Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000667819
Ethics application status
Approved
Date submitted
20/06/2012
Date registered
21/06/2012
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Food Cravings: A Comparison of Emotional Freedom Techniques, Cognitive Behavioural Therapy and a Control Group
Scientific title
In overweight and obese adults with severe food cravings, do Emotional Freedom Techniques or Cognitive Behavioural Therapy techniques result in more decreased food cravings?
Secondary ID [1] 280707 0
Nil
Universal Trial Number (UTN)
U1111-1131-3568
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Cravings 286748 0
overweight/obesity 286758 0
Condition category
Condition code
Diet and Nutrition 287047 287047 0 0
Obesity
Mental Health 287059 287059 0 0
Eating disorders
Alternative and Complementary Medicine 287063 287063 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Emotional Freedom Techniques (EFT) - meridian-based procedure which combines cognitive strategies with somatic procedures adapted from acupuncture and related systems for altering the cognitive, behavioural, and neurochemical foundations of psychological problems. It is often referred to as “psychological acupuncture” and aims to incorporate this principle of acupuncture into psychotherapeutic settings. The premise behind Thought Field Therapy (TFT) and EFT suggests that negative emotions in the body are caused by a disturbance in the body’s energy field (or meridian system). The action of stimulating acupressure points on the body (through a tapping process) while focusing the mind on the negative emotion is thought to restore the balance in the body (Craig, 2008). This act then eliminates negative emotions. Feinstein (2008) has proposed the arousal of the amygdala and other brain structures in the stress response are desensitised using EFT, where other theories highlight connective tissue transmission of piezoelectric signals (Oschman, 2006), neurotransmitter ratio alterations (dopamine and serotonin, Feinstein et al., 2005), and increased HPA axis regulation and a reduction of the stress hormone cortisol (Church, 2008).
The EFT Intervention group will receive 8 x 2 hour sessions, which will be held over 8 weeks. Treatment will be delivered in groups of 15 participants and will be demonstrated by a qualified therapist, who will instruct participants to self administer the technique.
Intervention code [1] 285127 0
Behaviour
Intervention code [2] 285128 0
Treatment: Other
Intervention code [3] 285129 0
Lifestyle
Comparator / control treatment
Cognitive Behavioural Therapy - an action-oriented form of psychosocial therapy that assumes that maladaptive, or faulty, thinking patterns cause maladaptive behavior and "negative" emotions. (Maladaptive behavior is behavior that is counter-productive or interferes with everyday living.) The treatment focuses on changing an individual's thoughts (cognitive patterns) in order to change his or her behavior and emotional state.
The CBT intervention will receive 8 x 2 hour sessions, held over 8 weeks. Treatment will be delivered by a qualified psychologist in groups of 15 participants.

Control Waitlist - will wait for duration of treatment, then receive the most effective treatment after the 8-week treatment period.
Control group
Active

Outcomes
Primary outcome [1] 287383 0
Decrease in food craving severity - measured through validated self report questionnaires (to assess frequency and severity). Questionnaire uses a likert scale of responses and is the Food Craving Inventory.
Timepoint [1] 287383 0
Pre treatment, post treatment (8 weeks), 6-month followup, 12-month followup
Primary outcome [2] 287384 0
Increase in power over food cravings - measured through validated self report questionnaires (to assess frequency and severity). Questionnaire uses a likert scale of responses and is the Power of Food Scale.
Timepoint [2] 287384 0
Pre treatment, post treatment (8 weeks), 6-month followup, 12-month followup
Primary outcome [3] 287385 0
Increase in restraint over food cravings - measured through validated self report questionnaires (to assess frequency and severity). Questionnaire use a likert scale of responses and is the Revised Restraint Questionnaire.
Timepoint [3] 287385 0
Pre treatment, post treatment (8 weeks), 6-month followup, 12-month followup
Secondary outcome [1] 298042 0
Decrease in body mass index
Timepoint [1] 298042 0
Pre treatment, post treatment (8 weeks), 6-month followup, 12-month followup
Secondary outcome [2] 298043 0
Improvement in related constructs (e.g. anxiety and somatoform concerns) - measured through validated self report questionnaires (to assess frequency and severity). Questionnaire use a likert scale of responses and is the Patient Health Questionnaire.
Timepoint [2] 298043 0
Pre treatment, post treatment (8 weeks), 6-month followup, 12-month followup

Eligibility
Key inclusion criteria
Both genders, must be overweight (i.e. Body Mass Index; BMI; between 25-29) or obese (BMI greater than 30), between18 years old and 100 years, not suffering any severe psychological impairment, not currently receiving treatment (psychological or medical) for their food cravings
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are pregnant, and known sufferers of diabetes (Type I and II) and hypoglycemia which can impact cravings will be excluded; sufferers of Anorexia Nervosa not suitable

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)
Participants will be recruited through local community announcements in print advertisements, radio, and television by the chief investigator (CI). The CI will be responsible for explaining the research purpose and process. A standard process will be used for informed consent, including a general information sheet for subjects and consent form indicating any areas of psychological risk, benefits of the study, self report questionnaire details and follow-up procedures. After screening people who respond to call for participants (to determine eligibility), 120 will be randomly assigned to either an 8-week group EFT treatment condition, a comparison 8-week group CBT condition or a waitlist control group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study was completed early
Date of first participant enrolment
Anticipated
1/05/2012
Actual
14/05/2012
Date of last participant enrolment
Anticipated
Actual
19/08/2013
Date of last data collection
Anticipated
Actual
31/07/2015
Sample size
Target
150
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285477 0
Charities/Societies/Foundations
Name [1] 285477 0
Association of Comprehensive Energy Psychology
Country [1] 285477 0
United States of America
Primary sponsor type
University
Name
Bond University
Address
Robina Gold Coast Queensland Australia 4229
Country
Australia
Secondary sponsor category [1] 284329 0
None
Name [1] 284329 0
Address [1] 284329 0
Country [1] 284329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287494 0
Bond University Research Human Ethics Committee
Ethics committee address [1] 287494 0
Bond University, Robina, Gold Coast Queensland 4229
Ethics committee country [1] 287494 0
Australia
Date submitted for ethics approval [1] 287494 0
08/02/2012
Approval date [1] 287494 0
05/03/2012
Ethics approval number [1] 287494 0
RO1465

Summary
Brief summary
Food cravings frequently lead to consumption of the craved food (Hill & Heaton-Brown, 1994), are positively correlated with BMI (Delahanty, Meigs, Hayden, Williamson, & Nathan, 2002; Franken & Muris, 2005) and obese adults report preferences for high fat foods (Drewnowski et al., 1985), therefore addressing these cravings in treatment is paramount. This study will examine treatment of food cravings in overweight or obese adults. Food craving is hypothesised to be an important intervening causal variable in the development of obesity. Research examining meridian-based procedures (e.g. Emotional Freedom Techniques, EFT) for food cravings has recently found significant improvements occurred in weight, body mass index, food cravings, subjective power of food, craving restraint and psychological coping for participants from pre- to 12-months after a 4-week treatment (p<0.05). This randomised clinical trial intends to extend this work and compare EFT treatment for food cravings, with a gold standard treatment strategy, Cognitive Behavioural Therapy (CBT), in addition to a control group.
Trial website
Trial related presentations / publications
Stapleton, PB, Sheldon, T., & Porter, B. (2012). Clinical Benefits of Emotional Freedom Techniques on Food Cravings at 12-months follow-up: A randomised controlled trial. Energy Psychology: Theory, Research, and Treatment, in press

Stapleton, P.B., Sheldon, T., Porter, B., & Whitty, J. 75% (2011). A Randomised Clinical Trial of a Meridian-Based Intervention for Food Cravings with Six Month Follow-up. Behaviour Change, 28 (1), 1-16.
Public notes

Contacts
Principal investigator
Name 34342 0
A/Prof Peta Stapleton
Address 34342 0
School Psychology, Bond University, University Dr, Robina QLD 4229
Country 34342 0
Australia
Phone 34342 0
+61 7 5595 2515
Fax 34342 0
Email 34342 0
[email protected]
Contact person for public queries
Name 17589 0
A/Prof Peta Stapleton
Address 17589 0
Faculty of Humanities and Social Sciences
Bond University
Robina Gold Coast QLD 4229
Country 17589 0
Australia
Phone 17589 0
+61 7 5595 2515
Fax 17589 0
+61 7 5595 2540
Email 17589 0
[email protected]
Contact person for scientific queries
Name 8517 0
A/Prof Peta Stapleton
Address 8517 0
Faculty of Humanities and Social Sciences
Bond University
Robina Gold Coast QLD 4229
Country 8517 0
Australia
Phone 8517 0
+61 7 5595 2515
Fax 8517 0
+61 7 5595 2540
Email 8517 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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