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Trial registered on ANZCTR


Registration number
ACTRN12619000603112p
Ethics application status
Not yet submitted
Date submitted
1/02/2019
Date registered
18/04/2019
Date last updated
18/04/2019
Date data sharing statement initially provided
18/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility and efficacy cross over clinical trial of reinforcing subconscious re framing of past and present programs to reduce symptoms of Post Traumatic Stress Disorder (PTSD)
Scientific title
A feasibility and efficacy cross over clinical trial of reinforcing subconscious re framing of past and present programs to reduce symptoms of Post Traumatic Stress Disorder (PTSD)
Secondary ID [1] 297272 0
nil known
Universal Trial Number (UTN)
U1111-1227-8260
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder (PTSD) 311346 0
depression 311349 0
anxiety 311350 0
Condition category
Condition code
Mental Health 309983 309983 0 0
Other mental health disorders
Mental Health 311009 311009 0 0
Depression
Mental Health 311010 311010 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arms 1 and 2 of the study will be interviewed. Each will complete the PTSD questionnaire and Pass 21 to assess levels of PTSD, depression and anxiety. The interview will discover the inciting moment that PTSD occurred and also a positive future the participant would like to have. Following this a 10 minute meditation audio recording will be created, which reframes the inciting moment (when the event that caused the PTSD happened) of the PTSD and also creates their specific positive future for the individual.


The delivery and interview will be conduced by Dr Nick Krasner. This will be done as a one to one in a GP practice in Sydney.

Arm 1 will be sent a copy of the 10 minute individualised meditation audio. They are to listen to this twice a day for 8 weeks.

Arm 2 will be sent a 10 minute audio of Mozart music to listen to. They are to listen to this twice a day for 8 weeks.

During the 8 weeks both groups will tick that they have completed their tasks, twice a day in a participation diary.

The wash out period will be for 2 weeks and then

Arm 1 of the study will be sent a 10 minute audio of Mozart music to listen to. They are to listen to this twice a day for 8 weeks.

Arm 2 of the study will be sent a copy of the 10 minute individualised meditation audio. They are to listen to this twice a day for 8 weeks.

Intervention code [1] 313526 0
Treatment: Other
Comparator / control treatment
The interview will be done by Dr Nick Krasner GP
It's duration is approximately 1 hour
The music will be a relaxing exert from Mozart.
Control group
Active

Outcomes
Primary outcome [1] 318899 0
Change of symptoms of PTSD (using PTSD scoring from DSM V)
Timepoint [1] 318899 0
8 weeks
Primary outcome [2] 318900 0
Change of symptoms of anxiety (using Dass 21)
Timepoint [2] 318900 0
8 weeks
Primary outcome [3] 318901 0
Change of symptoms of depression (using Dass 21)
Timepoint [3] 318901 0
8 weeks
Secondary outcome [1] 366544 0
Change of symptoms of PTSD (using PTSD scoring from DSM V )
Timepoint [1] 366544 0
18 weeks (8 weeks then 2 weeks washout followed by 8 weeks)
Secondary outcome [2] 366545 0
Change of symptoms of anxiety (using Dass 21)
Timepoint [2] 366545 0
18 weeks (8 weeks then 2 weeks washout followed by 8 weeks)
Secondary outcome [3] 366546 0
Change of symptoms of depression (using Dass 21)
Timepoint [3] 366546 0
Change of symptoms of anxiety (using Dass 21)

Eligibility
Key inclusion criteria
Participants, regardless of gender, at least 18 years of age and diagnosed with Post Traumatic
Stress Disorder (PTSD) based on the DSM V criteria for PTSD. (https://drive.google.com/file/d/11FgTlgMQmZGx_UYiYciABvIHI_k2svwm/view?usp=sharing.) Participants were also required to have a
sufficient level of education to understand study procedures and be able to communicate with site
personnel.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who are not clinically diagnosed with PTSD as per DSM V guidelines.
Severe hearing impediment
Those who do not have the mental capicity to be fully consented in the study.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) to recieve first either the audio recording for their PTSD or an audio with Mozart.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
paired pre and post paired t test - ranking test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301832 0
Self funded/Unfunded
Name [1] 301832 0
dr nick krasner
Country [1] 301832 0
Australia
Primary sponsor type
University
Name
notre dame university sydney
Address

160 Oxford St
Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 302050 0
None
Name [1] 302050 0
Address [1] 302050 0
Country [1] 302050 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302534 0
The University of Notre Dame Australia Human Research Ethics Committee., The University of Notre Dame Australia, Fremantle
Ethics committee address [1] 302534 0
Ethics committee country [1] 302534 0
Australia
Date submitted for ethics approval [1] 302534 0
03/05/2019
Approval date [1] 302534 0
Ethics approval number [1] 302534 0

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

Contacts
Principal investigator
Name 90554 0
A/Prof Charlotte Hespe
Address 90554 0
Head, General Practice and Primary Care Research

School of Medicine, Sydney

The University of Notre Dame Australia

160 Oxford St, Darlinghurst, NSW 2010

PO Box 944 Broadway, NSW 2007
Country 90554 0
Australia
Phone 90554 0
+61 02 8204 4461
Fax 90554 0
Email 90554 0
charlotte.hespe@nd.edu.au
Contact person for public queries
Name 90555 0
Charlotte Hespe
Address 90555 0
Head, General Practice and Primary Care Research

School of Medicine, Sydney

The University of Notre Dame Australia

160 Oxford St, Darlinghurst, NSW 2010

PO Box 944 Broadway, NSW 2007
Country 90555 0
Australia
Phone 90555 0
+61 02 8204 4461
Fax 90555 0
Email 90555 0
charlotte.hespe@nd.edu.au
Contact person for scientific queries
Name 90556 0
Charlotte Hespe
Address 90556 0
Head, General Practice and Primary Care Research

School of Medicine, Sydney

The University of Notre Dame Australia

160 Oxford St, Darlinghurst, NSW 2010

PO Box 944 Broadway, NSW 2007
Country 90556 0
Australia
Phone 90556 0
+61 02 8204 4461
Fax 90556 0
Email 90556 0
charlotte.hespe@nd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participant confidentiality will be maintained


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.