Phobic DisordersPhase 2/3NCT02007694

Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

A Phase 2/3 study testing Virtual Reality Exposure Therapy (VRET) in people with Phobic Disorders, run by VU University of Amsterdam at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Phobic Disorders
What is being tested?: Virtual Reality Exposure Therapy (VRET)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteNetherlands
Study dates: Mar 2013to Dec 2014
Phase: Phase 2/3
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures.
Being older than 18 years and younger than 75 years.

Who cannot join

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University of Amsterdam
Amsterdam, North Holland, 1018XA

Other trials in Netherlands

About this study

Recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine hydrochloride (YOH). A finding in animal literature is that the administration of YOH during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. It is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine. However, recent findings demonstrate mixed results. In a randomized controlled trial claustrophobic participants underwent exposure in combination with YOH or placebo. The YOH group showed significantly better results on anxiety improvement than the placebo group. In a more recent study with participants with fear of flying no additional benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies by enhancing the dose of YOH in combination with VRET and by extending our experimental design with another group which receives propranolol in combination with VRET. Propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy humans. In this randomized controlled trial a between groups design is chosen to further characterize the differential within and between trial extinction and to enhance possible between groups effects. Sixty participants with fear of flying or fear of heights will be randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three sessions of VRET over a period of two weeks.

Conditions: Phobic Disorders
Being tested: Virtual Reality Exposure Therapy (VRET)
Keywords: Phobic Disorders (Fear of Flying and acrophobia), Virtual Reality Exposure Therapy, Fear extinction, propranolol, Yohimbine
Medical subject headings: Phobic Disorders, Aerophobia, Acrophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Exposure Therapy (VRET)Behavioural
Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

Study groups in NCT02007694
Study group	Role	What they receive
VRET plus Yohimbine	Active comparator	Virtual Reality Exposure Therapy combined with the administration of yohimbine. Receives: Behavioral: Virtual Reality Exposure Therapy (VRET)
VRET plus propranolol	Active comparator	Virtual Reality Exposure Therapy combined with the administration of propranolol Receives: Behavioral: Virtual Reality Exposure Therapy (VRET)
VRET plus placebo	Placebo comparator	Virtual Reality Exposure Therapy combined with the administration of a non-active placebo pill Receives: Behavioral: Virtual Reality Exposure Therapy (VRET)

What is being measured

The primary outcome is the main question the study is designed to answer.

FAS (Flight Anxiety Situations Questionnaire)
The FAS is 32-item, self-report inventory designed to measure anxiety related to flying experienced in different situations. The FAS is divided into three subscales: the Anticipation scale, which represents situations before the actual flight, the In-flight scale, which refers to situations during a flight and the Generalized flight scale.
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
AQ (Acrophobia Questionnaire)
The AQ (Cohen, 1977) is a 40-item self-report measure to assess anxiety in height situations. The AQ measures anxiety and avoidance behavior relative to height situations. Subject can express their fear on a scale ranging from 0-6, whereby 0 stands for "no fear at all" and 6 for "almost panic" (ranging from 0-120).
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
WAQ (Weekly Anxiety Questionnaire)
The WAQ is an author-constructed transdiagnostic anxiety questionnaire to rate severity of experienced general anxiety. The WAQ is a 10-item self-report measure on which participants can rate their experienced anxieties. Ratings can be scored on a five-point Likert scale ranging from "not at all" to "permanently".
Measured: In session 1, 2 and 3 and Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)

Secondary outcomes (6)

FAM (Flight Anxiety Modalities Questionnaire)
The FAM is 23-item, self-report inventory designed to measure how fear of flying can be expressed. On a five-point-likert scale the intensity of fear can be rated. The FAM is divided into two subscales: the Somatic Modality, which represents the physical symptoms and the Cognitive Modality, which measures distressing cognitions.
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
ATHQ (Attitude towards heights questionnaire)
The ATHQ contains six questions assessing the attitude towards heights (range 0-60).
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
DASS (Depression Anxiety Stress Scale)
The DASS is 42-item self-report measure that assesses level of depression, anxiety, and stress over the previous week. Each scale consists of 14 items, which are grouped into smaller subscales. The depression scale consists of the following subscales: dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia and inertia. The anxiety scale consists of: autonomic arousal, skeletal musculature effects, situational anxiety and subjective experience of anxious affect. The stress scale consists of: difficulty relaxing, nervous arousal, easily agitated, irritable/overreactive and impatient. The internal consistency of the DASs is good to excellent (Cronbach's alpha ranging from .88 to .96; Brown et al., 1997).
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
PIT (Prospective Imagery Task)
The PIT is based on MacLeod and Byrne, (1996) and Stöber, (2000) and will be used to measure imagery for 10 positive and 10 negative prospective events. As in Holmes, Lang, et al. (2008), subjects will be asked to rate the vividness of prospective positive events (e.g., "You will have lots of energy and enthusiasm") or negative events (e.g., "Someone close to you will reject you") on a 5-point scale (1 = no image at all; 5 = very vivid).
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
ASI (Anxiety Sensitivity Inventory)
The ASI is a 16-items self-report questionnaire, measuring fear of anxiety-related symptoms. Each item is rated on a five-point likert scale ranging from 0 (very little) to 4 (very much). The ASI is scored by summing all items; possible scores range from 0 to 64, with higher scores reflecting higher levels of anxiety sensitivity.
Measured: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
SUDs (Subjective Units of Discomfort)
Subjective Units of Discomfort (SUDs) will be taken every 3 minutes to monitor patients' subjective anxiety (Wolpe, 1990).
Measured: Every 3 minutes during exposure (exposure will be done twicely 25 minutes every therapy session. Thus, starting at minute 1 every 3 minute a SUD will be asked. After a break of 10 minutes, exposure will start again (25 minutes).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Dec 2014

First posted11 Dec 2013 (estimated)
Study startMar 2013
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Phobic DisordersStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02007694
Sponsor's protocol ID: 2012-KP-2464
Status last verified: Jul 2015
First submitted: 20 Mar 2013
Last updated: 8 Jul 2015
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants
ClinicalTrials.gov ID: NCT02007694
Acronym / sponsor ID: 2012-KP-2464
Conditions: Phobic Disorders
Keywords: Phobic Disorders (Fear of Flying and acrophobia), Virtual Reality Exposure Therapy, Fear extinction, propranolol, Yohimbine
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: VU University of AmsterdamUniversity, hospital or other
Study start: Mar 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 11 Dec 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
VRET plus Yohimbine	Active comparator	Behavioral: Virtual Reality Exposure Therapy (VRET)Virtual Reality Exposure Therapy combined with the administration of yohimbine.
VRET plus propranolol	Active comparator	Behavioral: Virtual Reality Exposure Therapy (VRET)Virtual Reality Exposure Therapy combined with the administration of propranolol
VRET plus placebo	Placebo comparator	Behavioral: Virtual Reality Exposure Therapy (VRET)Virtual Reality Exposure Therapy combined with the administration of a non-active placebo pill

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures.
Being older than 18 years and younger than 75 years.

Key exclusion criteria (1 listed)

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
Virtual Reality Exposure Therapy (VRET)Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.	Behavioural	VRET plus Yohimbine, VRET plus placebo, VRET plus propranolol

Primary outcome

FAS (Flight Anxiety Situations Questionnaire)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
The FAS is 32-item, self-report inventory designed to measure anxiety related to flying experienced in different situations. The FAS is divided into three subscales: the Anticipation scale, which represents situations before the actual flight, the In-flight scale, which refers to situations during a flight and the Generalized flight scale.
AQ (Acrophobia Questionnaire)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
The AQ (Cohen, 1977) is a 40-item self-report measure to assess anxiety in height situations. The AQ measures anxiety and avoidance behavior relative to height situations. Subject can express their fear on a scale ranging from 0-6, whereby 0 stands for "no fear at all" and 6 for "almost panic" (ranging from 0-120).
WAQ (Weekly Anxiety Questionnaire)
Time frame: In session 1, 2 and 3 and Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
The WAQ is an author-constructed transdiagnostic anxiety questionnaire to rate severity of experienced general anxiety. The WAQ is a 10-item self-report measure on which participants can rate their experienced anxieties. Ratings can be scored on a five-point Likert scale ranging from "not at all" to "permanently".

6 secondary outcomes

FAM (Flight Anxiety Modalities Questionnaire)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
ATHQ (Attitude towards heights questionnaire)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
DASS (Depression Anxiety Stress Scale)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
PIT (Prospective Imagery Task)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
ASI (Anxiety Sensitivity Inventory)
Time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)
SUDs (Subjective Units of Discomfort)
Time frame: Every 3 minutes during exposure (exposure will be done twicely 25 minutes every therapy session. Thus, starting at minute 1 every 3 minute a SUD will be asked. After a break of 10 minutes, exposure will start again (25 minutes).

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 8 Jul 2015.

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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.

Paul Emmelkamp, PhD principal investigator

University of Amsterdam

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Virtual Reality Exposure Therapy (VRET) in people with Phobic Disorders, run by VU University of Amsterdam at 1 site in Netherlands.

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 8 Jul 2015. 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 Netherlands. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

FAS (Flight Anxiety Situations Questionnaire) (time frame: Pre- (baseline) and post-assessment (after treatment termination, within 3 weeks after first treatment session) and 3 month follow up (3 month after post assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02007694.

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 8 Jul 2015.