 6 - very frightening with a higher score indicating more anxiety. A total maximum score is 120 and minimum score 0.	Within a month before the treatment / placebo intervention
Primary	Behavioral Approach Test Post	Participants are asked to walk up fire exit stairs of the university building where the treatment is applied. The number of steps upstairs is counted as dependent measure.	Within 1 hour after treatment /placebo intervention
Primary	Behavioral Approach Test Follow-up	Participants are asked to walk up fire exit stairs of the university building where the treatment is applied. The number of steps upstairs is counted as dependent measure.	Four weeks +/- 3 day after the treatment / placebo intervention
Secondary	Acrophobia Questionnaire Follow-up	Questionnaire by Cohen (1977); The scale ranges from 0 - not at all frightening to 6 - very frightening with a higher score indicating more anxiety. A total maximum score is 120 and minimum score 0.	Four weeks +/- 3 day after the treatment / placebo intervention
Secondary	Sigh Rate	Measured with inductive plethysmography and analyzed via ANSLAB	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Number of Apnoeas	Pauses after inspiration and expiration longer than 5 seconds, measured with inductive plethysmography and analyzed via ANSLAB	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Respiration Rate	Measured with inductive plethysmography and analyzed via ANSLAB	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Respiratory Instability	Measured with inductive plethysmography and analyzed via ANSLAB	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Subjective Units of Discomfort Change	Participants are asked how fearful they are on a scale from 0 to 10. Original scale by Wolpe & Lazarus (1966)	During virtual reality exposure session, at baseline (1; minute 1), on each floor of the tower (2-14; between minute 6 and 44) and in recovery phase (15; minute 50)
Secondary	Heart Rate	Measured with Electrocardiogram and analyzed via ANSLAB	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Heart Rate Variability	Measured with Electrocardiogram and analyzed via ANSLAB	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Skin conductance level	Skin conductance is recorded continuously with two electrodes placed on the medial phalanxes of the index and middle fingers of the nondominant hand.	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)
Secondary	Video recording	A rating system for signs of muscular tension during virtual reality exposure will be designed. Therefore, in a first step it will be assessed whether signs of muscular tension are visible overall. In a second step, all signs from up to 10 randomly picked participants will be noted from two different raters in order to design a rating scale. This scale will then be applied to the rest of the participants by 2 independent raters and finally correlated with the post outcome measures and follow-up outcome measures.	During virtual reality exposure session, at baseline (1; 5 minutes), on each floor of the tower (2-14; 3 minutes, in total 39 minutes) and in recovery phase (15; 5 minutes)