Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000779572
Ethics application status
Approved
Date submitted
11/06/2024
Date registered
25/06/2024
Date last updated
25/06/2024
Date data sharing statement initially provided
25/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Emotional Freedom Technique for Vision Impairment and Psychological Issues: A randomised online trial
Scientific title
Efficacy of Clinical EFT for Symptom Management in Vision Impairment and Psychological Issues: A randomised online trial
Secondary ID [1] 312316 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision Impairment 334071 0
Condition category
Condition code
Mental Health 330742 330742 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 330797 330797 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emotional Freedom Techniques (EFT) is a type of exposure therapy which includes a somatic and cognitive component for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. Likened to a version of psychological acupuncture but without the use of fine needles, EFT combines components of traditional approaches (including cognitive and exposure therapy) with acupoint stimulation. By using a tapping technique (with two fingers) to stimulate acupressure points on the face and upper body, and incorporating a cognitive element that involves the individual states his/her concern aloud as he/she performs the tapping.

Participants will watch a video course online of the EFT process over 8 weeks (one video per week), and follow along with the EFT technique for that week's topic. The topics will relate to psychological issues that have been shown to affect vision impairment.

It will take 15 minutes and can be done privately at home, online and anonymously. The video for the week can be watched as many times as the person likes.

Participants will be randomly allocated to the EFT intervention or waitlist control group via computer randomisation. They will complete the pre and post measure package online before and after the 8 week course.

The 8 topics presented in the trial are:
week 1 - introduction to EFT and the topic of resistance
2 - fear
3 - guilt
4 - anger
5 - anxiety
6 - beliefs about eyesight and VI
7 - resentment
8 - remaining blocks to clear vision and conclusion

Participants will only be asked to watch the video once during the week and apply the intervention - they are not required to do this more than once a week. We will be able to track through the website data, the amount of time spent on the video, and how many times the watched it (eg they can rewind and watch again). The are unable to move forward in the program until 7 days after the first video - they are released every 7 days, although the previous videos are there still - we will be able to see if they revisit them through website data.
Intervention code [1] 328789 0
Behaviour
Intervention code [2] 328790 0
Treatment: Other
Comparator / control treatment
Waitlist control group - will be offered the intervention after their waiting time (8 weeks)
They are not offered any other interventions during the waiting time.
Control group
Active

Outcomes
Primary outcome [1] 338501 0
Anxiety
Timepoint [1] 338501 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention, and 3-month followup for the EFT intervention
Primary outcome [2] 338502 0
Depression
Timepoint [2] 338502 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention, and 3-month followup for EFT group
Primary outcome [3] 338503 0
Anger
Timepoint [3] 338503 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention, and 3 month followup - only the EFT group will be followed up at 3-months
Secondary outcome [1] 436189 0
vision functioning
Timepoint [1] 436189 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention and 3-month followup - only the EFT group will be followed up at 3-months
Secondary outcome [2] 436190 0
quality of life in 4 areas: physical health, psychological health, social relationships, and environment - this will be assessed as a composite outcome
Timepoint [2] 436190 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention and 3-month followup - only the EFT group will be followed up at 3-months

Eligibility
Key inclusion criteria
- must have moderate visual impairment but not poor (see exclusion)
- must be between the ages of 18-80 years of age,
- all genders are welcomed,
- all nationalities are invited,
- speak English,
- have access to the internet for the online videos and surveys,
- be able to watch the videos online and follow the self-applied intervention
- be able to give informed consent and participate in the trial over 8 weeks,
- participants must have either 1) an official have a medical diagnosis of an eye condition or disease such as cataracts, age-related macular degeneration, diabetic retinopathy, glaucoma, cytomegalovirus retinitis, which causes them to experience VI or 2) self reported vision loss or self reported problems with their eyesight from any cause.

Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have complete loss of sight or very low vision may find they cannot watch the videos and/or complete the surveys with ease.


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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) and will be centralised
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
One way analysis of variance will be used to determine whether or not there is a statistically significant difference between the means of the EFT or control groups on the measures

An a priori power analysis was conducted using G*Power version 3.1.9.7 (Faul et al., 2007) for sample size estimation.
With a significance criterion for 2 groups (EFT vs control) of a = .05 and power = .90, the minimum sample size needed with this effect size is N = 100 for ANOVA (for 7 measurements).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/06/2024
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
250
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26367 0
United States of America
State/province [1] 26367 0
all states
Country [2] 26368 0
United Kingdom
State/province [2] 26368 0
all areas
Country [3] 26369 0
New Zealand
State/province [3] 26369 0

Funding & Sponsors
Funding source category [1] 316711 0
Self funded/Unfunded
Name [1] 316711 0
Dr Peta Stapleton
Country [1] 316711 0
Australia
Funding source category [2] 316712 0
University
Name [2] 316712 0
Bond University
Country [2] 316712 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Country
Australia
Secondary sponsor category [1] 318916 0
None
Name [1] 318916 0
Address [1] 318916 0
Country [1] 318916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315487 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 315487 0
Ethics committee country [1] 315487 0
Australia
Date submitted for ethics approval [1] 315487 0
15/08/2023
Approval date [1] 315487 0
01/12/2023
Ethics approval number [1] 315487 0

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

Contacts
Principal investigator
Name 134850 0
Prof Peta Stapleton
Address 134850 0
School of Psychology Bond University University Dr Robina Queensland Australia 4229
Country 134850 0
Australia
Phone 134850 0
+61 755952515
Fax 134850 0
Email 134850 0
[email protected]
Contact person for public queries
Name 134851 0
Peta Stapleton
Address 134851 0
School of Psychology Bond University University Dr Robina Queensland Australia 4229
Country 134851 0
Australia
Phone 134851 0
+61 755952515
Fax 134851 0
Email 134851 0
[email protected]
Contact person for scientific queries
Name 134852 0
Peta Stapleton
Address 134852 0
School of Psychology Bond University University Dr Robina Queensland Australia 4229
Country 134852 0
Australia
Phone 134852 0
+61 755952515
Fax 134852 0
Email 134852 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?
De-identified/anonymous raw line-by-line data collected from each participant.
When will data be available (start and end dates)?
Start will be end of the trial (likely to be 31st July 2024)
There won't be an end date as we will store in an accessible data storage (e.g. OSF)
Available to whom?
only researchers who provide a methodologically sound proposal, or case-by-case basis at the
discretion of Primary investigator
Available for what types of analyses?
meta analyses etc
How or where can data be obtained?
The Principal Investigator on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23874Ethical approval    387948-(Uploaded-11-06-2024-11-37-55)-PS00212_BUHREC approval letter_Gatekeeper.pdf



Results publications and other study-related documents

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