AcrophobiaNCT05841329
Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia
A study testing tDCS and virtual reality exposure therapy in people with Acrophobia and Transcranial Direct Current Stimulation, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acrophobia, Transcranial Direct Current Stimulation
- What is being tested?
- tDCS and virtual reality exposure therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2020to 15 Jul 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- the score of the AQ-Anxiety had to be at least 45.45(1SD below the mean of a previous acrophobia sample(Cohen, 1977));
- the participants had the avoidance behaviors in daily life and recognized the fear of height was excessive and unnecessary (the severity of fear of heights not less than 5 points at a scale from 0 to 10).
Who cannot join
- previous treatment for acrophobia, history or family history of any mental disorder (except for acrophobia), metal parts in the head, medical implants, increased intracranial pressure, pregnancy, current involvement in psycho- or pharmacotherapy, and cardiovascular or neurological diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia: A Randomized Controlled Trial
The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights. The main question it aims to answer are:
- the enhancement of tDCS on the effect of VRET Participants will randomly allocated to tDCS active stimulated group and sham stimulated group and receive VRET.
- Being tested
- tDCS, virtual reality exposure therapy
- Keywords
- virtual reality exposure therapy, acrophobia, Transcranial Direct Current Stimulation
- Medical subject headings
- Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
High-definition tDCS (HD-tDCS, 4×1 montage, with 1 anode and 4 cathodes, (Soterix Medical, New York, NY, USA) was applied with battery-driven electrical stimulator (2001\&4×1-C3A). The center electrode was anode and placed over FPz (according to the EEG 10-20 system in order to target the medial prefrontal cortex). The reference electrodes were cathodes and placed over AF7, AF8, F3, F4(see fig. 3). Participants were randomized to receive 20 minutes of active(1.5mA) or sham (0 mA) tDCS in a single-blind design. In order to ensure that participants can gradually adapted to the current change, there was a 15-second current rising process before the stimulation and, a 15-second current falling process after the stimulation. For sham tDCS, the device was automatically turned off after current reached 1.5 mA, thus providing 30s of ramping current stimulation, which made it difficult for participants to distinguish which kinds of stimulation they received.
virtual reality exposure therapyBehavioural
The VRET was adapted on the basis of Öst's single exposure treatment paradigm and conducted by experienced psychotherapists following a standard exposure treatment manual.. An exposure therapy was divided into three parts: psychological education, exposure intervention and summary. Each scene started with a 10-min psychological education followed up with the tDCS stimulation. In exposure trail, participants ought to take an elevator to 100th, observe the environment and look down on the platform. The psychotherapist guided participants to be exposed to the VR environment and helped them experience the process of anxiety decline in the exposure trail.
| Study group | Role | What they receive |
|---|---|---|
| active group | Active comparator | receive active tDCS before VRET Receives: Device: tDCS; Behavioral: virtual reality exposure therapy |
| sham group | Sham comparator | receive sham tDCS before VRET Receives: Behavioral: virtual reality exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acrophobia Questionnaire(AQ)
It consists of two scales that assess fear (Anxiety, ranging from 0 to 120, involving 20 height situations scored on a seven-point Likert scale; Cronbach' α = 0.80) and avoidance behaviors (Avoidance, ranging from 0 to 40, involving 20 height situations scored on a three-point Likert scale; Cronbach' α = 0.70) of height. Each scale contains 20 scenarios about height situation, such as "Standing next to an open window on the third floor". AQ is widely used to measure fear of heights and has good reliability.
Change from Baseline AQ at post-intervention was assessed in the study.
Measured: one day(baseline, after invervention)
Secondary outcomes (4)
Heights Interpretation Questionnaire(HIQ)
This scale is a 16-item self-report questionnaire that are rated on a 5-point Likert scale(1 to 5). It was designed to measure height-relevant interpretations. Total scores range from 16 to 80, with higher scores indicating more height-relevant interpretations.
Change from Baseline HIQ at post-intervention was assessed in the study.
Measured: one day(baseline, after invervention)
State-Trait Anxiety Inventory Form Y, (STAI-Y)
This scale is a 40-item self-report questionnaire that are rated on a 4-point Likert scale(1 to 4). Higher scores indicate more state and trait anxiety.
Change from Baseline STAI-Y at post-intervention was assessed in the study.
Measured: one day(baseline, after invervention)
the Beck Anxiety Inventory(BAI)
It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.
Change from Baseline BAI at post-intervention was assessed in the study.
Measured: one day(baseline, after invervention)
Subjective Units of Distress Scale(SUDS)
This scale is used to assess the level of anxiety with 10 items that are rated from 0-10 point. The higher score indicates more severe current anxiety or distress.
Measured: assessed every five minutes during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start6 Aug 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
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.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841329
- Sponsor's protocol ID
- SMHC-VR-001
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05841329
- Acronym / sponsor ID
- SMHC-VR-001
- Keywords
- virtual reality exposure therapy, acrophobia, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 3 May 2023 (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.
The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights. The main question it aims to answer are:
- the enhancement of tDCS on the effect of VRET Participants will randomly allocated to tDCS active stimulated group and sham stimulated group and receive VRET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active group | Active comparator | Device: tDCS, Behavioral: virtual reality exposure therapyreceive active tDCS before VRET |
| sham group | Sham comparator | Behavioral: virtual reality exposure therapyreceive sham tDCS before VRET |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- the score of the AQ-Anxiety had to be at least 45.45(1SD below the mean of a previous acrophobia sample(Cohen, 1977));
- the participants had the avoidance behaviors in daily life and recognized the fear of height was excessive and unnecessary (the severity of fear of heights not less than 5 points at a scale from 0 to 10).
Key exclusion criteria (1 listed)
- previous treatment for acrophobia, history or family history of any mental disorder (except for acrophobia), metal parts in the head, medical implants, increased intracranial pressure, pregnancy, current involvement in psycho- or pharmacotherapy, and cardiovascular or neurological diseases.
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 |
|---|---|---|
| tDCSHigh-definition tDCS (HD-tDCS, 4×1 montage, with 1 anode and 4 cathodes, (Soterix Medical, New York, NY, USA) was applied with battery-driven electrical stimulator (2001\&4×1-C3A). The center electrode was anode and placed over FPz (according to the EEG 10-20 system in order to target the medial prefrontal cortex). The reference electrodes were cathodes and placed over AF7, AF8, F3, F4(see fig. 3). Participants were randomized to receive 20 minutes of active(1.5mA) or sham (0 mA) tDCS in a single-blind design. In order to ensure that participants can gradually adapted to the current change, there was a 15-second current rising process before the stimulation and, a 15-second current falling process after the stimulation. For sham tDCS, the device was automatically turned off after current reached 1.5 mA, thus providing 30s of ramping current stimulation, which made it difficult for participants to distinguish which kinds of stimulation they received. | Device | active group |
| virtual reality exposure therapyThe VRET was adapted on the basis of Öst's single exposure treatment paradigm and conducted by experienced psychotherapists following a standard exposure treatment manual.. An exposure therapy was divided into three parts: psychological education, exposure intervention and summary. Each scene started with a 10-min psychological education followed up with the tDCS stimulation. In exposure trail, participants ought to take an elevator to 100th, observe the environment and look down on the platform. The psychotherapist guided participants to be exposed to the VR environment and helped them experience the process of anxiety decline in the exposure trail. | Behavioural | active group, sham group |
Primary outcome
Acrophobia Questionnaire(AQ)
Time frame: one day(baseline, after invervention)
It consists of two scales that assess fear (Anxiety, ranging from 0 to 120, involving 20 height situations scored on a seven-point Likert scale; Cronbach' α = 0.80) and avoidance behaviors (Avoidance, ranging from 0 to 40, involving 20 height situations scored on a three-point Likert scale; Cronbach' α = 0.70) of height. Each scale contains 20 scenarios about height situation, such as "Standing next to an open window on the third floor". AQ is widely used to measure fear of heights and has good reliability. Change from Baseline AQ at post-intervention was assessed in the study.
4 secondary outcomes
Heights Interpretation Questionnaire(HIQ)
Time frame: one day(baseline, after invervention)
State-Trait Anxiety Inventory Form Y, (STAI-Y)
Time frame: one day(baseline, after invervention)
the Beck Anxiety Inventory(BAI)
Time frame: one day(baseline, after invervention)
Subjective Units of Distress Scale(SUDS)
Time frame: assessed every five minutes during intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and virtual reality exposure therapy in people with Acrophobia and Transcranial Direct Current Stimulation, run by Shanghai Mental Health Center at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 3 May 2023. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acrophobia Questionnaire(AQ) (time frame: one day(baseline, after invervention)). 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 3 May 2023.