Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000795796
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
16/07/2013
Date last updated
19/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing a new clinical resource for anorexia nervosa: Stories of recovery from anorexia
Scientific title
Assessing a new clinical resource for anorexia nervosa: Stories of recovery from anorexia
Secondary ID [1] 282826 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 289609 0
Condition category
Condition code
Mental Health 289948 289948 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After eligibility is assessed, participants will complete baseline measurements. Depending on randomisation, participants will then either receive the intervention or receive nothing as part of a wait-list control group. The intervention for this study is the reading stories of successful recovery from anorexia nervosa. The narratives are approximately 4,000 to 5,000 words each. Participants will be asked to read five narratives of recovery over a two week period. After two weeks, all participants (both those in intervention and wait-list control group) will repeat the measures completed at baseline. The study will conclude for those in the intervention group. The wait-list control group will then receive the intervention. Two weeks later they will complete the measures again.
Intervention code [1] 287516 0
Lifestyle
Intervention code [2] 287517 0
Behaviour
Comparator / control treatment
The control group will be a wait-list control. After baseline measures are completed the wait-list control group will receive no intervention for the following two weeks. After two weeks they will complete measures again and will then receive the intervention. Two weeks later, they will complete measures a final time.
Control group
Active

Outcomes
Primary outcome [1] 290002 0
Primary Outcome 1: increases in motivation as measured by scores on questionnaire designed for study purposes entitled 'Predicting Intentions to Recover from Anorexia Nervosa'
Timepoint [1] 290002 0
Time point: Baseline and 2 weeks after intervention commencement
Secondary outcome [1] 303759 0
Secondary outcome: Increases in motivation as measured by Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ; Rieger et al 2000).
Timepoint [1] 303759 0
Secondary time point: Baseline and at 2 weeks after intervention commencement

Eligibility
Key inclusion criteria
Patients with all forms of clinically significant AN-type eating disorders will be recruited. This is to test whether the resource is effective across all clinically significant forms of AN and not merely the strict diagnostic criteria for AN, which many patients fall outside of. Participants will therefore meet the following inclusion criteria: be aged at least 18 years, and fulfil research criteria for AN phenotype, which are: (i) meeting criteria A and B of DSM-IV for AN (i.e. refusal to maintain a normal body weight and intense fear of weight gain); and (ii) BMI less than 20 kg/m2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age 18 or not proficient in English

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
This is a novel study and therefore difficult to determine power, however, most RCTs in AN have recruited between 50-75 participants. The literature on RCTs involving psychotherapy for AN has suggested that 40 participants per cell is needed to ensure sufficient power (Agras & Robinson, 2010). In line with this, and to account for attrition rates, we aim to recruit 100 participants for the current study.

In comparing the intervention versus control conditions Analysis of Variance (ANOVA) procedures will be used. Participants who received the intervention will be compared to the control group. Analysis will involve 2(time) X 2(group) ANOVAS to compare difference in level of motivation between the intervention and control groups post intervention. There are two DVs of interest including (i) intention to recover and (ii) stage of change. Baseline measurements and other covariates will be controlled for. Statistical adjustments for multiple comparisons will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5191 0
United States of America
State/province [1] 5191 0
Country [2] 5192 0
United Kingdom
State/province [2] 5192 0

Funding & Sponsors
Funding source category [1] 287612 0
University
Name [1] 287612 0
The University of Sydney
Country [1] 287612 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Sydney
NSW, 2006
Country
Australia
Secondary sponsor category [1] 286356 0
University
Name [1] 286356 0
The University of Sydney
Address [1] 286356 0
The University of Sydney
Sydney
NSW, 2006
Country [1] 286356 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289583 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 289583 0
Ethics committee country [1] 289583 0
Australia
Date submitted for ethics approval [1] 289583 0
Approval date [1] 289583 0
10/07/2013
Ethics approval number [1] 289583 0
2012/1530

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41426 0
Dr Paul Rhodes
Address 41426 0
Mackie Building
School of Psychology
The University of Sydney
NSW, 2006
Country 41426 0
Australia
Phone 41426 0
+61 2 9351 6708
Fax 41426 0
Email 41426 0
[email protected]
Contact person for public queries
Name 41427 0
Lisa Dawson
Address 41427 0
Griffith Taylor Building (A19)
School of Psychology
The University of Sydney
NSW, 2006
Country 41427 0
Australia
Phone 41427 0
+61 404056753
Fax 41427 0
Email 41427 0
[email protected]
Contact person for scientific queries
Name 41428 0
Lisa Dawson
Address 41428 0
Griffith Taylor Building (A19)
School of Psychology
The University of Sydney
NSW, 2006
Country 41428 0
Australia
Phone 41428 0
+61 404056753
Fax 41428 0
Email 41428 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.