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Trial registered on ANZCTR


Registration number
ACTRN12615000788572
Ethics application status
Approved
Date submitted
2/07/2015
Date registered
30/07/2015
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does collaborative case conceptualisation enhance engagement and outcome in the treatment of anorexia nervosa?
Scientific title
Does collaborative case conceptualisation enhance engagement and outcome in the treatment of anorexia nervosa?
Secondary ID [1] 286701 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 295057 0
Low body weight eating disorder 295608 0
Condition category
Condition code
Mental Health 295308 295308 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Collaborative Case Conceptualisation (CCC) is designed as a prelude to traditional treatment with the aim of improving treatment motivation and engagement and therefore treatment outcome. It targets proposed anorexia nervosa (restricting type) maintaining factors namely obsessive-compulsive and perfectionistic behaviours and cognitions, avoidant behaviours and cognitions, positive beliefs about anorexia nervosa and responses of close others.

CCC is done jointly with the patient and uses motivational techniques and an understanding of learning principles with a focus on the maintaining factors of AN. The collaborative assessment is conducted across 3 sessions (one session per week, each lasting approximately 1 hour) by psychology interns (post-graduate provisional psychologists). The assessments are largely focussed on identifying biopsychosocial maintaining factors for the disorder and during the assessment the therapist is constantly listening for examples of these factors. Using psychoeducation and socratic questioning, a shared understanding is developed in regards to the eating disorder and what keeps it going. This process then informs with the development of collaborative treatment goals. At completion patients will be provided with a formulation letter summarising the joint understanding of the maintaining factors of the disorder. A log of attendance at sessions will be used to monitor adherence.
Intervention code [1] 291848 0
Behaviour
Intervention code [2] 292335 0
Treatment: Other
Comparator / control treatment
Assessment as Usual (AAU) is ‘usual care assessment’ and will include a mental status examination, assessment of clinical history (including family corroboration), and a physical examination. The assessment is conducted across 3 sessions (one session per week, each lasting approximately 1 hour) by psychology interns (post-graduate provisional psychologists). At completion patients will be provided with a diagnosis, traditional formulation and management plan. A log of attendance at sessions will be used to monitor adherence.
Control group
Active

Outcomes
Primary outcome [1] 295045 0
Body mass index
Timepoint [1] 295045 0
12 months post randomisation
Primary outcome [2] 295233 0
Eating disorder symptomatology as assessed by the Eating Disorders Examination Questionnaire
Timepoint [2] 295233 0
12 months post randomisation
Secondary outcome [1] 314665 0
Body mass index
Timepoint [1] 314665 0
Post-treatment
Secondary outcome [2] 314666 0
Eating disorder symptomatology as assessed by the Eating Disorders Examination Questionnaire
Timepoint [2] 314666 0
Post-treatment
Secondary outcome [3] 315131 0
Disordered eating psychopathology as assessed by the Eating Disorder Inventory-3
Timepoint [3] 315131 0
Post-treatment
Secondary outcome [4] 315132 0
Disordered eating psychopathology as assessed by the Eating Disorder Inventory-3
Timepoint [4] 315132 0
12 months post randomisation
Secondary outcome [5] 315133 0
Clinical impairment as assessed by the Clinical Impairment Assessment 3.0
Timepoint [5] 315133 0
Post-treatment
Secondary outcome [6] 315134 0
Clinical impairment as assessed by the Clinical Impairment Assessment 3.0
Timepoint [6] 315134 0
12 months post randomisation
Secondary outcome [7] 315135 0
Depression, anxiety and stress symptoms as assessed using the Depression Anxiety and Stress Scale-21
Timepoint [7] 315135 0
Post-treatment
Secondary outcome [8] 315136 0
Depression, anxiety and stress symptoms as assessed using the Depression Anxiety and Stress Scale-21
Timepoint [8] 315136 0
12 months post randomisation
Secondary outcome [9] 315137 0
Obsessive compulsive traits as assessed using the Obsessive Compulsive Inventory
Timepoint [9] 315137 0
Post-treatment
Secondary outcome [10] 315138 0
Obsessive compulsive traits as assessed using the Obsessive Compulsive Inventory
Timepoint [10] 315138 0
12 months post randomisation
Secondary outcome [11] 315139 0
Cognitive flexibility as assessed using the The Cognitive Flexibility Scale
Timepoint [11] 315139 0
Post-treatment
Secondary outcome [12] 315140 0
Cognitive flexibility as assessed using the The Cognitive Flexibility Scale
Timepoint [12] 315140 0
12 months post randomisation
Secondary outcome [13] 315141 0
Emotion regulation as assessed using the The Emotion Regulation Questionnaire
Timepoint [13] 315141 0
Post-treatment
Secondary outcome [14] 315142 0
Emotion regulation as assessed using the The Emotion Regulation Questionnaire
Timepoint [14] 315142 0
12 months post randomisation
Secondary outcome [15] 315143 0
Motivation as assessed using visual analog scales
Timepoint [15] 315143 0
Post-treatment
Secondary outcome [16] 315144 0
Motivation as assessed using visual analog scales
Timepoint [16] 315144 0
12 months post randomisation
Secondary outcome [17] 315145 0
Communication within the family as assessed using the Family Problem Solving Communication Index
Timepoint [17] 315145 0
Post-treatment
Secondary outcome [18] 315146 0
Communication within the family as assessed using the Family Problem Solving Communication Index
Timepoint [18] 315146 0
12 months post randomisation
Secondary outcome [19] 315147 0
Quality of life as assessed using the Assessment of Quality of Life
Timepoint [19] 315147 0
Post-treatment
Secondary outcome [20] 315148 0
Quality of life as assessed using the Assessment of Quality of Life
Timepoint [20] 315148 0
12 months post randomisation
Secondary outcome [21] 315149 0
Eating disorders quality of life as assessed using the Eating Disorders Quality of Life Scale
Timepoint [21] 315149 0
Post-treatment
Secondary outcome [22] 315150 0
Eating disorders quality of life as assessed using the Eating Disorders Quality of Life Scale
Timepoint [22] 315150 0
12 months post randomisation
Secondary outcome [23] 315151 0
Motivation for change as assessed using the Pros and Cons of Anorexia Nervosa Questionnaire- Revised and The Readiness and Motivation Questionnaire
Timepoint [23] 315151 0
Post-treatment
Secondary outcome [24] 315152 0
Motivation for change as assessed using the Pros and Cons of Anorexia Nervosa Questionnaire- Revised and The Readiness and Motivation Questionnaire
Timepoint [24] 315152 0
12 months post randomisation
Secondary outcome [25] 315153 0
Health care utilisation as assessed using the Treatment Usage Form
Timepoint [25] 315153 0
Post-treatment
Secondary outcome [26] 315154 0
Health care utilisation as assessed using the Treatment Usage Form
Timepoint [26] 315154 0
12 months post randomisation
Secondary outcome [27] 315155 0
Treatment acceptability assessed using visual analogue scales
Timepoint [27] 315155 0
Post-treatment
Secondary outcome [28] 315852 0
Social support as assessed using visual analog scales
Timepoint [28] 315852 0
Post treatment
Secondary outcome [29] 315853 0
Social support as assessed using visual analog scales
Timepoint [29] 315853 0
12 months post randomisation

Eligibility
Key inclusion criteria
Inclusion criteria will include; (1) current diagnosis of anorexia nervosa or unspecified/other specified eating disorder with low body weight (BMI less than 18.5kg/m2), (2) agreement to attend the evaluation and assessment sessions and the medical assessment, (3) ability to read and write in English, and (4) ability to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include; (1) BMI less than 14.5kg/m2, (2) requiring inpatient treatment, (3) actively suicidal, and/or (4) severe mental or physical illness or disability likely to impact on participation (e.g., diabetes, psychosis, substance use, cognitive impairment).

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)
Allocation will be concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation) will be used to generate the sequence in which subjects will be randomised.
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
The target sample size for the current study has been determined after considering both power analyses and feasibility of recruitment. Based on McIntosh et al. (2005) a 62.5% retention rate was conservatively estimated (it is expected that this rate will be higher given the current study involves 3 rather than 20 session). The power analysis was performed using G*Power. Using the effect size found in the McIntosh study (w= .90) as an estimated treatment effect for the current study, a total sample size of 20 participants was needed to achieve 81% power to detect a strong effect, at alpha = 0.05. As such, we aim to recruit 32 participants in the current study, to account for the anticipated attrition rate based on McIntosh.

Completer and intention to treat analyses will be conducted. Descriptive statistics, effect sizes and measures of precision will be reported and linear mixed-effects models for repeated measures over time will be used to examine outcomes. Reliable clinically significant change (Evans,Margison, &Barkham, 1998). will be calculated to provide an indication of the meaningfulness of the change achieved by individual participants Exploratory analyses of the impact of the proposed mediators on intervention outcome will be conducted using regression procedures (Baron & Kenny, 1986). Cost effectiveness will be assessed by estimating the costs and outcomes of each intervention using a within trial analysis (Glick, Doshi, Sonnad, &Polsky, 2007) and benefits will be measured using the outcome variables. The relationship between costs and outcomes, incremental cost effectiveness ratios and cost utility analysis will be reported.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/02/2015
Actual
20/02/2015
Date of last participant enrolment
Anticipated
30/06/2016
Actual
16/10/2015
Date of last data collection
Anticipated
Actual
18/12/2015
Sample size
Target
32
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3873 0
The Melbourne Clinic - Richmond
Recruitment hospital [2] 3874 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 3875 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 291414 0
University
Name [1] 291414 0
Australian Catholic University
Country [1] 291414 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 290090 0
Other Collaborative groups
Name [1] 290090 0
The Body Image & Eating Disorders Treatment & Recovery Service (Austin Health and St Vincent’s Melbourne)
Address [1] 290090 0
Rear 104 Studley Park Rd Kew Victoria 3101
Country [1] 290090 0
Australia
Other collaborator category [1] 278492 0
Hospital
Name [1] 278492 0
The Melbourne Clinic (Richmond)
Address [1] 278492 0
130 Church St, Richmond VIC 3121
Country [1] 278492 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292963 0
Australian Catholic University Human Research Ethcs Committee
Ethics committee address [1] 292963 0
Research Services
Australian Catholic University
Melbourne Campus
Locked Bag 4115
Fitzroy Vic 3065
Ethics committee country [1] 292963 0
Australia
Date submitted for ethics approval [1] 292963 0
Approval date [1] 292963 0
26/08/2014
Ethics approval number [1] 292963 0
2014 242V
Ethics committee name [2] 292964 0
St Vincent's Hospital (Melbourne) Human Research Ethcs Committee
Ethics committee address [2] 292964 0
Research Governance Unit
St Vincent's Hospital
PO Box 2900
Fitzroy Victoria 3065
Ethics committee country [2] 292964 0
Australia
Date submitted for ethics approval [2] 292964 0
Approval date [2] 292964 0
14/07/2014
Ethics approval number [2] 292964 0
HREC-A 046/14
Ethics committee name [3] 293118 0
Melbourne Clinic Human Research Ethics Committee
Ethics committee address [3] 293118 0
130 Church Street
Richmond VIC 3121
Ethics committee country [3] 293118 0
Australia
Date submitted for ethics approval [3] 293118 0
Approval date [3] 293118 0
10/06/2015
Ethics approval number [3] 293118 0
Project 260

Summary
Brief summary
This study will examine the efficacy of collaborative case conceptualization (CCC), a novel assessment approach (based on the Maudsley Model of Treatment for Adults with Anorexia Nervosa), compared to standard assessment as usual (AAU) for adults with Anorexia Nervosa. It is hypothesized that, relative to usual care, CCC will result in improvements in general psychopathology and quality of life 12-month follow-up. This study will also examine post-assessment outcomes and potential mediators of the effect of CCC (i.e., obsessive-compulsive and perfectionistic behaviours and cognitions, avoidant behaviours and cognitions, pro-anoretic beliefs and responses of close others).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57238 0
A/Prof Leah Brennan
Address 57238 0
School of Psychology
Australian Catholic University
115 Victoria Parade/Locked Bag 4115
Fitzroy Victoria 3065
Country 57238 0
Australia
Phone 57238 0
+61 3 9953 3662
Fax 57238 0
Email 57238 0
[email protected]
Contact person for public queries
Name 57239 0
Leah Brennan
Address 57239 0
School of Psychology
Australian Catholic University
115 Victoria Parade/Locked Bag 4115
Fitzroy Victoria 3065
Country 57239 0
Australia
Phone 57239 0
+61 3 9953 3662
Fax 57239 0
Email 57239 0
[email protected]
Contact person for scientific queries
Name 57240 0
Leah Brennan
Address 57240 0
School of Psychology
Australian Catholic University
115 Victoria Parade/Locked Bag 4115
Fitzroy Victoria 3065
Country 57240 0
Australia
Phone 57240 0
+61 3 9953 3662
Fax 57240 0
Email 57240 0
[email protected]

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No Supporting Document Provided



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