Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000860561
Ethics application status
Approved
Date submitted
27/07/2015
Date registered
18/08/2015
Date last updated
18/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Carers of people with anorexia nervosa: an evaluation of an online web-based skills intervention with and without clinician support
Scientific title
Carers of people with anorexia nervosa: an evaluation of the feasibility and usefulness of an online web-based skills intervention with and without clinician support
Secondary ID [1] 287153 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anorexia nervosa 295712 0
Condition category
Condition code
Mental Health 295992 295992 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Overcoming Anorexia Online (OAO), 7 modules plus hard copies of an additional two workbooks, providing them with information on how to take care of their own well-being (Workbook 8) and additional information on treatments and resources (Workbook 9). Module 1 gives key information regarding symptoms and diagnosis and discusses myths and misconceptions.Carers are introduced to the systemic cognitive-behavioral approach underpinning the intervention. They are introduced to the 5-area approach to conceptualizing and understanding problems and the process of CBT. Module 2 focuses on helping carers to understand why people value their anorexia nervosa (AN) and the implications this has for their willingness to engage with treatment and for change, using the ‘Stages of Change’ model. It focuses on developing the skills needed to communicate effectively with a person who is ambivalent about change by teaching carers the principles of motivational interviewing. Module 3 addresses how AN affects families and uses the 5 -area approach to help carers to identify and understand how unhelpful behaviors and avoidance can result from difficult situations by teaching them to formulate their own and their loved one’s difficulties and to assess how their own reactions relate to and impact on each other by acting to ‘‘keep the AN going.’’ It also teaches people how to develop a plan to ‘break out’’ of these inter-relating vicious cycles in a manner that is appropriate to the developmental and illness stage of the sufferer. Module 4 concerns how to talk about meal support with the sufferer, make a collaborative plan to address this need and suggests tools and techniques for giving meal support. Module 5 is about risk and prognosis, including understanding and talking about medical risk with the sufferer and how to prepare for an appointment with health professionals. Module 6 tackles understanding the function of difficult behaviors such as bingeing, purging, or self-harm and helping to support the person to stop these. Module 7 This deals with relapse prevention—helping carers to identify the risk of relapse, helping the sufferer to maintain improvement, avoiding entering the cycle of reassurance, dealing with set-backs and looking for support. Modules are offered weekly over a 7-week period. Adherence was monitored via logging on to the online modules. Clinical guidance was provided by email or telephone by a Masters level trainee psychologist once a week. The intervention was only offered to carers and the each module took around 1 hour to complete.
Intervention code [1] 292423 0
Behaviour
Comparator / control treatment
Random allocation to receiving additional clinician guidance (OAO-G) or no guidance (OAO-NoG) i.e., the no guidance group received OAO only.
Control group
Active

Outcomes
Primary outcome [1] 295663 0
level of expressed emotion measured with the 38-item Level of Expressed Emotion Scale completed by carers
Timepoint [1] 295663 0
baseline, post-intervention (within one week of program completion), 3-month follow-up
Secondary outcome [1] 316153 0
AN sufferers completed the Level of Expressed Emotion scale to record their perception of their carer’s EE.
Timepoint [1] 316153 0
baseline, post-intervention (within one week of program completion), 3-month follow-up
Secondary outcome [2] 316473 0
General Health Questionnaire, completed by carer
Timepoint [2] 316473 0
baseline, post-intervention (within one week of program completion), 3-month follow-up
Secondary outcome [3] 316474 0
Medical Outcome Study Short Form Scale, completed by carer
Timepoint [3] 316474 0
baseline, post-intervention (within one week of program completion), 3-month follow-up
Secondary outcome [4] 316475 0
Depression Anxiety Stress Scales, completed by carer
Timepoint [4] 316475 0
baseline, post-intervention (within one week of program completion), 3-month follow-up
Secondary outcome [5] 316476 0
25-item Eating Disorder Symptom Impact Scale, completed by carer
Timepoint [5] 316476 0
baseline, post-intervention (within one week of program completion), 3-month follow-up
Secondary outcome [6] 316477 0
Experience of Care Giving Inventory assessing both the positive and negative experiences of caregiving
Timepoint [6] 316477 0
baseline, post-intervention (within one week of program completion), 3-month follow-up

Eligibility
Key inclusion criteria
Carers spoke English fluently and were presently caring for a person experiencing anorexia nervosa. The family member with AN was invited to complete questionnaires on expressed emotion at each time point.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2010
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
24/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291751 0
Self funded/Unfunded
Name [1] 291751 0
Country [1] 291751 0
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 290393 0
None
Name [1] 290393 0
Address [1] 290393 0
Country [1] 290393 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293242 0
Flinders University Social and Behavioural Ethics Committee
Ethics committee address [1] 293242 0
Ethics committee country [1] 293242 0
Australia
Date submitted for ethics approval [1] 293242 0
Approval date [1] 293242 0
25/09/2010
Ethics approval number [1] 293242 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 530 530 0 0
/AnzctrAttachments/368999-Hoyle_carers_2013.pdf

Contacts
Principal investigator
Name 59054 0
Prof Tracey Wade
Address 59054 0
school of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 59054 0
Australia
Phone 59054 0
+61 8 82013736
Fax 59054 0
Email 59054 0
[email protected]
Contact person for public queries
Name 59055 0
Tracey Wade
Address 59055 0
school of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 59055 0
Australia
Phone 59055 0
+61 8 82013736
Fax 59055 0
Email 59055 0
[email protected]
Contact person for scientific queries
Name 59056 0
Tracey Wade
Address 59056 0
school of Psychology
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 59056 0
Australia
Phone 59056 0
+61 8 82013736
Fax 59056 0
Email 59056 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

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

Documents added automatically
No additional documents have been identified.