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Trial registered on ANZCTR


Trial ID
ACTRN12613000667718
Ethics application status
Approved
Date submitted
7/06/2013
Date registered
19/06/2013
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Group Treatment versus Individual Treatment of Depression in Adults: A Comparison of Cogitive Behavioural Therapy and Emotional Freedom Techniques?
Scientific title
For an adult with depression, does cognitive behavioural therapy or emotional freedom techniques have a more effective outcome in individual sessions or group treatment
Secondary ID [1] 282635 0
None
Universal Trial Number (UTN)
U1111-1144-0924
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 289330 0
Condition category
Condition code
Mental Health 289671 289671 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy is a psychotherapeutic approach which addresses dysfunctional emotions, maladaptive behaviors and cognitive processes, and contents through a number of goal-oriented, explicit systematic procedures. It will be provided in a group format for some participants, and individually for others (randomly allocated). Eight sessions will be offered, for 2 hours per session, once per week for 8 weeks.
Emotional Freedom Techniques is a form of counseling intervention that draws on various theories of alternative medicine including acupuncture, neuro-linguistic programming, energy medicine, and Thought Field Therapy. It will be provided in a group format for some participants, and individually for others (randomly allocated). Eight sessions will be offered, for 2 hours per session, once per week for 8 weeks. The total duration of the treatments will be 8 weeks. Followup will occur at 3-, 6- and 12-months post treatment.
Intervention code [1] 287301 0
Treatment: Other
Intervention code [2] 287363 0
Behaviour
Intervention code [3] 287364 0
Other interventions
Comparator / control treatment
Community sample of non-depressed adults. A call for community participants will be made through local online noticeboards (e.g. local government) and will require interested participants to anonymously complete assessment measurements for this purpose only. The self report questionnaires will be offered online, and no inducements will be offered. There will be no identifying information required.
Control group
Active

Outcomes
Primary outcome [1] 289758 0
Decrease in symptoms of depression. This will be done by using the Beck Depression Inventory II (Beck, Ward ,Mendelson Mock,& Erbaugh, 1961) and the Depression, Anxiety, Stress Scale 21 (Lovibond & Lovibond, 1993) - measure will also include the constructs of stress and anxiety which are common co-occuring symptoms with depression. Finally the Mini International Neuropsychiatric Interview (M.I.N.I.) - a short structured clinical interview which enables researchers to make diagnoses of psychiatric disorders according to DSM-IV or ICD-10 - will be used
Timepoint [1] 289758 0
end of 8-week treatment, and 3- and 6-month followup
Secondary outcome [1] 303185 0
decrease in co-morbid symptoms. The Depression, Anxiety, Stress Scale 21 (Lovibond & Lovibond, 1993) which includes the constructs of stress and anxiety which are common co-occuring symptoms with depression will be used, as well as the Mini International Neuropsychiatric Interview (M.I.N.I.) - a short structured clinical interview which enables researchers to make diagnoses of coexisting psychiatric disorders according to DSM-IV or ICD-10 - will be used
Timepoint [1] 303185 0
end of 8-week treatment program and 3- and 6-month timepoints

Eligibility
Key inclusion criteria
Adults over 18 years
Diagnosis of Depression as indicated by a structured clinical interview
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NO Diagnosis of Depression
Under age 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)
Subjects will respond to community announcements and voluntarily participate. Randomised treatment into the 2 conditions will occur using a randomisation program. Allocation concealment will occur through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
30 adults in each condition; EFT versus CBT versus community group control. IN order to achieve a large effect, a G*Power analysis indicated 30 people in each condition would suffice.
Analysis will examine pre versus post effects for each intervention to highlight any differences in self report and the clinical interview, and a repeated measures ANOVA/MANOVA will examine the effect of time on all the self report scores and the clinical interview. Due to the suggestion that EFT has lasting effects on other constructs (e.g. food cravings, PTSD), it is hypothesised that depression symptoms will reduce significantly with the EFT intervention and remain consistent at follow-up points. The CBT intervention as a gold standard may also experience decreases in depression symptoms but its comparison to EFT has not yet been studied. The differences between conditions will be examined at all follow-up points. It is expected that the control group condition will remain unaffected.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
study completed early
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)
QLD

Funding & Sponsors
Funding source category [1] 287414 0
Self funded/Unfunded
Name [1] 287414 0
Address [1] 287414 0
Country [1] 287414 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Department of Psychology, University Drive, Robina, QLD 4229
Country
Australia
Secondary sponsor category [1] 286160 0
None
Name [1] 286160 0
Address [1] 286160 0
Country [1] 286160 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289390 0
Bond University Research Human Ethics Committee
Ethics committee address [1] 289390 0
Bond University
University Drive
Robina QLD 4229
Ethics committee country [1] 289390 0
Australia
Date submitted for ethics approval [1] 289390 0
Approval date [1] 289390 0
20/02/2013
Ethics approval number [1] 289390 0
RO1518

Summary
Brief summary
Depression is one of the most common of all mental health problems and one in five people experience depression at some stage of their lives. A review by the National Institutes of Health found that some 20% of adolescents suffer from bouts of anxiety and depression before they reach adulthood. EFT (Emotional Freedom Techniques) has been shown to be efficacious for depression in a number of studies, including three randomized controlled trials. EFT contains elements of both exposure and cognitive therapy but to these established methods, adds the novel element of somatic stimulation. It has been found to have physiological mechanisms consistent with a lowering of the stress response, and a calming of the threat-assessment structures in the midbrain. These include a reduction in the body’s secretion of stress hormones such as cortisol, an increase in endogenous opioids, and a dampening of fear in the amygdala. This present study intends to compare the EFT treatment to a gold standard therapy for depression; Cognitive Behavioural Therapy (CBT), and a community control group. Understanding and improving the early intervention and treatment of depression and improving the health and quality of life for those with depression is critical to inform best practice.
Hypotheses will include:

1. The EFT group treatment conditions will have significantly decreased scores on depression measures from pre- to post treatment, and will be significantly improved compared to the community control group
2. It is expected the CBT group will also have significantly decreased scores on depression measures from pre- to post treatment, and will be significantly improved compared to the community control group, but that the EFT condition may be superior
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40598 0
A/Prof Peta Stapleton
Address 40598 0
Department of Psychology
Bond University
Robina QLD 4229
Country 40598 0
Australia
Phone 40598 0
+61755952515
Fax 40598 0
+61755952540
Email 40598 0
pstaplet@bond.edu.au
Contact person for public queries
Name 40599 0
A/Prof Peta Stapleton
Address 40599 0
Department of Psychology
Bond University
Robina QLD 4229
Country 40599 0
Australia
Phone 40599 0
+61755952515
Fax 40599 0
Email 40599 0
pstaplet@bond.edu.au
Contact person for scientific queries
Name 40600 0
A/Prof Peta Stapleton
Address 40600 0
Department of Psychology
Bond University
Robina QLD 4229
Country 40600 0
Australia
Phone 40600 0
+61755952515
Fax 40600 0
Email 40600 0
pstaplet@bond.edu.au