Hypnosis Induction and Height Experience in VR - Control Group Comparison and Three Sessions

NCT06618456 | Active Not Recruiting

• 1 other identifier: 521/2019BO2
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acrophobia

Keywords

Virtual Reality; Hypnosis; Acrophobia; Exposition

Outcome Measures

Primary Outcomes (6)

• Height intervention questionnaire (immediately before the intervention)

  Measurement of acrophobia

  Immediately (circa 1 minute) before the height exposure in all three sessions

• Height intervention questionnaire (immediately after the intervention)

  Measurement of acrophobia

  Immediately (circa 1 minute) after the height exposure in all three sessions

• Height intervention questionnaire (one-week-follow-up)

  Measurement of acrophobia

  One week after the third height exposure

• Height intervention questionnaire (three-months-follow-up)

  Measurement of acrophobia

  Three months after the third height exposure

• Subjective fear rating during height exposure

  Measurement of Fear on Likert scale (0 to 9)

  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)

  at a separate day within the three weeks, where the interventions take place

Secondary Outcomes (2)

• Subjective Scale for Trance Depth

  (circa 5 minutes) after the height exposure in all three sessions

• Igroup Presence Questionaire

  (circa 3 minutes) after the height exposure in all three sessions

Study Arms (2)

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).

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).

Behavioral: VR dive (without Hypnosis); Behavioral: Height exposure

Interventions

VR dive (with Hypnosis) BEHAVIORAL

Participants experience a VR dive through a friendly underwater world. They get a trance induction via audio.

Experimental group

VR dive (without Hypnosis) BEHAVIORAL

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.

Control group

Height exposure BEHAVIORAL

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIQ-Score \> 29
• informed consent

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Milton Erickson Gesellschaft für klinische Hypnose: collaborator
• Milton Erickson Gesellschaft Stiftung: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Acrophobia

Study Officials

• Dirk Revenstorf, Prof.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: October 1, 2024
• Study Start: May 7, 2024
• Primary Completion: July 22, 2024
• Study Completion: October 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: The data will become available when the results are published.

Locations

DE (1)