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Trial registered on ANZCTR


Registration number
ACTRN12611000725965
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
12/07/2011
Date last updated
29/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial of three new treatments for anorexia nervosa in adults
Scientific title
A randomized controlled trial of three new treatments for anorexia nervosa in adults
Secondary ID [1] 262607 0
None.
Universal Trial Number (UTN)
Trial acronym
SWAN - Strong Without Anorexia Nervosa Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anorexia nervosa 257070 0
eating disorder not otherwise specified 257071 0
Condition category
Condition code
Mental Health 257227 257227 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive between 25 and 40 outpatient, individual treatment sessions with a registered Psychologist, each lasting 50 minutes duration. The number of sessions will be determined by the participant's starting Body Mass Index. Sessions will be spaced over a 10 month period.

Participants will be randomly allocated to one of three psychological treatments: Maudsley Model Anorexia Nervosa Treatment for Adults (MANTRA), Enhanced Cognitive Behaviour Therapy (CBT-E), or Specific Supportive Clinical Management (SSCM). All are based on established treatment manuals and guidelines, and all psychologists have been trained in the treatments by the treatment developers.

MANTRA and CBT-E are hypothesised to result in greater improvements in symptomatology. MANTRA uses a motivation-focused approach and incorporates work on thinking styles, social and emotional functioning, pro-anorexic beliefs, and interpersonal relationships. CBT-E focuses on the thoughts and beliefs that maintain the eating disorder, and incorporates mood regulation work.
Intervention code [1] 256238 0
Treatment: Other
Intervention code [2] 256239 0
Behaviour
Comparator / control treatment
Specific Supportive Clinical Management (SSCM) is included as a control treatment, but is nonetheless an active and evidence-supported treatment for anorexia nervosa.

As above, the treatment would involve 25 to 40 outpatient sessions with a Psychologist over a 10 month period. The treatment includes psychoeducational material and uses an established therapist treatment guide.

SSCM is a patient-focused treatment that has a central aim of assisting patients to re-learn to eat normally, whilst also attending to salient issues that patients bring to treatment.
Control group
Active

Outcomes
Primary outcome [1] 258115 0
A dimensional measure of change in Body Mass Index (BMI).
Timepoint [1] 258115 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Primary outcome [2] 297527 0
A dimensional measure of change in the severity of eating disorder features (as measured by the Global Eating Disorder Examination score) .
Timepoint [2] 297527 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [1] 263746 0
Categorical measures of remission as defined by (1) having a score on the global subscale of the Eating Disorder Examination (EDE) that is less than one standard deviation above Australian community norms (i.e., below 1.81); (2) a body mass index (BMI) greater than or equal to 18.5kg/m2, the WHO cut-off for healthy weight and (3) having both a Global EDE score < 1.81 and a BMI > 18.5 as well as the absence of eating disorder behaviours (binge eating, purging).
Timepoint [1] 263746 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [2] 263748 0
Self-esteem (Rosenberg self-esteem inventory)
Timepoint [2] 263748 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [3] 263750 0
Perfectionism (The Concern over Mistakes and Personal Standards scales from the Multidimensional Perfectionism Scale).
Timepoint [3] 263750 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [4] 263751 0
Obsessionality (the 12-item just right sub-scale of the Vancouver Obsessional Compulsive Inventory).
Timepoint [4] 263751 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [5] 263752 0
Avoidance (the 8-item Emotional Approach Coping scale)
Timepoint [5] 263752 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [6] 263753 0
Mood intolerance (items from the Screening Test for Co-morbid Personality Disorders (STCPD) - a shortened version of the revised Personality Diagnostic Questionnaire. )
Timepoint [6] 263753 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [7] 263754 0
Pro-anorexic beliefs (the 30-item Decisional Balance Scale for AN)
Timepoint [7] 263754 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [8] 263755 0
Interpersonal functioning (The Inventory of Interpersonal Problems, a 48-item self-report measure designed to assess distress arising from interpersonal sources)
Timepoint [8] 263755 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [9] 263756 0
The response of close others (the Level of Expressed Emotion Questionnaire).
Timepoint [9] 263756 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [10] 263757 0
General Psychiatric symptoms (the short form of the Depression Anxiety and Stress Scales (DASS)).
Timepoint [10] 263757 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [11] 263758 0
Quality of life (the 12-item Short-Form Health Survey (SF-12))
Timepoint [11] 263758 0
pre-treatment (T1), mid-treatment (T2), post-treatment (T3), six months post-treatment (T4), one year post-treatment (T5)
Secondary outcome [12] 263759 0
Patients' ratings of the suitability and likely effectiveness of the treatment being offered will be assessed using standard visual analogue scales.
Timepoint [12] 263759 0
mid-treatment (T3)

Eligibility
Key inclusion criteria
aged at least 17 years, and fulfil our research criteria for AN phenotype which are: meeting criteria A and B of DSM-IV for AN (i.e., refusal to maintain normal body weight and intense fear of gaining weight) and BMI<18.5 kg/m2.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current manic episode or psychosis; current alcohol or substance abuse or dependence; significant current medical or neurological illness (including seizure disorder) which impacts on their weight, with the exception of nutrition-related alterations; pregnancy, BMI less than 14kg/m2 , or any other circumstances (e.g., not being available for the full course of treatment) that make it inappropriate for them to enter the trial.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
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)
NSW,SA,WA

Funding & Sponsors
Funding source category [1] 256743 0
Government body
Name [1] 256743 0
NHMRC
Address [1] 256743 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 256743 0
Australia
Funding source category [2] 293012 0
Charities/Societies/Foundations
Name [2] 293012 0
McCusker Charitable Foundation
Address [2] 293012 0
McCusker Charitable Foundation
PO Box Z5110
Perth WA 6831
Country [2] 293012 0
Australia
Primary sponsor type
Individual
Name
Assoc. Prof. Susan Byrne
Address
University of Western Australia, School of Psychology, Stirling Highway, Crawley, 6010 , W.A.
Country
Australia
Secondary sponsor category [1] 266469 0
None
Name [1] 266469 0
Address [1] 266469 0
Country [1] 266469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258749 0
UWA Human Research Ethic Committee
Ethics committee address [1] 258749 0
University of Western Australia, Stirling Highway, Crawley, W.A. 6009
Ethics committee country [1] 258749 0
Australia
Date submitted for ethics approval [1] 258749 0
Approval date [1] 258749 0
29/01/2010
Ethics approval number [1] 258749 0
RA/4/1/2645

Summary
Brief summary
The Strong Without Anorexia Nervosa (SWAN) Study is evaluating three psychological treatments for anorexia nervosa and atypical anorexia nervosa in adults. It is funded by the National Health and Medical Research Council of Australia and will be one of the largest study of its kind worldwide.

Men and women aged 17 years and older with anorexia nervosa or atypical anorexia nervosa, who are able to attend appointments in Perth, Adelaide or Sydney, are eligible to take part.

Participation is free and the Study is running from 2010 to 2015. It is hoped that 120 individuals will participate across the three states
Trial website
http://www.psychology.uwa.edu.au/research/swan-study
Trial related presentations / publications
Andony LJ, Tay E, Allen KL, Wade TD, Hay P, Touyz S, McIntosh V, Treasure J, Schmidt U, Fairburn CG, Erceg-Hurn D, Fursland A, Crosby R, Byrne SM. Therapist adherence in the Strong Without Anorexia Nervosa (SWAN) Study: A randomised controlled trial of three treatments for anorexia nervosa in adults. Int J Eat Dis 2015; 48 (8): 1170-1175.
Public notes

Contacts
Principal investigator
Name 31001 0
A/Prof Susan Byrne
Address 31001 0
University of Western Australia
School of Psychology M304
UWA
35 Stirling Hwy
Crawley WA 6009
Country 31001 0
Australia
Phone 31001 0
+61 8 64888079
Fax 31001 0
Email 31001 0
sue.byrne@uwa.edu.au
Contact person for public queries
Name 14248 0
Dr Dr Karina Allen
Address 14248 0
School of Psychology
The University of Western Australia
35 Stirling Hwy
Crawley WA Australia 6009
Country 14248 0
Australia
Phone 14248 0
+61 8 6488 7428
Fax 14248 0
Email 14248 0
karina.allen@uwa.edu.au
Contact person for scientific queries
Name 5176 0
Dr Dr Karina Allen
Address 5176 0
School of Psychology
The University of Western Australia
35 Stirling Hwy
Crawley WA Australia 6009
Country 5176 0
Australia
Phone 5176 0
+61 8 6488 7428
Fax 5176 0
Email 5176 0
karina.allen@uwa.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