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Trial registered on ANZCTR


Registration number
ACTRN12623000538640
Ethics application status
Approved
Date submitted
4/05/2023
Date registered
22/05/2023
Date last updated
22/05/2024
Date data sharing statement initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Emotional Freedom Techniques (Tapping) for Building Forgiveness
Scientific title
A randomised clinical trial of Emotional Freedom Techniques (EFT) versus control for forgiveness among adults who have had a transgression
Secondary ID [1] 309601 0
Nil
Universal Trial Number (UTN)
U1111-1292-1616
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resentment 329913 0
Condition category
Condition code
Mental Health 326823 326823 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 326919 326919 0 0
Other mental health 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 online of the EFT process, and follow along for their own recent experience of being 'hurt' (a transgression) or having resentment towards someone external. It will take 30 minutes and can be done privately at home, online and anonymously.
Participants will be randomly allocated ot the EFT intervention or control group via computer randomisation. This is a single session of 30 minutes only. They will complete the pre and post measure package online before and after the session. It will be anonymous.
Intervention code [1] 326024 0
Behaviour
Intervention code [2] 326102 0
Treatment: Other
Comparator / control treatment
The control group will complete various colour/shape matching exercises before and after the questionnaire package while they still think of a recent transgression someone did to them. The session is 30 minutes duration and online delivery.
Control group
Active

Outcomes
Primary outcome [1] 334665 0
Positive, benevolent motivations as measured by the Trasngression-Related Interpersonal Motivations (TRIM) Inventory 18.
Timepoint [1] 334665 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention
Primary outcome [2] 334666 0
Empathy as measured by the Batson Empathy Scale
Timepoint [2] 334666 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention
Primary outcome [3] 334667 0
State specific rumination as measured by the Rumination about an Interpersonal Offense Scale
Timepoint [3] 334667 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention
Secondary outcome [1] 421621 0
Perceived injustice gap as measured by the Injustice Gap Scale
Timepoint [1] 421621 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention
Secondary outcome [2] 421622 0
positive and negative emotions as measured by the Positive and Negative Affect Schedule (PANAS10) - these are both assessed within this 1 measure as secondary outcomes
Timepoint [2] 421622 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention
Secondary outcome [3] 421623 0
stress feelings as measured by a single item likert scale
Timepoint [3] 421623 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention
Secondary outcome [4] 421624 0
core symptoms/signs of depression and anxiety as measured by the Patient Health Questionnaire-4 - these are both assessed within the 1 measure as secondary outcomes
Depression and anxiety be analysed together as a composite outcome
Timepoint [4] 421624 0
Baseline (pre-EFT or control condition) and post the EFT or control condition intervention

Eligibility
Key inclusion criteria
This study is for adults 18 years+ who have had a transgression (i.e. someone who has 'hurt' them and they wish to release that feeling).
Access to the internet is needed, and English speaking
Must be willing to be randomly allocated to either the EFT intervention or a control condition
Willing to complete the baseline and post questionnaire, and have 30 minutes available to complete the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years

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)
central randomisation by the computer program
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
Completed
Date of first participant enrolment
Anticipated
30/06/2023
Actual
30/06/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
1/12/2023
Date of last data collection
Anticipated
31/10/2023
Actual
1/12/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25431 0
United States of America
State/province [1] 25431 0
all states are eligible

Funding & Sponsors
Funding source category [1] 313783 0
Self funded/Unfunded
Name [1] 313783 0
Dr Peta Stapleton
Country [1] 313783 0
Australia
Primary sponsor type
University
Name
Bond University
Address
School of Psychology
Bond University
University Dr
Robina Queensland Australia 4229
Country
Australia
Secondary sponsor category [1] 315616 0
University
Name [1] 315616 0
Luther College
Address [1] 315616 0
Luther College
School of Psychology
700 College Drive
Decorah, Iowa 52101 USA
Country [1] 315616 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312951 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 312951 0
Ethics committee country [1] 312951 0
Australia
Date submitted for ethics approval [1] 312951 0
17/02/2022
Approval date [1] 312951 0
03/06/2022
Ethics approval number [1] 312951 0
PS00190

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

Contacts
Principal investigator
Name 126454 0
A/Prof Peta Stapleton
Address 126454 0
School of Psychology
Bond University
University Dr
Robina Queensland Australia 4229
Country 126454 0
Australia
Phone 126454 0
+61 755952515
Fax 126454 0
Email 126454 0
[email protected]
Contact person for public queries
Name 126455 0
Peta Stapleton
Address 126455 0
School of Psychology
Bond University
University Dr
Robina Queensland Australia 4229
Country 126455 0
Australia
Phone 126455 0
+61 755952515
Fax 126455 0
Email 126455 0
[email protected]
Contact person for scientific queries
Name 126456 0
Peta Stapleton
Address 126456 0
School of Psychology
Bond University
University Dr
Robina Queensland Australia 4229
Country 126456 0
Australia
Phone 126456 0
+61 755952515
Fax 126456 0
Email 126456 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 October 2023)
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 analysis
How or where can data be obtained?
The Principal Investigator on [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19093Ethical approval    385849-(Uploaded-04-05-2023-16-30-58)-Study-related document.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.