Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000229077
Ethics application status
Approved
Date submitted
16/03/2010
Date registered
18/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A case series evaluation of the Maudsley Model for Treatment of Adults with Anorexia nervosa (MANTRA)
Scientific title
A case series evaluation of the Maudsley Model for Treatment of Adults with Anorexia nervosa (MANTRA) using body mass index and global Eating Disorder Examination as indicators of good outcome
Secondary ID [1] 1510 0
None
Universal Trial Number (UTN)
U1111-1114-4246
Trial acronym
MANTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anorexia nervosa 256974 0
Condition category
Condition code
Mental Health 257118 257118 0 0
Eating disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Eligibility criteria for the study included meeting the diagnostic criteria for anorexia nervosa (AN) with the exception that body mass index (BMI) was less than 19 as previously adopted in other treatment studies and amenorrhea was not required. Additional eligibility criteria required that person was medically stable as assessed by their general practitioner, and was aged 16 years and over. There was no exclusion based on BMI or comorbidity in order to make the study as inclusive as possible. The study was advertised to eating disorder service providers in South Australia, as well as the consumer support organisation and people were entered into the trial between 2005 and 2007. Data were collected at baseline, sessions 5 and 10, and at post-treatment, 3-month and 12-month follow-up. The outpatient therapy for AN was based on MANTRA, the treatment developed by Professors Ulrike Schmidt and Janet Treasure, designed specifically to treat AN and formulated from the cognitive-interpersonal maintenance model. MANTRA aims to tackle maintaining factors related to perfectionism and obsessive-compulsive personality traits, avoidance, pro-anorectic beliefs, and the responses of close others. The modularised treatment that has resulted from this model maintains a focus on specific changes required in eating and weight within a motivational interviewing and cognitive behavioural therapy framework, including individualised case conceptualisation, in addition to summary letters from the therapist to the patient. Due to its modularized nature, it results in a targeted treatment of AN that is matched to the clinical symptoms, personality traits and neuropsychological profile of participants, an approach that has been successfully used in people with addictions.
Intervention code [1] 256151 0
Treatment: Other
Intervention code [2] 256166 0
Other interventions
Comparator / control treatment
case series design, no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258013 0
Body mass index >= 18.5 and global Eating Disorder Examination score within one Standard Deviation (SD) of the community norm
Timepoint [1] 258013 0
post-treatment, 3-month follow-up, 12-month follow-up
Secondary outcome [1] 263578 0
motivation to change behaviour and increase weight using the self-report questionnare, the Anorexia Nervosa Stages of Change Questionnaire
Timepoint [1] 263578 0
post-treatment, 3-month follow-up, 12-month follow-up

Eligibility
Key inclusion criteria
Body mass index <19, meeting all other criteria for anorexia nervosa with exception of amenorrhea
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
medically unstable at baseline

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256656 0
Charities/Societies/Foundations
Name [1] 256656 0
Rotary
Country [1] 256656 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 255944 0
None
Name [1] 255944 0
Address [1] 255944 0
Country [1] 255944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258678 0
Flinders University Clinical Research Ethics Committee
Ethics committee address [1] 258678 0
Flinders University
GPO Box 2100, Adelaide, SA, 5001
Ethics committee country [1] 258678 0
Australia
Date submitted for ethics approval [1] 258678 0
Approval date [1] 258678 0
Ethics approval number [1] 258678 0

Summary
Brief summary
There were two main aims of the current study. The first was to examine outcome in a new outpatient therapy for AN, MANTRA, in order to decide whether these pilot data was supportive of such a therapy being further investigated in more robust designs such as a randomized controlled trials. The second aim was to investigate the moderating impact of randomization to an extra therapeutic writing module, in order to make conclusions about whether such an addition to therapy was worth pursuing in future development of this new therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30941 0
Address 30941 0
Country 30941 0
Phone 30941 0
Fax 30941 0
Email 30941 0
Contact person for public queries
Name 14188 0
Tracey Wade
Address 14188 0
School of Psychology
Flinders University
GPO Box 2100
Adelade, SA, 5001
Country 14188 0
Australia
Phone 14188 0
+61-8-8201-3736
Fax 14188 0
Email 14188 0
[email protected]
Contact person for scientific queries
Name 5116 0
Tracey Wade
Address 5116 0
School of Psychology
Flinders University
GPO Box 2100
Adelade, SA, 5001
Country 5116 0
Australia
Phone 5116 0
+61-8-8201-3736
Fax 5116 0
Email 5116 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
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