Fear of HeightsNCT02361203
Exercise and Virtual Reality Exposure Therapy for Acrophobia
A study testing Exercise in people with Fear of Heights, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Heights
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2016
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 25
- Speaks English fluently
- Score of 80 or higher on the Acrophobia Questionnaire
- SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear
- Passes the Physical Activity Readiness Questionnaire-Plus
Who cannot join
- Hearing or visually impaired
- Currently receiving exposure-based treatment for acrophobia
- Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating < 50
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.
- Conditions
- Fear of Heights
- Being tested
- Exercise
- Medical subject headings
- Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| No Exercise | No intervention | Not described |
| Exercise Pre | Experimental | 30 minutes of aerobic exercise before exposure therapy Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear scores
Change in fear scores using subjective units of distress will be assessed.
Measured: 7 (+/- 3) days after exposure therapy
Perceived threat likelihood scores
Change in the perception of threat likelihood on a scale from 1-5 will be assessed.
Measured: 7 (+/- 3) days after exposure therapy
Secondary outcomes (5)
Skin conductance fluctuations
Changes in skin conductance fluctuations will be assessed.
Measured: 7 (+/- 3) days after exposure therapy
Heart rate fluctuations
Heart rate fluctuations will be assessed.
Measured: 7 (+/- 3) days after exposure therapy
Acrophobia Severity
Change in score on the Acrophobia Questionnaire
Measured: 14 (+/- 3) days after exposure therapy
Attitudes Toward Heights
Change in score on the Attitudes Toward Heights Inventory
Measured: 14 (+/- 3) days after exposure therapy
Clinical Global Improvement
Change in score on the Clinical Global Improvement Scale
Measured: 14 (+/- 3) days after exposure therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of HeightsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolene Jacquart, University of Texas at Austin
- Investigators
- Jasper Smits, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361203
- Sponsor's protocol ID
- 2014-12-0037
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Virtual Reality Exposure Therapy for Acrophobia
- ClinicalTrials.gov ID
- NCT02361203
- Acronym / sponsor ID
- 2014-12-0037
- Conditions
- Fear of Heights
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Feb 2015 (estimated)
- 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 purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Exercise | No intervention | – |
| Exercise Pre | Experimental | Behavioral: Exercise30 minutes of aerobic exercise before exposure therapy |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 25
- Speaks English fluently
- Score of 80 or higher on the Acrophobia Questionnaire
- SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear
- Passes the Physical Activity Readiness Questionnaire-Plus
Key exclusion criteria (3 listed)
- Hearing or visually impaired
- Currently receiving exposure-based treatment for acrophobia
- Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating < 50
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 |
|---|---|---|
| Exercise30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve. | Behavioural | Exercise Pre |
Primary outcome
Fear scores
Time frame: 7 (+/- 3) days after exposure therapy
Change in fear scores using subjective units of distress will be assessed.
Perceived threat likelihood scores
Time frame: 7 (+/- 3) days after exposure therapy
Change in the perception of threat likelihood on a scale from 1-5 will be assessed.
5 secondary outcomes
Skin conductance fluctuations
Time frame: 7 (+/- 3) days after exposure therapy
Heart rate fluctuations
Time frame: 7 (+/- 3) days after exposure therapy
Acrophobia Severity
Time frame: 14 (+/- 3) days after exposure therapy
Attitudes Toward Heights
Time frame: 14 (+/- 3) days after exposure therapy
Clinical Global Improvement
Time frame: 14 (+/- 3) days after exposure therapy
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 2 Feb 2016.
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.
Jasper Smits, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fear of Heights, run by University of Texas at Austin at 1 site in United States.
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 5 inclusion and 3 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 2 Feb 2016. 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 United States. 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?
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?
Fear scores (time frame: 7 (+/- 3) days after exposure therapy). 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?
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 2 Feb 2016.