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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vision Impairment

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Neurological

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]

Treatment: Other

Intervention code [2]

Behaviour

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]

Depression

Timepoint [1]

Baseline (pre-EFT or control condition) and post the EFT or control condition intervention, and 3-month followup for EFT group

Primary outcome [2]

Anxiety

Timepoint [2]

Baseline (pre-EFT or control condition) and post the EFT or control condition intervention, and 3-month followup for the EFT intervention

Primary outcome [3]

Anger

Timepoint [3]

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]

vision functioning

Timepoint [1]

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]

quality of life in 4 areas: physical health, psychological health, social relationships, and environment - this will be assessed as a composite outcome

Timepoint [2]

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?

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]

New Zealand

State/province [1]

Country [2]

United States of America

State/province [2]

all states

Country [3]

United Kingdom

State/province [3]

all areas

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Peta Stapleton

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

Bond University

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

Bond University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

https://bond.edu.au/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2023

Approval date [1]

01/12/2023

Ethics approval number [1]

Summary

Brief summary

Vision impairment (VI) is considered to be a serious public health issue, affecting more than 4 million people aged at least 40 years in the United States and at least 2.2 billion people worldwide. It is also estimated that over 13 million Australians have one or more chronic (long-term) eye conditions or VI, according to self-reported data from the Australian Bureau of Statistics (ABS). VI has a profound effect on overall levels of health related quality of life (HRQOL) in the individuals who suffer from it, and a significant association between VI and psychological issues such as anxiety and depression has been found. Although there is quite a robust association found in the literature regarding VI and the development of depression, anxiety remains an understudied topic as an associated psychological aspect of VI. Some studies have found that there is indeed a positive association between the incidence of VI and the development of anxiety, however other studies do not find a relationship.

The aim of this study is to offer participants an 8-week self-directed psychological intervention program, which may impact psychological concerns such as anxiety and depression. An initial 2006 (unpublished) 8-week trial of Emotional Freedom Techniques (EFT) for eyesight conditions and anxiety found in a sample of 120 adult volunteers, there was a significant difference between men and women in terms of overall eyesight improvement (p=.022; Look, 2006).  This research will also explore the psychological issues associated with VI in adults.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peta Stapleton

Address

School of Psychology Bond University University Dr Robina Queensland Australia 4229

Country

Australia

Phone

+61 755952515

Fax

[email protected]

Contact person for public queries

Name

Peta Stapleton

Address

School of Psychology Bond University University Dr Robina Queensland Australia 4229

Country

Australia

Phone

+61 755952515

Fax

[email protected]

Contact person for scientific queries

Name

Peta Stapleton

Address

School of Psychology Bond University University Dr Robina Queensland Australia 4229

Country

Australia

Phone

+61 755952515

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal, or case-by-case basis at the
discretion of Primary investigator

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified/anonymous raw line-by-line data collected from each participant.

What types of analyses could be done with individual participant data?

• meta analyses etc

When can requests for individual participant data be made (start and end dates)?

From:
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)

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• The Principal Investigator on [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23874	Ethical approval					PS00212_BUHREC approval letter_Gatekeeper.pdf

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.

Trial Review

Documents added manually

Documents added automatically