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Trial registered on ANZCTR


Registration number
ACTRN12618001634268
Ethics application status
Approved
Date submitted
26/09/2018
Date registered
3/10/2018
Date last updated
3/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trials of the effect of mBrain therapy with people with significant anxiety at 4 weeks after the intervention.
Scientific title
A trial of mBrain therapy compared with a control intervention for participants with significant anxiety with a follow up at 4 weeks
Secondary ID [1] 296178 0
Nil
Universal Trial Number (UTN)

U1111-1221-1064
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 309805 0
Condition category
Condition code
Mental Health 308600 308600 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is anticipated that the mBrain Process will be around 30 to 40 minutes. The intervention is done on an individual face to face basis by one therapist. There will be two therapists doing the intervention who are trained in mBrain work. It is a talk therapy. The time in each stage is about half so 15 to 20 minutes in stage 1 and stage 2. The two therapists are located at 6 Rangiwai Rd, Titirangi, a suburb in west Auckland.
Stage 1 – Autonomic Balance
Participants will be taught how to use a balanced breathing regime to regulate their autonomic nervous system. This will be guided by a script, but through observation of the participant may require some individualisation to ensure compliance.

Stage 2 mBrain Meditation
A scripted mBrain Meditation (which will be recorded for consistency) will be played for each participant, with sufficient space for internal processing and accessing of head, heart and gut intelligence.

The therapists who administer the therapies are trained in alternative therapies of which mBrain therapy would be considered.
Intervention code [1] 312506 0
Treatment: Other
Comparator / control treatment
A basic mindfulness meditation which still focuses on breathing, but does not intervene with breathing rhythm. This will take the approximately the same length of time as the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 307565 0
STAI State anxiety inventory
Timepoint [1] 307565 0
At the end of the intervention/control and at 4 weeks after randomisation
Primary outcome [2] 307566 0
Heart rrate variability (HRV) as measured by Heart math HRV machine
Timepoint [2] 307566 0
This will be done at the end of first visit once the intervention or control intervention has been applied.
Primary outcome [3] 307567 0
Emotional quality of life score with 100 being perfect emotional health and 0 being worst imaginable.
Timepoint [3] 307567 0
At the end of the intervention/control and at 4 weeks after randomisation
Secondary outcome [1] 352302 0
STAI dichotomous outcome of those with < 40 score
Timepoint [1] 352302 0
At 4 weeks after randomisation
Secondary outcome [2] 352303 0
GAD-7 scale
Timepoint [2] 352303 0
4 weeks after randomisation

Eligibility
Key inclusion criteria
Adults 16 years of age and over up to 80 years old
Able to read and write English and understand the information sheet
Significant anxiety with an STAI score of > 39
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comprehend information sheet and outside the age range

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)
Once enrolled a treatment code will be obtained from www.caseweaver.co.nz
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization will be carried out using the Caseweaver.co.nz controlled trials package which enables concealed randomization to occur.
a. Patients are randomised to the control group or intervention 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.
b. Patients are identified by way of a study identifier.
c. When a patient is enrolled into the trial, they are randomly assigned to either the control arm or the intervention arm. This is recorded on the server, made visible to the investigator, and used with subsequent data entries.
d. When data are sent to the server, they are encrypted prior to saving in the database, and decrypted on demand when it is required for display or reporting. This means that all the trial data in the database are encrypted. Access to the data is restricted to the investigator or other users to which the investigator has explicitly delegated access privileges (such as a research assistant). User passwords are also stored encrypted in the database, plus additional measures are applied to ensure that it is impossible to deduce someone's password from the database.
e. For additional security, access is restricted by requiring that each user has a "client certificate" installed on their computer, in addition to having their username and password. This is referred to as "two factor authentication".
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants will sign a certificate of validation at the end of the intervention (as there are some outcomes measured at the end of the first visit) to state that the interviewer did not do anything to influence their filling out of the questionnaires.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will done by intention to treat analysis. For the categorical outcomes expressed using counts (percentages) and compared between treatment groups using the Chi squared test. Continuous variables will be expressed using mean (standard deviation) and compared between groups using an analysis of variance. 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 4 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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/10/2018
Actual
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
20/01/2020
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment outside Australia
Country [1] 20869 0
New Zealand
State/province [1] 20869 0
auckland

Funding & Sponsors
Funding source category [1] 300768 0
Charities/Societies/Foundations
Name [1] 300768 0
Oakley Mental Health Research Foundation
Country [1] 300768 0
New Zealand
Primary sponsor type
Individual
Name
Professor Bruce Arroll
Address
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 300345 0
None
Name [1] 300345 0
Address [1] 300345 0
Country [1] 300345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301551 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 301551 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 301551 0
New Zealand
Date submitted for ethics approval [1] 301551 0
02/05/2018
Approval date [1] 301551 0
22/08/2018
Ethics approval number [1] 301551 0

Summary
Brief summary
This trial plans to study an intervention called mBrain therapy to evaluate if it is more effective than a mindfulness control activity for people with significant anxiety. As a new field mBraining is showing some encouraging results but at present lacks a robust empirical base to show unequivocally that it works in practice. Stress and Anxiety is one area where mBraining is having encouraging results and it is for that reason that we believe it would be valuable to evaluate mBraining in this study to demonstrate the impact that can be experienced through teaching new behavioural patterns which lead to the balancing of the autonomic nervous system. The intervention is a basic physiological taught technique to reduce the sympathetic response caused by stress and anxiety. It is our belief that the impact from the foundational mBIT Processes would be more significant and longer lasting.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87354 0
Prof Bruce Arroll
Address 87354 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 87354 0
New Zealand
Phone 87354 0
+64 21378180
Fax 87354 0
+64 3737624
Email 87354 0
[email protected]
Contact person for public queries
Name 87355 0
Bruce Arroll
Address 87355 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 87355 0
New Zealand
Phone 87355 0
+64 21378180
Fax 87355 0
+64 3737624
Email 87355 0
[email protected]
Contact person for scientific queries
Name 87356 0
Bruce Arroll
Address 87356 0
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
Country 87356 0
New Zealand
Phone 87356 0
+64 21378180
Fax 87356 0
+64 3737624
Email 87356 0
[email protected]

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.