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Trial registered on ANZCTR

Registration number

ACTRN12618001272280

Ethics application status

Approved

Date submitted

17/07/2018

Date registered

27/07/2018

Date last updated

3/07/2019

Date data sharing statement initially provided

3/07/2019

Date results provided

3/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

How does emotional freedom techniques impact stress hormones in adults

Scientific title

The Effect of Emotional Freedom Techniques on Stress Biochemistry in Australian Adults: A Replication and Extension of Church et al. 2012

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1217-5685

Trial acronym

Linked study record

Health condition

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

stress

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Emotional Freedom Techniques (Craig, 2011) 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. A tapping technique (with two fingers)is used to stimulate 8 pressure points on the face and upper body, with a cognitive element that involves the individual stating his/her concern aloud as he/she performs the tapping. The 8 points are exactly the same for every person in the trial and done in the same order as per the original recipe (Craig, 2011). They are standardised.
In the EFT and psychotherapy group, a powerpoint will be used to illustrate the information being discussed (e.g. image on the tapping points). Both groups will be lead by registered clinical psychologists, and the psychologist in the EFT group is a certified practitioner in the technique. The mode of delivery will be groups of 10 adults for both conditions, and in person face to face. The interventions will be delivered once only for 60 minutes and will be held on campus at the University on a designated day.
The psychotherapy group will have the powerpoint for the full 60 minutes of the intervention and be taught information in lecture style, relating to the stress response and how stress affects the body. There will be no further information provided beyond this.
In the EFT group the participants will be taught the technique for stress reduction and they will apply it in session.

Intervention code [1]

Treatment: Other

Comparator / control treatment

We will be directly replicating the existing study; but will conduct the sessions in groups of 10-12 adults, rather than offering individual sessions. Group treatment of EFT has been established as effective and cost of delivering the sessions individually prohibits this aspect (Church & House, 2018).

120 adults (18+ years) will be recruited for a stress study. When participants make contact for an appointment, they will be randomly assigned to a no treatment (NT) session (in a group), an EFT session (in a group), or a Supportive Interview session based on a CBT format (focused on establishing rapport, listening to the client’s presenting issues, expressing empathy, and challenging negative cognitions; again in a group setting). Participants will sign consent, provide a saliva sample and complete measures prior to the first session, while waiting for their session. The NT group will wait in their intervention room reading magazines prior to the second saliva test and this will be the same duration (60 minutes). This group will be supervised during this time so they are engaging in reading magazines only..

Control group

Active

Outcomes

Primary outcome [1]

To test cortisol (stress hormone) level via serum assay test (saliva)

Timepoint [1]

30 minutes before intervention and 30 minutes after (1 hour intervention length)

Secondary outcome [1]

To determine impact of intervention on psychological distress symptoms via the Symptom Assessment-45 measure

Timepoint [1]

30 minutes before and after the 1 hour intervention

Eligibility

Key inclusion criteria

Between ages 18- 80 years; both genders

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants cannot be taking any of these medications to participate in the aspect of cortisol testing (due to potential effects):

• Antidepressants
• Steroids
• Hormonal medication (eg for Menopause)
• Thyroid medication
• Diabetes medication (including insulin)
• Contraceptives (e.g Pill)
• Be pregnant, undergoing menopause currently or have Cushing’s disease

As per the original study, Subjects will also be excluded if they describe a history of major depressive disorder, PTSD, or chronic diseases characterized by abnormal cortisol levels.
Furthermore, subjects will also be excluded from the final analysis if the therapist conducting the session reports the recall of an emotionally significant trauma during the last 20 minutes of the session. The theoretical basis for this criterion (and included in the original study) is the likelihood that cortisol will rise during and immediately after such recall.

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 computer

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 analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

120 adults (18+ years) will be recruited for a stress study (40 per group). This will allow enough power for the study at 80% and an moderate effect size and replicates the original study.

Cortisol analysis will be done by:

Dr. Hayley M. O’Neill
Postdoctoral Research Fellow/ Research Manager
(NHMRC Peter Doherty Early Career Fellow)
Bond University
Faculty of Health Science and Medicine

Pre-post outcome measures will be psychological distress symptoms and cortisol levels. Psychological distress symptoms will be
assessed using the symptom assessment-45 (SA-45), a validated instrument with 45 items scored on a scale from 1 to 5 (Davison et al., 1997; Maruish, 1999). It contains nine subscales for mental health conditions such as anxiety and depression and two general scales that measure the breadth, Positive Symptom Total (PST), and depth, General Symptom Index (GSI), of psychological symptoms. T-scores based on sex-normed data for nonclinical populations are calculated. Scores greater than 60 are considered in the clinical range. Cortisol levels will be assessed with commercially available salivary assays according to the manufacturer’s instructions. Saliva rather than serum cortisol is selected because of its ease of administration and its identification of bioavailable as opposed to total cortisol.

Demographic information will also be gathered.

Thirty minutes after the intervention sessions, (or 90 minutes later in the case of the NT group), a second SA-45 will be completed and a second saliva sample will be collected. A 30-minute interval between the end of the therapy session and cortisol collection has been found to be sufficient to allow reuptake of the hormone.

The saliva samples will be coded by number to ensure blind analysis and analysed at Bond University. The staff involved in analyses will be blind to group assignment. Therapists will be blinded to the experimental hypotheses by only being told they are assisting in a study of the effects of therapy on cortisol levels.
One-way analyses of variance will be conducted on age, the SA-45 scales, and cortisol level at baseline to determine if any baseline group differences are present.

Depending on differences between baseline of the 3 groups, ANCOVA or ANOVA will be conducted to determine changes in each session and across the psychological measure and cortisol function.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/07/2018

Actual

1/01/2019

Date of last participant enrolment

Anticipated

23/08/2018

Actual

1/02/2019

Date of last data collection

Anticipated

23/08/2018

Actual

15/03/2019

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Association of Comprehensive Energy Psychology

Address [1]

28 Garrett Ave. Suite 100
Bryn Mawr, PA. 19010 USA

Country [1]

United States of America

Primary sponsor type

University

Name

Bond University

Address

School of Psychology
Bond University
University Dr
Robina QLD 4229 Australia

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]

Bond University
University Dr
Robina QLD 4229
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/06/2018

Approval date [1]

13/08/2018

Ethics approval number [1]

Summary

Brief summary

This research is being conducted to investigate the impact of 3 different interventions on the stress hormone cortisol.

Dr Stapleton is leading the study in her role within the Faculty Society and Design, Bond University. 

What you will be asked to do 
If you have responded to a call for participants and meet the inclusion criteria, you will be randomly allocated to one of three conditions designed to impact stress levels. Firstly, you will be sent an online link for the pre-questionnaire survey.  You will then attend Bond University at a set time on a set day for a 1-hour stress intervention.  You will be asked to attend 30 minutes prior to your session for the salivary cortisol testing to be done. You will then immediately attend your 1-hour intervention, and 30 minutes after it concludes, you will be asked to provide a salivary cortisol sample again and complete your post questionnaire (same as pre-questionnaire). You will be expected to attend Bond University for a total of 2 hours maximum.

What are the 3 interventions being offered?
1.	Emotional Freedom Techniques is a type of exposure therapy which includes a somatic and cognitive component. Likened to a version of psychological acupuncture but without the use of fine needles, EFT uses a statement you say out loud while you tap on acupressure points on the face and upper body. The session will teach how to use EFT for stress reduction.
2.	Another condition will be a psychotherapy group who will receive information about how to reduce stress.
3.	The third group will be asked to enjoy reading as a way of reducing stress for the hour.

Participants will be randomly allocated to these different 1-hour treatment conditions. There will be no choice in this aspect. 

What will happen to my test sample?
Saliva samples will be used immediately or stored for future analysis. All data processing will occur by use of a unique code number and not your name. You can withdraw from the study at any time and your sample and personal information will be destroyed.  Data collected will remain in a coded format.

How participants will be selected or screened 
Participants will be called for through community advertising, and will have to be over 18 years (for consent issues), 

You CANNOT participate if:

You are taking any of these medications:
•         Antidepressants (e.g. for depression)
•         Steroids (e.g. for asthma)
•         Hormonal medication (eg for Menopause)
•         Thyroid medication
•         Diabetes medication (including insulin)
•         Contraceptives (e.g Pill)

You cannot participate if you are pregnant, undergoing menopause currently or have Cushing’s disease, a history of major depressive disorder, PTSD (post traumatic stress disorder), or chronic diseases characterized by abnormal cortisol levels (e.g. osteoporosis, hypertension or high blood pressure, diabetes).

The expected benefits of the research 
The benefits of this study will include determining the most effective brief treatment for stress.. When this is established it will form an invaluable component of future stress programs where time is limited.

Trial website

Trial related presentations / publications

Public notes

There has only been 1 study examining the effect of EFT on cortisol levels in the body, after a single EFT session. I wish to replicate this study to ascertain:
• To assure that results are reliable and valid
• To determine the role of extraneous variables
• To apply the previous results to new situations (eg food cravings)
The original paper examined the changes in cortisol levels and psychological distress symptoms of 83 non-clinical subjects receiving a single hour-long intervention. Subjects were randomly assigned to either an EFT group, a psychotherapy group receiving a supportive interview (SI), or a no treatment (NT) group. Salivary cortisol assays were performed immediately before, and thirty minutes after the intervention. Psychological distress symptoms were assessed using the Symptom Assessment Checklist -45. The EFT group showed statistically significant improvements in anxiety (-58.34%, p<0.05), depression (-49.33%, p<0.002), the overall severity of symptoms, (-50.5%, p<0.001), and symptom breadth (-41.93%, p<0.001). The EFT group experienced a significant decrease in cortisol (-24.39%, SE 2.62) compared to the decrease observed in the SI (-14.25%, SE 2.61) and NT (-14.44%, SE 2.67) groups (p<0.03). The decrease in cortisol levels in the EFT group mirrored the observed improvement in psychological distress.
This replication will investigate whether the original trial’s results are reliable and valid; and assist in deisgning future studies where cortisol can be measured (e.g. EFT as an intervention for food cravings in obese adults). 
Funding restraints prohibit the replication to include individual sessions as per the original trial. Both active interventions have been tested as group approaches in the published literature and thus for efficiency of delivery, this represents the only change to the replication. 
Group vs. individual therapy is important for both conceptual and practical reasons. Group treatment is likely to offer more opportunities for normalization, positive peer modeling, reinforcement, social support, and exposure to social situations (Manassis et al., 2002), and may also be more cost-effective (Flannery-Schroeder, Choudhury, & Kendall, 2005).
Comparative efficacy trials of individual CBT vs. Group CBT have been conducted (Flannery-Schroeder and Kendall, 2000, de Groot et al., 2007, Liber et al., 2008, Manassis et al., 2002, Muris et al., 2001). None of these trials found significant differences between the two approaches. Group application of EFT has been shown to be efficacious for treating psychological symptoms and changes persist over time (Church & House, 2018).
The discussion of the resultant publication will include the group versus individual application as a point of difference in the replication, and the possibility of group effect for any differences.

Contacts

Principal investigator

Name

A/Prof Peta Stapleton

Address

School of Psychology
University Drive
Bond University
Robina QLD 4229

Country

Australia

Phone

+61755952515

Fax

[email protected]

Contact person for public queries

Name

Peta Stapleton

Address

School of Psychology
University Drive
Bond University
Robina QLD 4229

Country

Australia

Phone

+61755952515

Fax

[email protected]

Contact person for scientific queries

Name

Peta Stapleton

Address

School of Psychology
University Drive
Bond University
Robina QLD 4229

Country

Australia

Phone

+61755952515

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

protected information with identifying data

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email
2625	Study protocol	in published journal article when available (currently under review)	[email protected]
2626	Informed consent form	in published journal article when available (currently under review)	[email protected]
2627	Ethical approval	in published journal article when available (currently under review)	[email protected]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		This study examined changes in stress biochemistry... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Reexamining the effect of emotional freedom techniques on stress biochemistry: A randomized controlled trial.	2020	https://dx.doi.org/10.1037/tra0000563

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically