Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001346460
Ethics application status
Approved
Date submitted
5/09/2016
Date registered
27/09/2016
Date last updated
13/08/2019
Date data sharing statement initially provided
13/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of the rapid symptom shifting therapy for anxiety
Scientific title
A randomized controlled trial of the Rapid symptom shifting technique (a form on imaginal therapy) for people with significant anxiety versus a control imaginal therapy using an anxiety inventory score (STAI) as an outcome..
Secondary ID [1] 290061 0
Nil
Universal Trial Number (UTN)
U1111-1179-1166
Trial acronym
RASST (Rapid Symptom Shift Technique)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 300192 0
Condition category
Condition code
Mental Health 300075 300075 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the Rapid Symptom Shift. The interviewer (a GP with 30 years experience, a masters student with research training and a alternative therapy practitioner with 20 years experience) 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. We plan to measure this response with changes in the STAI questionnaire and the participant’s heart rate variability. 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 in University consulting rooms or private clinics.
Intervention code [1] 295844 0
Treatment: Other
Comparator / control treatment
The control condition will be 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] 299545 0
The primary outcome of the trial is to measure any statistically significant change to the participants anxiety scores on the state trait anxiety scale immediately after the intervention, and at 8 weeks after the intervention.
Timepoint [1] 299545 0
Immediately after the intervention
Primary outcome [2] 299546 0
Heart rate variability as measured by a chest lead sending a signal to a Polar watch.
Timepoint [2] 299546 0
Immediately after the intervention
Secondary outcome [1] 327489 0
STAI questionnaire
Timepoint [1] 327489 0
8 weeks after the intervention
Secondary outcome [2] 327490 0
HAD-s Hospital anxiety and depression scale
Timepoint [2] 327490 0
8 weeks after the intervention.

Eligibility
Key inclusion criteria
Otherwise healthy volunteers with significant anxiety
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to understand the information sheet.

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)
Via remote server www.caseweaver.co.nz)
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 between zero (assignment to the control group) and the treatment arm (assignment to one of the treatment arm or control). 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
Intervention assignment
Parallel
Other design features
There will be a validation certificate asking participants to state that the interviewers have not implied that the intervention they got was better than the one they did not and that there was no influence on how they answered the questionnaire.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will done by intention to treat analysis. Categorical outcomes were expressed using counts (percentages) and compared between treatment groups using the Chi squared test. Continuous variables were expressed using mean (standard deviation) and compared between groups using an analysis of variance. The secondary outcome of GAD is expressed in medians and compared between groups using the Mann-Whitney U test. The multivariate models for the dichotomous outcomes will be evaluated using logistic regression to calculate odds ratios (which will be converted to risk ratios using the formula of Zhang), with confidence intervals. The continuous outcomes will be analysed using multiple linear regression. All multivariate models controlled for age and gender (and the baseline level of STAI for the primary outcome of STAI). Missing data at 8 weeks will be imputed. A two-tailed p value< 0.05 was considered to be significant. Statistical analysis was performed using SAS V.9.3 (SAS Institute Inc., Cary, North Carolina, USA).

The sample size: based on a difference of 7 points from a baseline of 45 (SD 13.5) on the STAI states scale and will require -58 in the intervention and 58 in the control group (two sided alpha =0.05, beta = 0.2) Total n= 116. We will recruit 130 participants to allow for 14 dropouts.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/10/2016
Actual
5/10/2016
Date of last participant enrolment
Anticipated
29/12/2017
Actual
29/12/2017
Date of last data collection
Anticipated
23/02/2018
Actual
23/02/2018
Sample size
Target
130
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 8203 0
New Zealand
State/province [1] 8203 0
Auckland

Funding & Sponsors
Funding source category [1] 294470 0
Charities/Societies/Foundations
Name [1] 294470 0
Oakley Mental Health Research Foundation
Country [1] 294470 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293447 0
None
Name [1] 293447 0
Address [1] 293447 0
Country [1] 293447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295975 0
Health and Disability Ethics Committees
Ethics committee address [1] 295975 0
Ethics committee country [1] 295975 0
New Zealand
Date submitted for ethics approval [1] 295975 0
Approval date [1] 295975 0
20/09/2016
Ethics approval number [1] 295975 0
16/NTB/140

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

Contacts
Principal investigator
Name 68722 0
Prof Bruce Arroll
Address 68722 0
Elaine Gurr Chair of General Practice and Primary Health Care
Director of the Goodfellow Unit
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
New Zealand
Country 68722 0
New Zealand
Phone 68722 0
+64 9-9236978
Fax 68722 0
+64-3737624
Email 68722 0
[email protected]
Contact person for public queries
Name 68723 0
Bruce Arroll
Address 68723 0
Elaine Gurr Chair of General Practice and Primary Health Care
Director of the Goodfellow Unit
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
New Zealand
Country 68723 0
New Zealand
Phone 68723 0
+64 9-9236978
Fax 68723 0
+64-3737624
Email 68723 0
[email protected]
Contact person for scientific queries
Name 68724 0
Bruce Arroll
Address 68724 0
Director of the Goodfellow Unit
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
New Zealand
Country 68724 0
New Zealand
Phone 68724 0
+64 9-9236978
Fax 68724 0
+64-3737624
Email 68724 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 collected except patient names
When will data be available (start and end dates)?
1/5/2019 to indefinite
Available to whom?
to whomever makes the case
Available for what types of analyses?
any analysis
How or where can data be obtained?
email


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.