AcrophobiaNCT06618456
Hypnosis Induction and Height Experience in VR - Control Group Comparison and Three Sessions
A study testing VR dive (with Hypnosis), VR dive (without Hypnosis) and Height exposure in people with Acrophobia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This study attempts to test wether a VR-supported trance induction and a subsequent exposure to altitude in VR with hypnotic suggestions via Audio reduces acrophobia more than a control-group intervention without trance induction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acrophobia
- What is being tested?
- VR dive (with Hypnosis), VR dive (without Hypnosis) and Height exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- 7 May 2024to Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIQ-Score > 29
- informed consent
Who cannot join
- Negative previous experience with hypnosis
- Negative previous experience with virtual reality
- Mental illness (psychosis, post-traumatic stress disorder and/or personality disorder)
- neurological disease
- Acute or chronic disease (also anamnestic) that may affect brain metabolism:
- pre-existing diabetes mellitus (E10-E14 according to ICD-10)
Show all 9Show fewer
- Renal insufficiency from stage 3 of the Kidney Disease Outcomes Quality Initiative
- Uncontrolled hypertension (I10.x according to ICD-10)
- Moderate or severe traumatic brain injury (GCS 3-12), or traumatic brain injury 2nd or 3rd degree with loss of consciousness of > 30 minutes.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Hypnosis Induction and Height Experience in Virtual Reality - Comparison With Control Group and Investigation of the Effect of Three Sessions
This study attempts to test wether a VR-supported trance induction and a subsequent exposure to altitude in VR with hypnotic suggestions via Audio reduces acrophobia more than a control-group intervention without trance induction. Furthermore the study attempts to test if three sessions of the interventions within three weeks can lead to a stronger reduction of acrophobia than only one session.
Participants will be selected via an online survey according to their score on the Height Interpersonal Questionnaire (HIQ). At the start of the study, participants will be screened by professional clinicians for any mental disorders. In the laboratory they will undergo one of the two interventions in VR (experimental group / control group) and complete questionnaires for three times within three weeks. On a separate day within these three weeks they will be placed in a 30-minute trance to test their suggestibility.
Read the detailed description
Prior to the measurement, those interested in the study will complete a screening questionnaire on acrophobia (HIQ) online. Besides they will be asked if they ever had negative experiences with VR or hypnosis. Only persons who do not report negative experiences with VR or hypnosis and who attain a HIQ score bigger than 29 will be invited to take part in the study. At the first appointment in the laboratory a screening with SCID questions about disorders that would lead to exclusion is conducted. On the basis of this second screening participants will be admitted to the study. Failure to meet the criteria (see eligibility section) will exclude participants from the study. At the start of the assessment session, participants will complete a sociodemographic questionnaire and again the HIQ.
Participants are randomly assigned to one of the two groups. Based on group affiliation they either undergo a VR-supported trance induction or the same VR-program without the trance induction. Then there is an automatic transition to the altitude confrontation. Both groups receive the same VR altitude confrontation, the only difference is that in the experimental group a tree is presented near the participant whereas in the control group a parasol is presented at the same position. Thus the sentences that refer to the tree are changed in the audio of the control group. The height is increased to a maximum of 60 metres. Participants can stop the experiment at any time by pressing a button on a handheld joystick. During the confrontation, various events (e.g. rising balloons) generate additional altitude cues. The duration of the confrontation is approximately 15 minutes. Subsequently participants complete questionnaires about their fear of heights (HIQ) for a post-measurement of altitude anxiety and about their experience of presence (IPQ) and their experience of hypnotic depth (SSTT). Participants will undergo these questionnaires and the intervention three times within three weeks. On a separate day within these three weeks they will be placed in a 30-minute trance and given the Harvard Group Scale of Hypnotic Susceptibility (HGSHS) to test their suggestibility.
The total time required for the participants ist therefore approximately three hours and 15 minutes.
- Conditions
- Acrophobia
- Being tested
- VR dive (with Hypnosis), VR dive (without Hypnosis), Height exposure
- Keywords
- Virtual Reality, Hypnosis, Acrophobia, Exposition
- Medical subject headings
- Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR dive (with Hypnosis)Behavioural
Participants experience a VR dive through a friendly underwater world. They get a trance induction via audio.
VR dive (without Hypnosis)Behavioural
Participants experience a VR dive through a friendly underwater world. They are informed that this part of the VR is a familiarization phase to the VR and they do not get a trance induction.
Height exposureBehavioural
The participants go through a height exposure. They start at the ground level of a virtual city and move upwards in 3 meter steps until they reach a height of 60 meters. Participants focus on a yellow spot on a balcony in front of them, so that they can recognise the depth perimeter.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants undergo an VR-supported trance induction. Participants will see an underwater world adapted to the sound (i.e. text) of the trance. The following exposure will be nearly the same for both groups (see differences in study design). Receives: Behavioral: VR dive (with Hypnosis); Behavioral: Height exposure |
| Control group | Active comparator | Participants see the same underwater world in VR but receive no trance induction. The following exposure will be nearly the same for both groups (see differences in study design). Receives: Behavioral: VR dive (without Hypnosis); Behavioral: Height exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height intervention questionnaire (immediately before the intervention)
Measurement of acrophobia
Measured: Immediately (circa 1 minute) before the height exposure in all three sessions
Height intervention questionnaire (immediately after the intervention)
Measurement of acrophobia
Measured: Immediately (circa 1 minute) after the height exposure in all three sessions
Height intervention questionnaire (one-week-follow-up)
Measurement of acrophobia
Measured: One week after the third height exposure
Height intervention questionnaire (three-months-follow-up)
Measurement of acrophobia
Measured: Three months after the third height exposure
Subjective fear rating during height exposure
Measurement of Fear on Likert scale (0 to 9)
Measured: always 5 seconds after each rise in the height exposure in all three sessions
Harvard Group Scale of Hypnotic Susceptibility (german brief form HGHSH-5)
Measurement of Suggestibility (minimum value = 0, maximum value = 5, higher scores imply higher suggestibility)
Measured: at a separate day within the three weeks, where the interventions take place
Secondary outcomes (2)
Subjective Scale for Trance Depth
Measurement of Trance Depth (minimum value = 38, maximum value = 152, higher scores imply higher subjective trance depth)
Measured: (circa 5 minutes) after the height exposure in all three sessions
Igroup Presence Questionaire
Subjective Presence in the VR-experience (minimum value = -42, maximum value = +42, higher scores imply higher subjective presence)
Measured: (circa 3 minutes) after the height exposure in all three sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start7 May 2024
- Primary completion22 Jul 2024
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of the two groups (experimental group / control group). In the experimental group participants undergo a VR-supported trance induction. The participants in the control group are the same VR-environment but do not receive a trance induction. Then there is an automatic transition to the altitude confrontation (also in VR) in both groups. The experimental group receives hypnotic suggestions via audio, that partially refer to a tree positioned next to the participants in the VR-altitude-confrontation. In the control group this tree is replaced by a parasol in the VR and the text via audio. Besides from that they receive the same text as the experimental group.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Milton Erickson Gesellschaft für klinische Hypnose, Milton Erickson Gesellschaft Stiftung
- Responsible party
- Sponsor
- Investigators
- Dirk Revenstorf, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618456
- Sponsor's protocol ID
- 521/2019BO2
- Status last verified
- Mar 2024
- First submitted
- 7 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In the case of a publication of the results we will share deidentified individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis Induction and Height Experience in Virtual Reality - Comparison With Control Group and Investigation of the Effect of Three Sessions
- ClinicalTrials.gov ID
- NCT06618456
- Acronym / sponsor ID
- 521/2019BO2
- Conditions
- Acrophobia
- Keywords
- Virtual Reality, Hypnosis, Acrophobia, Exposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Milton Erickson Gesellschaft für klinische Hypnose, Milton Erickson Gesellschaft Stiftung
- Study start
- 7 May 2024 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- Oct 2024 (estimated)
- First posted
- 1 Oct 2024 (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.
This study attempts to test wether a VR-supported trance induction and a subsequent exposure to altitude in VR with hypnotic suggestions via Audio reduces acrophobia more than a control-group intervention without trance induction. Furthermore the study attempts to test if three sessions of the interventions within three weeks can lead to a stronger reduction of acrophobia than only one session.
Participants will be selected via an online survey according to their score on the Height Interpersonal Questionnaire (HIQ). At the start of the study, participants will be screened by professional clinicians for any mental disorders. In the laboratory they will undergo one of the two interventions in VR (experimental group / control group) and complete questionnaires for three times within three weeks. On a separate day within these three weeks they will be placed in a 30-minute trance to test their suggestibility.
Detailed description
Prior to the measurement, those interested in the study will complete a screening questionnaire on acrophobia (HIQ) online. Besides they will be asked if they ever had negative experiences with VR or hypnosis. Only persons who do not report negative experiences with VR or hypnosis and who attain a HIQ score bigger than 29 will be invited to take part in the study. At the first appointment in the laboratory a screening with SCID questions about disorders that would lead to exclusion is conducted. On the basis of this second screening participants will be admitted to the study. Failure to meet the criteria (see eligibility section) will exclude participants from the study. At the start of the assessment session, participants will complete a sociodemographic questionnaire and again the HIQ.
Participants are randomly assigned to one of the two groups. Based on group affiliation they either undergo a VR-supported trance induction or the same VR-program without the trance induction. Then there is an automatic transition to the altitude confrontation. Both groups receive the same VR altitude confrontation, the only difference is that in the experimental group a tree is presented near the participant whereas in the control group a parasol is presented at the same position. Thus the sentences that refer to the tree are changed in the audio of the control group. The height is increased to a maximum of 60 metres. Participants can stop the experiment at any time by pressing a button on a handheld joystick. During the confrontation, various events (e.g. rising balloons) generate additional altitude cues. The duration of the confrontation is approximately 15 minutes. Subsequently participants complete questionnaires about their fear of heights (HIQ) for a post-measurement of altitude anxiety and about their experience of presence (IPQ) and their experience of hypnotic depth (SSTT). Participants will undergo these questionnaires and the intervention three times within three weeks. On a separate day within these three weeks they will be placed in a 30-minute trance and given the Harvard Group Scale of Hypnotic Susceptibility (HGSHS) to test their suggestibility.
The total time required for the participants ist therefore approximately three hours and 15 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of the two groups (experimental group / control group). In the experimental group participants undergo a VR-supported trance induction. The participants in the control group are the same VR-environment but do not receive a trance induction. Then there is an automatic transition to the altitude confrontation (also in VR) in both groups. The experimental group receives hypnotic suggestions via audio, that partially refer to a tree positioned next to the participants in the VR-altitude-confrontation. In the control group this tree is replaced by a parasol in the VR and the text via audio. Besides from that they receive the same text as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: VR dive (with Hypnosis), Behavioral: Height exposureParticipants undergo an VR-supported trance induction. Participants will see an underwater world adapted to the sound (i.e. text) of the trance. The following exposure will be nearly the same for both groups (see differences in study design). |
| Control group | Active comparator | Behavioral: VR dive (without Hypnosis), Behavioral: Height exposureParticipants see the same underwater world in VR but receive no trance induction. The following exposure will be nearly the same for both groups (see differences in study design). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIQ-Score > 29
- informed consent
Key exclusion criteria (9 listed)
- Negative previous experience with hypnosis
- Negative previous experience with virtual reality
- Mental illness (psychosis, post-traumatic stress disorder and/or personality disorder)
- neurological disease
- Acute or chronic disease (also anamnestic) that may affect brain metabolism:
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 |
|---|---|---|
| VR dive (with Hypnosis)Participants experience a VR dive through a friendly underwater world. They get a trance induction via audio. | Behavioural | Experimental group |
| VR dive (without Hypnosis)Participants experience a VR dive through a friendly underwater world. They are informed that this part of the VR is a familiarization phase to the VR and they do not get a trance induction. | Behavioural | Control group |
| Height exposureThe participants go through a height exposure. They start at the ground level of a virtual city and move upwards in 3 meter steps until they reach a height of 60 meters. Participants focus on a yellow spot on a balcony in front of them, so that they can recognise the depth perimeter. | Behavioural | Control group, Experimental group |
Primary outcome
Height intervention questionnaire (immediately before the intervention)
Time frame: Immediately (circa 1 minute) before the height exposure in all three sessions
Measurement of acrophobia
Height intervention questionnaire (immediately after the intervention)
Time frame: Immediately (circa 1 minute) after the height exposure in all three sessions
Measurement of acrophobia
Height intervention questionnaire (one-week-follow-up)
Time frame: One week after the third height exposure
Measurement of acrophobia
Height intervention questionnaire (three-months-follow-up)
Time frame: Three months after the third height exposure
Measurement of acrophobia
Subjective fear rating during height exposure
Time frame: always 5 seconds after each rise in the height exposure in all three sessions
Measurement of Fear on Likert scale (0 to 9)
Harvard Group Scale of Hypnotic Susceptibility (german brief form HGHSH-5)
Time frame: at a separate day within the three weeks, where the interventions take place
Measurement of Suggestibility (minimum value = 0, maximum value = 5, higher scores imply higher suggestibility)
2 secondary outcomes
Subjective Scale for Trance Depth
Time frame: (circa 5 minutes) after the height exposure in all three sessions
Igroup Presence Questionaire
Time frame: (circa 3 minutes) after the height exposure in all three sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. In the case of a publication of the results we will share deidentified individual participant data.
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 Revenstorf, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR dive (with Hypnosis), VR dive (without Hypnosis) and Height exposure in people with Acrophobia, run by University Hospital Tuebingen at 1 site in Germany.
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 9 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height intervention questionnaire (immediately before the intervention) (time frame: Immediately (circa 1 minute) before the height exposure in all three sessions). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2024.