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Trial registered on ANZCTR


Registration number
ACTRN12620000585921
Ethics application status
Approved
Date submitted
23/04/2020
Date registered
21/05/2020
Date last updated
21/05/2020
Date data sharing statement initially provided
21/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does online delivery of Emotional Freedom Techniques for Chronic Pain work as well as attending treatment live in person but also online?
Scientific title
Online Treatment of Chronic Pain Severity and Psychological Variables in Adults using Emotional Freedom Techniques
Secondary ID [1] 301113 0
Nil known
Universal Trial Number (UTN)
U1111-1250-8289
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 317201 0
Condition category
Condition code
Mental Health 315344 315344 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 315461 315461 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive either:
- a weekly video email of the treatment program (a clinical and health psychologist with 22 years experience) which will teach the treatment process (which is the EFT technique) via pre-recorded video of 20-30 minutes for that week (it is self paced for 6 weeks). Weekly handouts of 1-2 pages that outline the topic for the week and email support from the lead researchers will also be supplied.
- or attend live online during a set time to be presented the same weekly information with experienced psychologists via an online e-platform.
Participants will be randomly allocated to the 2 treatment options (via computer randomisation tool).

Therefore both programs will be: an online education intervention, with human-support.

Each person will engage 1-2 hours per week for the intervention (which is the EFT being demonstrated) and a further 20-30 minutes at the beginning, end and followup points to complete the questionnaires.

The topics which will be covered in the 6-weeks both in the live online version and online self paced version include: Psycho-education about the treatment and how it works; The nature of chronic pain; Feelings and pain; secondary gain issues with pain; sleep hygiene; and Goal setting.

Adherence will be monitored in the self paced version by drip releasing the content 1 week at a time so participants won't skip ahead. They will also be asked to complete a weekly evaluation about the content that week and video analytics will be reviewed for watch time and engagement. Non adherence will be noted and followed up by the lead investigator via email. Adherence in the live group will be noted as attendance by the facilitators and the same weekly evaluation will be completed. Non attendance will be followed up by the lead investigator again.

The technique is EFT - or Emotional Freedom Techniques. EFT is a brief novel intervention combining elements of exposure and cognitive therapy, and somatic stimulation. It is often referred to as ‘psychological acupuncture’ and uses a two finger tapping process with a cognitive statement.
Intervention code [1] 317418 0
Treatment: Other
Comparator / control treatment
Wait list - group that will complete surveys up front, but then wait the length of treatment (6 weeks), before undergoing the treatment (both options).
Control group
Active

Outcomes
Primary outcome [1] 323595 0
Change in the impact and intensity of pain as measured by the Brief Pain Inventory
Timepoint [1] 323595 0
baseline and post treatment (week 6 primary endpoint), and 6 and 12 months post treatment end
Primary outcome [2] 323596 0
Change in judgement of satisfaction with life, as measured by the Satisfaction With Life Scale.
Timepoint [2] 323596 0
baseline and post treatment (week 6 primary endpoint), and 6 and 12 months post treatment end
Secondary outcome [1] 382308 0
Change in depression, as measured by the Patient Health Questionnaire
Timepoint [1] 382308 0
baseline and post treatment (week 6 primary endpoint), and 6 and 12 months post treatment end
Secondary outcome [2] 382658 0
Change in the cause, duration, and severity of a current activity limitation an individual may have in his or her life as measured by the Health Related Quality of Life Questionnaire (note this is a single variable)
Timepoint [2] 382658 0
baseline and post treatment (week 6 primary endpoint), and 6 and 12 months post treatment end
Secondary outcome [3] 382659 0
Change in sleeplessness as measured by the Health Related Quality of Life
Timepoint [3] 382659 0
baseline, and post treatment (week 6 primary endpoint), and 6 and 12 months post treatment end
Secondary outcome [4] 382660 0
Change in vitality as measured by the Health Related Quality of Life Questionnaire
Timepoint [4] 382660 0
baseline, and post treatment (week 6 primary endpoint), and 6 and 12 months post treatment end

Eligibility
Key inclusion criteria
18 years and over
Endorsement of chronic pain for at least 6 months out of the past 12 months, and that has negatively impacted overall functioning and quality of life
Chronic pain without clear organic/physical caused determined by primary care physician or specialist
Current pain rating of 4 or higher on 0 to 10 scale (10 = worst pain)
Access to internet, email
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- currently engaged in another psychotherapy treatment intervention for chronic pain (e.g. cognitive behavioural therapy)
- having a a major psychiatric disorder (e.g. bipolar disorder)
- currently in high-intensity substance use disorder treatment program
- malignant pain caused by cancer pain syndrome
- referred pain such as back pain caused by pancreatitis
- co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus erythematosus
- planned major surgical procedure within the next 90 days

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)
Allocation concealment will occur by 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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Allocation concealment will occur by central randomisation by computer
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A repeated measures ANOVA will be used to investigate the changes in mean scores over the 4 time points (pre, post, 6 and 12 month followup) in both online treatment group (within measures as well as between groups). A g*power analysis will be conducted to determine an appropriate sample size to achieve a moderate effect size (80% power at 0.05 significance level) - A g*power analysis suggests 122 participants in total for this study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22508 0
United States of America
State/province [1] 22508 0
Country [2] 22509 0
United Kingdom
State/province [2] 22509 0
Country [3] 22510 0
New Zealand
State/province [3] 22510 0

Funding & Sponsors
Funding source category [1] 305556 0
University
Name [1] 305556 0
Bond University School of Psychology
Address [1] 305556 0
Bond University
School of Psychology
University Dr, Robina, Queensland
Australia 4226
Country [1] 305556 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Bond University
School of Psychology
University Dr, Robina, Queensland
Australia 4226
Country
Australia
Secondary sponsor category [1] 305962 0
None
Name [1] 305962 0
Address [1] 305962 0
Country [1] 305962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305863 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 305863 0
Bond University
School of Psychology
University Dr, Robina, Queensland
Australia 4226
Ethics committee country [1] 305863 0
Australia
Date submitted for ethics approval [1] 305863 0
Approval date [1] 305863 0
21/04/2020
Ethics approval number [1] 305863 0

Summary
Brief summary
Current chronic pain affects 20-33% of the US adult population (~50+ million adults) and represents a major health care crisis due its associated disabling physical and emotional problems, while resulting in US healthcare costs up to $635 billion a year. Several innovative mind-body somatic interventions have emerged as potential treatments for chronic pain, EFT being one such treatment. Existing research into EFT and chronic pain is limited although preliminary studies show promise. This study is being pursued because of the increase in need for chronic pain interventions., and is being offered online to test the ability to support people in remote and rural areas. This will also allow comparison between a live online version versus a self paced option.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101850 0
A/Prof Peta Stapleton
Address 101850 0
School of Psychology
Bond University
University Dr Robina QLD 4226
Country 101850 0
Australia
Phone 101850 0
+61755952515
Fax 101850 0
Email 101850 0
pstaplet@bond.edu.au
Contact person for public queries
Name 101851 0
A/Prof Peta Stapleton
Address 101851 0
School of Psychology
Bond University
University Dr Robina QLD 4226
Country 101851 0
Australia
Phone 101851 0
+61755952515
Fax 101851 0
Email 101851 0
pstaplet@bond.edu.au
Contact person for scientific queries
Name 101852 0
A/Prof Peta Stapleton
Address 101852 0
School of Psychology
Bond University
University Dr Robina QLD 4226
Country 101852 0
Australia
Phone 101852 0
+61755952515
Fax 101852 0
Email 101852 0
pstaplet@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results