Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001549213
Ethics application status
Approved
Date submitted
8/09/2018
Date registered
17/09/2018
Date last updated
17/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trials of the Rapid symptom shifting therapy
Scientific title
A trial of rapid symptom shift therapy compared with a control intervention for participants with significant anxiety.
Secondary ID [1] 296041 0
Nil
Universal Trial Number (UTN)
U1111-1213-9961
Trial acronym
TROSSMB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 309588 0
Condition category
Condition code
Mental Health 308408 308408 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the rapid symptom shift and will be part of a cross-over study. The intervention group will receive the Rapid Symptom Shift which is based on neurolinguistics programming concepts. The interviewer asks the patient if they can describe where their anxiety is in space. While this may seem an unusual request, patients often have no difficulty in explaining where it is located. They are asked to describe their anxiety in terms of colour and shape. In almost all cases they say it is close but has no shape and a variety of colours. Then they are asked to change the shape to a circle and put it in front of them. They are then asked what a “safe” colour for them is and to make the circle that colour. That image is then moved away visually and pushed to the horizon where it is stood up like a 50 cent piece. They are asked to then make it a 10 cent piece and put it face down so it is not visible. At this point they are asked how they feel about their “anxiety or stress’ and this visualisation from experience in the clinic almost always provides a positive response.The moving of the image to the horizon we think is the essential difference between the intervention and the control intervention. The mode of the interview delivery will be face to face on a one to one basis. It is done once only and lasts about 3 minutes. The interview will be conducted private clinics. The comparison condition is a visualisation of washing a car. This will not involve any attempt to move the visual object (the car) to the horizon. The sessions last about 3 minutes and they are done once only. This is a cross-over design and the interviewer will use the remote randomisation to choose the starting intervention. There is no washout period and the intervention. The interviewers will include a medical doctor, a counselor and therapists trained in neurolinguistic programming.

Intervention code [1] 312379 0
Behaviour
Comparator / control treatment
Comparator / control treatment; The comparator treatment for the cross-over trial will be the comparison condition of a visualisation of washing a car. This will not involve any attempt to move the visual object (the car) to the horizon. The sessions last about 3 minutes and they are done once only.
Control group
Active

Outcomes
Primary outcome [1] 307372 0
Anxiety scores on the state anxiety scale (STAI)
Timepoint [1] 307372 0
At the end of each cross-over arm
Primary outcome [2] 307373 0
Heart rate variability (this will be available at one centre only)
Timepoint [2] 307373 0
At the end of each arm in the cross over trial.
Secondary outcome [1] 351684 0
Emotional quality of life on a zero to 100 scale where 100 equals perfect emotional health and zero the worst possible.
Timepoint [1] 351684 0
At the end of each arm in the cross over trial

Eligibility
Key inclusion criteria
Adults who score State trait anxiety score > 39
Able to read and write English and understand the information sheet.
Age 16 to 80
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comprehend the information sheet and the consent form and <1 6yrs old.

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)
By remote computer on website caseweaver.co.nz
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use caseweaver.co.nz which is software that allows for blinded
and concealed randomisation once the baseline data has been entered. Patients are randomised to the control group or treatment arm(s) by
way of the standard built-in random number generator on the server.
This produces a random number between zero (assignment to the
control group) and the number of treatment arms (assignment to the
intervention 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


Intervention assignment
Crossover
Other design features
The study is a crossover design so all participants will get both the intervention and the control intervention. The participants will be told in the information sheet that they will only know the order of which they got at the end of the study and it may not be obvious what the difference between the intervention and control group is. The interviewer will administer the outcome questionnaires. To ensure an authentic and valid outcome participants will be required to answer a question stating that there was no interference with answering the questionnaire on the part of the interviewer.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be done by intention to treat analysis. The cross-over trial will use a paired t-test to analyse the results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2018
Actual
Date of last participant enrolment
Anticipated
25/11/2019
Actual
Date of last data collection
Anticipated
23/12/2019
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 20833 0
New Zealand
State/province [1] 20833 0
auckland

Funding & Sponsors
Funding source category [1] 300630 0
Charities/Societies/Foundations
Name [1] 300630 0
Royal New Zealand College of GPs Auckland Faculty Charitable Trust
Country [1] 300630 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Greenstone Family Clinic
Address
Address
PO BOx 75447
Manurewa
Auckland 2102
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300140 0
None
Name [1] 300140 0
Address [1] 300140 0
Country [1] 300140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301419 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 301419 0
Ethics committee country [1] 301419 0
New Zealand
Date submitted for ethics approval [1] 301419 0
25/07/2018
Approval date [1] 301419 0
22/08/2018
Ethics approval number [1] 301419 0
18/NTB/107

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86930 0
Prof Bruce Arroll
Address 86930 0
Department of General Practice
Univeristy of Auckland
Private Bag
92109
Auckland 1142
Country 86930 0
New Zealand
Phone 86930 0
+64 21378180
Fax 86930 0
+64 3737624
Email 86930 0
bruce.arroll@auckland.ac.nz
Contact person for public queries
Name 86931 0
Bruce Arroll
Address 86931 0
Department of General Practice
Univeristy of Auckland
Private Bag
92109
Auckland 1142
Country 86931 0
New Zealand
Phone 86931 0
+64 21378180
Fax 86931 0
+64 3737624
Email 86931 0
bruce.arroll@auckland.ac.nz
Contact person for scientific queries
Name 86932 0
Bruce Arroll
Address 86932 0
Department of General Practice
Univeristy of Auckland
Private Bag
92109
Auckland 1142
Country 86932 0
New Zealand
Phone 86932 0
+64 21378180
Fax 86932 0
+64 3737624
Email 86932 0
bruce.arroll@auckland.ac.nz

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.