Trial Review

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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.
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.
Secondary ID [1] 284525 0
None
Universal Trial Number (UTN)
U1111-1153-4383
Trial acronym
NeuroLPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fear of Heights (score > 29 on the Heights Interpretation Questionnaire) 291181 0
Anxiety 291182 0
Condition category
Condition code
Mental Health 291519 291519 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288799 0
Treatment: Other
Intervention code [2] 288800 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 291489 0
Change in average scores on the HIQ continuous outcomes between intervention and control.
Timepoint [1] 291489 0
Eight weeks after the intervention
Secondary outcome [1] 306889 0
Five step outcome. completely gone, much less bothersome, no change, much more bothersome, fully present between intervention and control.
Timepoint [1] 306889 0
Eight weeks from intervention
Secondary outcome [2] 306890 0
Self assessment of fear of heights on scale of 1 to 10 with 10 being very fearful of heights between intervention and control.
Timepoint [2] 306890 0
Eight weeks after the intervention
Secondary outcome [3] 308022 0
Mean difference on the GAD 7 general anxiety disorder questionnaire between intervention and control.
Timepoint [3] 308022 0
8 weeks

Eligibility
Key inclusion criteria
HIQ score > 29
Able to read and write English
Healthy volunteers
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Intoxication, dementia and terminal illness.
2. Psychotic disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Remote computer (Server name is - caseweaver.com)
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/05/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 5828 0
New Zealand
State/province [1] 5828 0

Funding & Sponsors
Funding source category [1] 288738 0
Charities/Societies/Foundations
Name [1] 288738 0
Oakley Mental Health Research Foundation
Country [1] 288738 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287434 0
Charities/Societies/Foundations
Name [1] 287434 0
Oakley Mental Health Research Foundation
Address [1] 287434 0
Level 2, Building 505, 85 Park Road, Grafton, Auckland
Private Bag 92019
Auckland 1142
Country [1] 287434 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290572 0
Health and Disability Ethics Commitee
Ethics committee address [1] 290572 0
No 1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 290572 0
New Zealand
Date submitted for ethics approval [1] 290572 0
15/02/2014
Approval date [1] 290572 0
Ethics approval number [1] 290572 0
14/NTA/23

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46294 0
Prof Bruce Arroll
Address 46294 0
Department of General Practice and Primary Health Care
University of Auckland
Physical Address
Tamaki Campus
261 Morrin Road
Glen Innes
1072
Country 46294 0
New Zealand
Phone 46294 0
64-9-9236978
Fax 46294 0
64-9-3737624
Email 46294 0
bruce.arroll@auckland.ac.nz
Contact person for public queries
Name 46295 0
Prof Bruce Arroll
Address 46295 0
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
Country 46295 0
New Zealand
Phone 46295 0
64-9-9236978
Fax 46295 0
64-9-3737624
Email 46295 0
bruce.arroll@auckland.ac.nz
Contact person for scientific queries
Name 46296 0
Prof Bruce Arroll
Address 46296 0
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
Country 46296 0
New Zealand
Phone 46296 0
64-9-9236978
Fax 46296 0
64-9-3737624
Email 46296 0
bruce.arroll@auckland.ac.nz

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No Supporting Document Provided



Results publications and other study-related documents

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