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

NCT03893214 | Unknown

• 1 other identifier: VRAcro
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acrophobia

Keywords

virtual reality exposure therapy; waitlist control design; single session exposure; emotion-driven behavior; respiration

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Acrophobia Questionnaire Follow-up

  Four weeks +/- 3 day after the treatment / placebo intervention

• Sigh Rate

  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

  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

  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

  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)

Other Outcomes (11)

• Anxiety Sensitivity Scale 3 Pre

  Right before the randomization to treatment / placebo condition - within 1 hour before intervention / placebo intervention

• Anxiety Sensitivity Scale 3 Follow-up

  Four weeks +/- 3 day after the treatment / placebo intervention

• Self-Evaluation of Breathing Questionnaire Follow-up

  Four weeks +/- 3 day after the treatment / placebo intervention

Study Arms (2)

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.

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.

Behavioral: virtual reality exposure for acrophobia; Behavioral: movie

Interventions

virtual reality exposure for acrophobia BEHAVIORAL

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.

intervention group; waitlist control group

movie BEHAVIORAL

Participants will watch a movie without height content for the same amount of time as the virtual reality exposure will need.

waitlist control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Equal gender distribution will be ensured because physiological processes and their impact on psychological processes can differ between men and women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed acrophobia
• read, speak and write in German language

You may not qualify if:

• current panic disorder
• lifetime psychotic disorder
• current suicidality
• neurological disorder
• current substance use disorder

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• Ruhr University of Bochum: collaborator

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MeSH Terms

Conditions

Acrophobia; Respiratory Aspiration

Interventions

Motion Pictures

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Dirk Adolph, PhD

  Ruhr-University Bochum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Michalak, PhD

CONTACT

+49 2302 / 926-787; johannes.michalak@uni-wh.de

Naomi Lyons, M.Sc.

CONTACT

+49 2302 / 926-752; naomi.lyons@uni-wh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All roles are aware of the fact that the virtual reality exposure is the primary intervention. No information is given to the participant about the impact of the "video" in the waitlist control group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 28, 2019
• Study Start: April 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: May 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All data will become available for six months with publication.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.