Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001994279
Ethics application status
Approved
Date submitted
7/12/2018
Date registered
12/12/2018
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of the Rapid symptom shifting therapy - part 2
Scientific title
A trial of rapid symptom shift therapy compared with an inactive control intervention for participants with significant anxiety.
Secondary ID [1] 296826 0
None
Universal Trial Number (UTN)
U1111-1225-1924
Trial acronym
TROSSMB2
Linked study record
This study examines the same symptom shift intervention in the TROSSMB, (i.e. ACTRN12618001549213). While the intervention is the same the control intervention is TROSSMB2 is for the participant to just sit for 3 minutes doing nothing. Thus the control for this intervention is inactive. The study design is different as it involves a parallel design RCT as opposed to a cross-over trial in the TROSSMB trial.

Health condition
Health condition(s) or problem(s) studied:
anxiety 310724 0
Condition category
Condition code
Mental Health 309418 309418 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be the rapid symptom shift. 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 just sitting doing nothing. This sessions will last 3 minutes and they are done once only. The interviewer will use the remote randomisation to choose the intervention or the comparison intervention. The interviewers will include a medical doctor, a counsellor and therapists trained in neurolinguistic programming.
Intervention code [1] 313111 0
Treatment: Other
Comparator / control treatment
The comparator treatment will be sitting quietly for 3 minutes quietly and done once only.
Control group
Active

Outcomes
Primary outcome [1] 308365 0
Emotional quality of life on a zero to 100 scale where 100 equals perfect emotional health and zero the worst possible.
Timepoint [1] 308365 0
At the end of the intervention at about 3 minutes from the start.
Primary outcome [2] 308366 0
STAI state anxiety score
Timepoint [2] 308366 0
At the end of the intervention at about 3 minutes from the start.
Secondary outcome [1] 354759 0
Heart rate variability {HRV} (this will be available at one centre only where there is a heart math machine capable of measuring HRV ).
Timepoint [1] 354759 0
At the end of the intervention at about 3 minutes from the start.

Eligibility
Key inclusion criteria
Able to read and write English and understand the information sheet.
Age 16 to 80
Gender
Both males and females

STAI (state anxiety score) of greater than or equal to 35
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Key exclusion criteria
Unable to comprehend the information sheet and the consent form

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
participants will be asked to sign a sheet saying that the interviewer has not directed them to answer any particular score on the study questionnaires.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be done by intention to treat analysis using t-test to analyse the results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
24/12/2019
Actual
Date of last data collection
Anticipated
24/12/2019
Actual
Sample size
Target
127
Accrual to date
Final
Recruitment outside Australia
Country [1] 21111 0
New Zealand
State/province [1] 21111 0

Funding & Sponsors
Funding source category [1] 301398 0
Charities/Societies/Foundations
Name [1] 301398 0
Oakley Mental Health Research Foundation
Country [1] 301398 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 301074 0
University
Name [1] 301074 0
University of Auckland
Address [1] 301074 0
Private Bag 92019
Auckland 1142
Country [1] 301074 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302135 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 302135 0
Ethics committee country [1] 302135 0
New Zealand
Date submitted for ethics approval [1] 302135 0
25/07/2016
Approval date [1] 302135 0
22/08/2018
Ethics approval number [1] 302135 0
18/NTB/107

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

Contacts
Principal investigator
Name 89242 0
Prof Bruce Arroll
Address 89242 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 89242 0
New Zealand
Phone 89242 0
+64 9236978
Fax 89242 0
+64 93737624
Email 89242 0
[email protected]
Contact person for public queries
Name 89243 0
Bruce Arroll
Address 89243 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 89243 0
New Zealand
Phone 89243 0
+64
Fax 89243 0
+64 9 3737624
Email 89243 0
[email protected]
Contact person for scientific queries
Name 89244 0
Bruce Arroll
Address 89244 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 89244 0
New Zealand
Phone 89244 0
+64 9236978
Fax 89244 0
+64 9 3737624
Email 89244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all data can be shared except participant names
When will data be available (start and end dates)?
24/12/2018 to 24/12/2029
Available to whom?
to anyone who requests
Available for what types of analyses?
For any type of analysis
How or where can data be obtained?
in a spreadsheet


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.