AcrophobiaNCT03893214
Single Session Virtual Reality Therapy in Acrophobia - and the Role of Respiration
A study testing virtual reality exposure for acrophobia and movie in people with Acrophobia, run by University of Witten/Herdecke.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acrophobia
- What is being tested?
- virtual reality exposure for acrophobia and movie
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosed acrophobia
- read, speak and write in German language
Who cannot join
- current panic disorder
- lifetime psychotic disorder
- current suicidality
- neurological disorder
- current substance use disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Virtual Reality Exposure Therapy for Acrophobia in a Single Session Design and the Role of Respiration for Fear Extinction
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.
Read more
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.
- Conditions
- Acrophobia
- Being tested
- virtual reality exposure for acrophobia, movie
- Keywords
- virtual reality exposure therapy, waitlist control design, single session exposure, emotion-driven behavior, respiration
- Medical subject headings
- Acrophobia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality exposure for acrophobiaBehavioural
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.
movieBehavioural
Participants will watch a movie without height content for the same amount of time as the virtual reality exposure will need.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Behavioral: virtual reality exposure for acrophobia |
| waitlist control group | Placebo comparator | 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. Receives: Behavioral: virtual reality exposure for acrophobia; Behavioral: movie |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 hour after treatment /placebo intervention
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.
Measured: Four weeks +/- 3 day after the treatment / placebo intervention
Secondary outcomes (10)
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.
Measured: Four weeks +/- 3 day after the treatment / placebo intervention
Sigh Rate
Measured with inductive plethysmography and analyzed via ANSLAB
Measured: 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)
Number of Apnoeas
Pauses after inspiration and expiration longer than 5 seconds, measured with inductive plethysmography and analyzed via ANSLAB
Measured: 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)
Respiration Rate
Measured with inductive plethysmography and analyzed via ANSLAB
Measured: 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)
Respiratory Instability
Measured with inductive plethysmography and analyzed via ANSLAB
Measured: 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)
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)
Measured: 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)
Heart Rate
Measured with Electrocardiogram and analyzed via ANSLAB
Measured: 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)
Heart Rate Variability
Measured with Electrocardiogram and analyzed via ANSLAB
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for AcrophobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- Participants are assigned to one of two conditions (virtual reality vs. waitlist control) for the initial phase. In the second phase the waitlist control group receives the virtual reality exposure while the other group does not receive a second intervention.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum
- Responsible party
- Principal investigator, Prof. Dr. Johannes Michalak, University of Witten/Herdecke
- Investigators
- Dirk Adolph, PhD, Principal investigator, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893214
- Sponsor's protocol ID
- VRAcro
- Status last verified
- Apr 2019
- First submitted
- 14 Mar 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected de-identified individual participant data will be shared with other researchers.
Publications
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.
PubMed 28768327Beauchaine 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.
PubMed 26272488Benke 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.
PubMed 28466488Carl 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.
PubMed 30287083Cohen 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.
PubMed 24666248Hautzinger 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.
PubMed 26535473Kemper 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.
PubMed 21182891Margraf 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.
PubMed 26355646Schubert T, Friedmann F, Regenbrecht H. The experience of presence: Factor analytic insights. Presence: Teleoperators & Virtual Environments 10(3): 266-281, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy for Acrophobia in a Single Session Design and the Role of Respiration for Fear Extinction
- ClinicalTrials.gov ID
- NCT03893214
- Acronym / sponsor ID
- VRAcro
- Conditions
- Acrophobia
- Keywords
- virtual reality exposure therapy, waitlist control design, single session exposure, emotion-driven behavior, respiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two conditions (virtual reality vs. waitlist control) for the initial phase. In the second phase the waitlist control group receives the virtual reality exposure while the other group does not receive a second intervention.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: virtual reality exposure for acrophobiaVirtual reality exposure for acrophobia - this arm receives the virtual reality exposure intervention in the initial phase and has a four-week follow-up assessment. |
| waitlist control group | Placebo comparator | Behavioral: virtual reality exposure for acrophobia, Behavioral: movieThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed acrophobia
- read, speak and write in German language
Key exclusion criteria (5 listed)
- current panic disorder
- lifetime psychotic disorder
- current suicidality
- neurological disorder
- current substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality exposure for acrophobiaThe 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. | Behavioural | intervention group, waitlist control group |
| movieParticipants will watch a movie without height content for the same amount of time as the virtual reality exposure will need. | Behavioural | waitlist control group |
Primary outcome
Behavioral Approach Test Post
Time frame: Within 1 hour after treatment /placebo intervention
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.
Behavioral Approach Test Follow-up
Time frame: Four weeks +/- 3 day after the treatment / placebo intervention
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.
10 secondary outcomes
Acrophobia Questionnaire Follow-up
Time frame: Four weeks +/- 3 day after the treatment / placebo intervention
Sigh Rate
Time frame: 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)
Number of Apnoeas
Time frame: 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)
Respiration Rate
Time frame: 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)
Respiratory Instability
Time frame: 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)
Subjective Units of Discomfort Change
Time frame: 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)
Heart Rate
Time frame: 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)
Heart Rate Variability
Time frame: 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)
Skin conductance level
Time frame: 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)
Video recording
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Background: PubMed 28768327Barlow 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.
- Background: PubMed 26272488Beauchaine 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.
- Background: PubMed 28466488Benke 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.
- Background: PubMed 30287083Carl 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.
- BackgroundCohen DC. Comparison of self-report and overt-behavioral procedures for assessing acrophobia. Behavior Therapy 8(1): 17-23, 1977.
- BackgroundCourtney 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.
- Background: PubMed 24666248Diemer 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.
- BackgroundHautzinger M, Keller F, Kühner C. BDI-II - Beck Depressions-Inventar Revision. London: Pearson, 2009.
- Background: PubMed 26535473Jerath 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.
- BackgroundKemper CJ, Ziegler M, Taylor S. Überprüfung der psychometrischen Qualität der deutschen Version des Angstsensitivitätsindex-3. Diagnostica 55(4): 223-233, 2009.
- BackgroundKennedy 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.
- Background: PubMed 21182891Kop 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.
- Individual participant dataSharing planned: Yes. All collected de-identified individual participant data will be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Adolph, PhD principal investigator
Ruhr-University Bochum
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality exposure for acrophobia and movie in people with Acrophobia, run by University of Witten/Herdecke.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Michalak, PhD (+49 2302 / 926-787, johannes.michalak@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Approach Test Post (time frame: Within 1 hour after treatment /placebo intervention). The study lists 2 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 NCT03893214, which also lists 20 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 5 Apr 2019.