Trial Review

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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 information initially 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] 295580 0
none
Universal Trial Number (UTN)
U1111-1217-5685
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 308866 0
Condition category
Condition code
Mental Health 307789 307789 0 0
Other mental health disorders
Mental Health 307883 307883 0 0
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] 301878 0
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] 306774 0
To test cortisol (stress hormone) level via serum assay test (saliva)
Timepoint [1] 306774 0
30 minutes before intervention and 30 minutes after (1 hour intervention length)
Secondary outcome [1] 349555 0
To determine impact of intervention on psychological distress symptoms via the Symptom Assessment-45 measure
Timepoint [1] 349555 0
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
90
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 300157 0
Charities/Societies/Foundations
Name [1] 300157 0
Association of Comprehensive Energy Psychology
Country [1] 300157 0
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] 299565 0
None
Name [1] 299565 0
Address [1] 299565 0
Country [1] 299565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300988 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 300988 0
Bond University
University Dr
Robina QLD 4229
Australia
Ethics committee country [1] 300988 0
Australia
Date submitted for ethics approval [1] 300988 0
01/06/2018
Approval date [1] 300988 0
13/08/2018
Ethics approval number [1] 300988 0

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 85526 0
A/Prof Peta Stapleton
Address 85526 0
School of Psychology
University Drive
Bond University
Robina QLD 4229
Country 85526 0
Australia
Phone 85526 0
+61755952515
Fax 85526 0
Email 85526 0
[email protected]
Contact person for public queries
Name 85527 0
Peta Stapleton
Address 85527 0
School of Psychology
University Drive
Bond University
Robina QLD 4229
Country 85527 0
Australia
Phone 85527 0
+61755952515
Fax 85527 0
Email 85527 0
[email protected]
Contact person for scientific queries
Name 85528 0
Peta Stapleton
Address 85528 0
School of Psychology
University Drive
Bond University
Robina QLD 4229
Country 85528 0
Australia
Phone 85528 0
+61755952515
Fax 85528 0
Email 85528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
protected information with identifying data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2625Study protocolin published journal article when available (currently under review) [email protected]
2626Informed consent formin published journal article when available (currently under review) [email protected]
2627Ethical approvalin published journal article when available (currently under review) [email protected]



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
2980Plain language summaryNo This study examined changes in stress biochemistry... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReexamining the effect of emotional freedom techniques on stress biochemistry: A randomized controlled trial.2020https://dx.doi.org/10.1037/tra0000563
N.B. These documents automatically identified may not have been verified by the study sponsor.