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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]

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

Anxiety

Insomnia

Medically unexplained pain

Condition category

Condition code

Mental Health

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]

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]

Symptoms of PTSD (composite outcome) as measured by the scores on the PCL-5

Timepoint [1]

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]

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]

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?

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]

Commercial sector/Industry

Name [1]

Trauma and Pain Management Services Pty Ltd

Address [1]

1 Holroyd Street, Kew VIC 3101

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Royal Melbourne Hospital HREC

Ethics committee address [1]

Level 2, Southwest
300 Grattan Street
Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/11/2021

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study aims to investigate whether daily self-use (for one month) of four apps designed to ameliorate four of the main symptoms of PTSD (anxiety, insomnia, medically unexplained symptoms and decreased self-confidence) can facilitate reduced symptoms.

Trial website

https://www.traumaapps.com/app-study

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Mark Grant

Address

Trauma and Pain Management Services Pty Ltd
1 Holroyd Street, Kew, VIC 3101

Country

Australia

Phone

+61 398528947

Fax

61398528947

markgra@ozemail.com.au

Contact person for public queries

Name

Mark Grant

Address

Trauma and Pain Management Services Pty Ltd
contact: Mark Grant
1 Holroyd Street, Kew, VIC 3101

Country

Australia

Phone

+61 398528947

Fax

61398528947

markgra@ozemail.com.au

Contact person for scientific queries

Name

Mark Grant

Address

Trauma and Pain Management Services Pty Ltd
1 Holroyd Street, Kew, VIC 3101

Country

Australia

Phone

+61 398528947

Fax

61398528947

markgra@ozemail.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

there is no need to share individual data

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Attachment
16081	Study protocol		https://www.traumaapps.com/app-study	markgra@ozemail.com.au	384069-(Uploaded-15-05-2022-20-43-24)-Study-related document.docx
16082	Informed consent form		https://www.traumaapps.com/app-study
16083	Ethical approval	ethical 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.

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