Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000748718p
Ethics application status
Submitted, not yet approved
Date submitted
16/05/2022
Date registered
25/05/2022
Date last updated
25/05/2022
Date data sharing statement initially provided
25/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized control trial regarding the efficacy of an app series based on Eye Movement Desensitization and Reprocessing (EMDR) for Posttraumatic Stress Disorder (PTSD) symptoms.
Scientific title
A randomized control trial on the efficacy of app series based on EMDR for managing symptoms of PTSD.
Secondary ID [1] 307134 0
Nil known
Universal Trial Number (UTN)
U1111-1278-3123
Trial acronym
EMDRAPPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 326311 0
Anxiety 326312 0
Insomnia 326313 0
Medically unexplained pain 326314 0
Condition category
Condition code
Mental Health 323680 323680 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily at home use of minimum 15 mins/day for one month of 1 or more of the following 4 mobile apps:

1. The Anxiety Release App incorporates brain training exercises, guided anxiety management sessions and bilateral stimulation material in audio and video formats. The purpose is to stimulate the brain with bilateral stimulation (alternating audio and/or visual stimuli), which captures attention processes and diverts emotional resources. It is predicted that the exercises would help release anxiety using sensory and auditory bilateral stimulation.
16 app sessions that vary between 10 and 20 minutes.

2. The Overcomingpain app is designed to decrease medically unexplained symptoms associated with trauma. This app comprises 20 sessions incorporating a mix of bilateral stimulation (BLS), pain-relieving imagery and suggestions and behavioral exercises divided into three playlists targeting mental and emotional dimensions of chronic pain;
1. Mental Healing strategies,
2. Sensory Healing strategies and
3. Stress Management. created by the author before the era or mobile apps.
Sessions are played in any order selected by the user.
24 app sessions vary between 10 and 20 minutes.

3. The Sleep Restore app was developed to specifically address the effects of traumatic stress which lead to insomnia, namely: trouble falling asleep, night-waking, hypervigilance, worry, nightmares and feelings of lack of safety. Based on the response collected from each participant in the online assessment, the Sleep Restore app will automatically generate a unique meditation playlist from 18 sessions of pre-installed guided EMDR-based treatment materials including: BLS (natural sounds, music and story reading), individually designed to address the different effects of stress. Materials will be available immediately after completion of baseline assessments. Participants will be instructed to utilize these materials whenever they experience trouble falling asleep. They will also be encouraged to revisit the app more often in order to unlock extra treatment materials.
20 app sessions that vary between 10 and 20 minutes.

4. The Calm and Confident app incorporates guided meditations. BLS and ego-enhancing suggestions to stimulate decreased tension, relaxation and increased confidence. In addition to decreasing stress, this app aims to facilitate a relaxed state of well-being in the listener. The 10 tracks include session targeting stress and anxiety relief, emotional integration and self-worth. This app is based on a CD of the same name, created by the author before the era or mobile apps.
7 app sessions vary between 10 and 20 minutes.
Usage will be monitored by a 'Daily App Usage Log' which participants will be provided with.
Participants choose whichever one or more of the four apps they want to use according to their daily needs.
Intervention code [1] 323591 0
Treatment: Other
Comparator / control treatment
waitlist control group - will not receive treatment during study but will be given intervention upon completion of treatment phase (ie; one month after the last treatment subject has completed their treatment phase) .
Control group
Active

Outcomes
Primary outcome [1] 331382 0

Symptoms of PTSD (composite outcome) as measured by the scores on the PCL-5
Timepoint [1] 331382 0
One month post commencement of intervention
then 3 month follow-up following cessation of intervention
then 6 month follow-up following cessation of intervention
Secondary outcome [1] 409672 0
Medically unexplained symptoms (MUS) as measured by the PHQ-15 (Patient health questionnaire) at one month following commencement of intervention and 3 and 6 months following cessation of intervention.
Timepoint [1] 409672 0
1. One month following commencement of intervention
2. 3 months following cessation of intervention
3. 6 months following cessation of intervention

Eligibility
Key inclusion criteria
Diagnosis of PTSD, or symptoms consistent with PTSD as measured by PCL-C and over age 18.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Lack of access to mobile apps; (2) on-going self-harm/suidical or homidical ideation, (3) diagnosis of psychotic or bipolar disorder (4) non-English speakers; (5) diagnosis of dissociative disorder (6) organic mental disorder (7) substance abuse and (8) significant cognitive impairment (eg; severe intellectual disability, dementia).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size required was determined by performing statistical power analysis. An effect size of d = 0.4 was used as it’s a good estimate of the smallest effect size that has practical relevance (Brysbaert, 2019). Power was set to 80%. Alpha = 0.05. The total number of subjects required is 200 (100 in the treatment group, 100 in the waitlist control group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311438 0
Commercial sector/Industry
Name [1] 311438 0
Trauma and Pain Management Services Pty Ltd
Country [1] 311438 0
Australia
Primary sponsor type
Individual
Name
Mark D Grant
Address
Trauma and Pain Management Services Pty Ltd
1 Holroyd Street, Kew VIC 3101
Country
Australia
Secondary sponsor category [1] 312833 0
None
Name [1] 312833 0
Address [1] 312833 0
Country [1] 312833 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310916 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 310916 0
Ethics committee country [1] 310916 0
Australia
Date submitted for ethics approval [1] 310916 0
03/11/2021
Approval date [1] 310916 0
Ethics approval number [1] 310916 0

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

Contacts
Principal investigator
Name 119334 0
Mr Mark Grant
Address 119334 0
Trauma and Pain Management Services Pty Ltd
1 Holroyd Street, Kew, VIC 3101
Country 119334 0
Australia
Phone 119334 0
+61 398528947
Fax 119334 0
61398528947
Email 119334 0
[email protected]
Contact person for public queries
Name 119335 0
Mark Grant
Address 119335 0
Trauma and Pain Management Services Pty Ltd
contact: Mark Grant
1 Holroyd Street, Kew, VIC 3101
Country 119335 0
Australia
Phone 119335 0
+61 398528947
Fax 119335 0
61398528947
Email 119335 0
[email protected]
Contact person for scientific queries
Name 119336 0
Mark Grant
Address 119336 0
Trauma and Pain Management Services Pty Ltd
1 Holroyd Street, Kew, VIC 3101
Country 119336 0
Australia
Phone 119336 0
+61 398528947
Fax 119336 0
61398528947
Email 119336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
there is no need to share individual data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16081Study protocol https://www.traumaapps.com/app-study[email protected] 384069-(Uploaded-15-05-2022-20-43-24)-Study-related document.docx
16082Informed consent form https://www.traumaapps.com/app-study 
16083Ethical approvalethical approval is in submission  



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.