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Trial registered on ANZCTR


Registration number
ACTRN12610000968077
Ethics application status
Approved
Date submitted
20/10/2010
Date registered
10/11/2010
Date last updated
20/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an Online Cognitive Behavioural Therapy Program for Bulimia Nervosa: A Randomised Controlled Trial with Therapist Assistance and Automated Emails
Scientific title
Evaluation of an Online Cognitive Behavioural Therapy Program for Bulimia Nervosa: A Randomised Controlled Trial with Therapist Assistance and Automated Emails
Secondary ID [1] 252787 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa 258288 0
Condition category
Condition code
Mental Health 258484 258484 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online cognitive behavioural program for bulimia nervosa - called Bulimia Online. The program includes 12 modules which participants are given 12 weeks to complete. It is estimated that participants will engage in approximately 1 hour of online reading and approximately 1-2 hours of offline activities per week. Modules cover topics including food monitoring, regular eating, meal planning, mindfulness, self-esteem, thoughts and behaviours related to shape and weight, perfectionism, assertiveness and relapse prevention.

Participants will be randomly assigned to one of three conditions; (1) BO with therapist assistance (BO-TA); (2) BO automated self help (BO-ASH); or (3) a wait-list control (WLC) group. Participants in the BO-TA condition will be allocated an online therapist (who will be a fully or provisionally registered psychologist) who will email them once per week and whom they can email as often as they wish. Participants in the BO-ASH condition will be sent a weekly automated email reminding them to complete the modules and encouraging them to think about important points from each module. Participants in the WLC condition will have access to the BO-ASH condition after three months.
Intervention code [1] 257468 0
Behaviour
Intervention code [2] 257584 0
Treatment: Other
Comparator / control treatment
Wait list control group will be offered to participate in Bulimia Online (automated self-help) after 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 259315 0
Clinical severity will be measured using the Eating Disorder Examination Questionnaire
Timepoint [1] 259315 0
Pre (prior to random allocation
Post (immediately after completion of the program)
Follow-up (3 months after completion of the program)
Secondary outcome [1] 265763 0
Depression will be measured using the Depression Anxiety Stress Scale (DASS-21)
Timepoint [1] 265763 0
Pre, post and 3 month follow-up
Secondary outcome [2] 266065 0
Clinical impairment related to eating disorder features will be measured using the Clinical Impairment Assessment Questionnaire
Timepoint [2] 266065 0
Pre, post and 3 month follow-up
Secondary outcome [3] 266066 0
Self stigma of seeking psychological help will be measured by the Self-stigma of Seeking Help Scale
Timepoint [3] 266066 0
Pre, post and 3 month follow-up
Secondary outcome [4] 266067 0
Health locus of control will be measured using the Multidimensional Health Locus of Control form C
Timepoint [4] 266067 0
Pre, post and 3 month follow-up
Secondary outcome [5] 266068 0
Emotional, psychological and social well-being will be measured using the Mental Health Continuum Short Form
Timepoint [5] 266068 0
Pre, post and 3 month follow-up
Secondary outcome [6] 266069 0
Treatment credibility will be measured using the Treatment Credibility Scale
Timepoint [6] 266069 0
Pre, post and 3 month follow-up
Secondary outcome [7] 266070 0
Body attitudes will be measured using the Ben-Tovim Walker Body Attitudes Questionnaire
Timepoint [7] 266070 0
Pre, post and 3 month follow-up

Eligibility
Key inclusion criteria
BMI of 18 or above; Australian resident; regular internet access; if taking psychotropic medication, to be included in the study participants must have been taking a constant dose for the past 3 months and must agree to maintain that dose for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary diagnosis of depression, PTSD or substance dependence; currently undertaking CBT for bulimia; high risk of suicide

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)
“Potential participants can choose to visit the Anxiety Online website (www.anxietyonline.org.au) and will need to read and consent to the standard Anxiety Online Terms and Conditions of Use to undertake the online psychological assessment (e-PASS). If they receive a diagnosis of bulimia nervosa and meet other inclusion criteria , they will be offered the opportunity to participate in the current study evaluating Bulimia Online. These potentially interested participants will then be presented with the Bulimia Online RCT explanatory statement and then asked to the provide their informed consent online. Participants will also need to provide the name and contact details of their general practitioner (GP). An individual’s GP would only be contacted in the event that they are believed to be at risk of harm to themselves or others. After providing consent, the participant’s e-PASS assessment will be manually reviewed to ensure that they meet inclusion and exclusion criteria. Participants who have endorsed an item on the e-PASS assessment indicating that they have recently experienced suicidal thoughts will be sent an email requesting that they complete a brief online risk assessment so that investigators can obtain more detailed information about the risk of suicide or self harm. Based on their responses to this assessment, those individuals who indicate that they are at high risk of suicide or self harm will be offered alternative treatment options via a telephone call from the student investigator. Those individuals whose risk level is deemed to be low will be randomly allocated to one of two active conditions (who will receive immediate access to Bulimia Online) or a waitlist control condition (who will have access to Bulimia Online after three months).” To ensure that allocation of participants is masked an independent researcher will consult a random numbers table to inform the researcher in charge of allocation which condition the participant is assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking 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
Active, not 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)

Funding & Sponsors
Funding source category [1] 257742 0
University
Name [1] 257742 0
Swinburne University
Address [1] 257742 0
H29, PO Box 218
Hawthorn VIC 3122
Country [1] 257742 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
H29, PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 257110 0
None
Name [1] 257110 0
Address [1] 257110 0
Country [1] 257110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259795 0
Swinburne Human Research Ethics Committee
Ethics committee address [1] 259795 0
Swinburne University of Technology
P O Box 218
HAWTHORN VIC 3122
Ethics committee country [1] 259795 0
Australia
Date submitted for ethics approval [1] 259795 0
28/02/2010
Approval date [1] 259795 0
05/03/2010
Ethics approval number [1] 259795 0
2009/276

Summary
Brief summary
A randomised controlled trial (RCT) will be used to evaluate the effectiveness of the BO program; an internet-based CBT program for BN. Participants will be randomly assigned to one of three conditions; (1) BO with therapist assistance (BO-TA); (2) BO automated self help (BO-ASH); or (3) a wait-list control (WLC) group. Participants in the BO-TA condition will be allocated an online therapist (who will be a fully or provisionally registered psychologist) who will email them once per week and whom they can email as often as they wish. Participants in the BO-ASH condition will be sent a weekly automated email reminding them to complete the modules and encouraging them to think about important points from each module. Participants in the WLC condition will have access to the BO-ASH condition after three months.

Participants randomised to the intervention conditions (BO-TA and BO-ASH) will complete online assessments at pre, post- and 3-month follow-up. Participants randomised to the waitlist control condition will complete online assessments at pre and post waitlist, as well as post and 3- month follow-up BO.

This study is a repeated measures design with three time points. We will employ multi-level modelling to allow for the comparison of the two BO programs and waitlist control condition in terms of changes in clinical diagnosis, BN specific symptomatology, general psychological functioning and quality of life, drop-out, and program engagement while controlling for and testing for any important participant variables such as age, gender and education. In addition, pre-, post- and follow-up variables will be subjected to correlational and multiple regression analyses to determine significant correlates of treatment adherence and attrition and potential predictors and discriminators of successful intervention outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31715 0
Address 31715 0
Country 31715 0
Phone 31715 0
Fax 31715 0
Email 31715 0
Contact person for public queries
Name 14962 0
Britt Klein
Address 14962 0
Director - National eTherapy Centre
Swinburne University of Technology
H29, P O Box 218
HAWTHORN VIC 3122
Country 14962 0
Australia
Phone 14962 0
+61 3 9214 8851
Fax 14962 0
Email 14962 0
bklein@swin.edu.au
Contact person for scientific queries
Name 5890 0
Britt Klein
Address 5890 0
Director - National eTherapy Centre
Swinburne University of Technology
P O Box 218
HAWTHORN VIC 3122
Country 5890 0
Australia
Phone 5890 0
+61 3 9214 8851
Fax 5890 0
Email 5890 0
bklein@swin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary