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Trial registered on ANZCTR
Registration number
ACTRN12614000530628
Ethics application status
Not yet submitted
Date submitted
16/02/2014
Date registered
20/05/2014
Date last updated
20/05/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomized controlled trial of a Neuro-linguistic Programming technique (Phobia Cure) for people with a fear of heights.
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Scientific title
In people with a fear of heights does the Neurolinguistic Programming technique (Phobia Cure) compared with a control activity reduce the fear of heights on the Heights Interpretation Questionnaire (HIQ) at 8 weeks.
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Secondary ID [1]
284525
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None
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Universal Trial Number (UTN)
U1111-1153-4383
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Trial acronym
NeuroLPC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fear of Heights (score > 29 on the Heights Interpretation Questionnaire)
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Anxiety
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Condition category
Condition code
Mental Health
291519
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Both the intervention group and the control group will get a neurolinguistic programming relaxation activity (known as the relaxation anchor). The technique asks the participant to think of a favourite place. They are asked to close their eyes and imagine what the place looks like, sounds like, feels like, smells like and tastes like. They are asked to repeat the experience and when they get to the change from seeing to hearing they are asked to touch their thumb to their index finger. They repeat this twice. Then they are asked to touch their thumb to their index finger and see if they can get back that pleasant sensation. This is known as a relaxation anchor. In addition the intervention group will get the the Phobia cure. This will be done by clinicians who will be trained in the technique. This requires the patient to relive an experience of when they were exposed to a height and felt stressful. They are asked to make a movie of that experience in their head and to imagine they are watching the movie from a seat in the theatre and that they are watching themselves watching the movie from the projection box. They run the movie forward in real time but in black and white and far away. Once they get to the end they are asked to float up in to the screen and be in the movie. They then run it backwards, in colour, as fast as possible such that their voice sounds like Donald Duck and their arms are waving in the air. They are asked to pop out the end from where they started the movie. They are asked how they feel about heights and if they feel better. The intervention can stopped there but up to three cycles may be needed to be certain that a change has occurred. Each therapy session will last about 30 minutes and after 3 cycles have been administered there will be no more cycles on that day or there after. There is a moment called a "break state" when the participant is asked to look out a window (to clear their thoughts). Between each cycle.
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Intervention code [1]
288799
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Treatment: Other
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Intervention code [2]
288800
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Behaviour
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Comparator / control treatment
The control intervention willget the same NLP relaxation technigue (the anchor)as the intervention group in addition to a 20 minute meditation MP3 by Vidayamala to match the time spent doing the Phobia cure in the intervention group. This is to avoid a time co-intervention bias in the intervention group. As both group get the anchor the study is a comparison of the phobia cure versus a one time meditation MP3.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in average scores on the HIQ continuous outcomes between intervention and control.
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Assessment method [1]
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Timepoint [1]
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Eight weeks after the intervention
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Secondary outcome [1]
306889
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Five step outcome. completely gone, much less bothersome, no change, much more bothersome, fully present between intervention and control.
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Assessment method [1]
306889
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Timepoint [1]
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Eight weeks from intervention
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Secondary outcome [2]
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Self assessment of fear of heights on scale of 1 to 10 with 10 being very fearful of heights between intervention and control.
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Assessment method [2]
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Timepoint [2]
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Eight weeks after the intervention
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Secondary outcome [3]
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Mean difference on the GAD 7 general anxiety disorder questionnaire between intervention and control.
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Assessment method [3]
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Timepoint [3]
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8 weeks
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Eligibility
Key inclusion criteria
HIQ score > 29
Able to read and write English
Healthy volunteers
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Intoxication, dementia and terminal illness.
2. Psychotic disorder.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Remote computer (Server name is - caseweaver.com)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are randomised to the control group or treatment arm by way of the standard built-in random number generator on the server. This produces a random number of zero (assignment to the control group) or one (assignment the treatment arm). Each time the application launches, the random number generator is initialized with a random value, which is obtained from the system clock.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
If participants are completing their outcome forms in person the participants will be asked to sign a validation form to say they have not had any assistance from the interviewer in completing the forms. Where possible the outcome forms will be emailed or posted back to the trial.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The analysis will use a chi-squared analysis on the outcome measures and be controlled for any baseline differences. Participants withdrawing from the study will be encouraged to attend follow-up visits and their data included in an intention-to-treat analysis. The sample size is based on a 30% effect size from 60% residual fear of heights to a 30% fear of heights with an alpha of 0.05 and a beta of 0.2.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
24/05/2014
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Actual
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Date of last participant enrolment
Anticipated
31/12/2015
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
96
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5828
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New Zealand
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State/province [1]
5828
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Funding & Sponsors
Funding source category [1]
288738
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Charities/Societies/Foundations
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Name [1]
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Oakley Mental Health Research Foundation
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Address [1]
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Level 2, Building 505, 85 Park Road, Grafton, Auckland
Private Bag 92019
Auckland 1142
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Country [1]
288738
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Private Bag 92019
Auckland 1142
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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Oakley Mental Health Research Foundation
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Address [1]
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Level 2, Building 505, 85 Park Road, Grafton, Auckland
Private Bag 92019
Auckland 1142
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Country [1]
287434
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New Zealand
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Health and Disability Ethics Commitee
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Ethics committee address [1]
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No 1 The Terrace
PO Box 5013
Wellington
6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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15/02/2014
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Approval date [1]
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Ethics approval number [1]
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14/NTA/23
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Summary
Brief summary
Anxiety disorders are the most common mental disorder in the developed world. Phobias are an anxiety disorder and are common in our community. The prevalence in general practice is approximately 13% (35.7% of patients in primary care have mental disorders). The morbidity associated with this has not been adequately quantified but anecdotally it can affect patient health care with a needle phobia interfering with blood testing and claustrophobia with an MRI scan. We plan to use the “Phobia Cure” to determine if it is effective in those with a fear of heights.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Bruce Arroll
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Address
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Department of General Practice and Primary Health Care
University of Auckland
Physical Address
Tamaki Campus
261 Morrin Road
Glen Innes
1072
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Country
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New Zealand
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Phone
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64-9-9236978
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Fax
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64-9-3737624
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Email
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[email protected]
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Contact person for public queries
Name
46295
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Prof Bruce Arroll
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Address
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Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Physical Address
Tamaki Campus
261 Morrin Road
Glen Innes
1072
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Country
46295
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New Zealand
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Phone
46295
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64-9-9236978
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Fax
46295
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64-9-3737624
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Email
46295
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[email protected]
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Contact person for scientific queries
Name
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Prof Bruce Arroll
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Address
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Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Physical Address
Tamaki Campus
261 Morrin Road
Glen Innes
1072
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Country
46296
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New Zealand
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Phone
46296
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64-9-9236978
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Fax
46296
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64-9-3737624
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Email
46296
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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