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Trial registered on ANZCTR


Registration number
ACTRN12620000078954
Ethics application status
Approved
Date submitted
9/01/2020
Date registered
30/01/2020
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
MANTRA Self-Help Feasibility Trial
Scientific title
Feasibility study of an early intervention self-help psychological treatment for adult anorexia nervosa in the primary care setting.
Secondary ID [1] 300129 0
University of Auckland Grant Code: 3718977
Universal Trial Number (UTN)
U1111-1240-5914
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 315656 0
Condition category
Condition code
Mental Health 313949 313949 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evidence-based early intervention treatment options for anorexia nervosa are scarce and inaccessible. This pilot project aims to assess the feasibility and early efficacy of a self-help workbook adaptation of the Maudsley outpatient treatment for adult anorexia nervosa (MANTRA), a specialist evidence-based psychological treatment for anorexia nervosa. The workbook adaptation is a published resource developed by the treatment authors at King's College London. The workbook will be given to participants by the research psychologist- being a self-help intervention, the participant will then work through the intervention themselves. The intervention will be targeted to mild and subthreshold/atypical cases of anorexia nervosa.

The treatment targets disordered eating symptomology together with each element of the cognitive-interpersonal maintenance model of anorexia nervosa (emotional dysregulation, perfectionism, response of close others, biases in neurocognitive profile and poor identity formation). The workbook includes both informational readings and pen and paper based exercises. Participants will be provided with a suggested reading schedule (1 small chapter per week, or 1 large chapter per fortnight - approximately 45-60 minutes per week) and complete the workbook independently over a 12-week period.

Uptake of the intervention (adherence) will be measured by participant self report at each of the questionnaire timepoints (what page they are up to). Additionally, participants will be asked to bring the workbook with them to the 12-week follow-up assessment appointment, where the researcher will take a count of the number of pen & paper based exercises completed (written space for these provided within the workbook).

Materials:
A Cognitive-Interpersonal Therapy Workbook for Treating Anorexia Nervosa: The Maudsley Model Hardcover (Schmidt, Startup & Treasure, 2018)
Intervention code [1] 316401 0
Treatment: Other
Intervention code [2] 316402 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322367 0
Eating disorder psychopathology assessed using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn and Beglin, 1994)
Timepoint [1] 322367 0
Baseline 4 weeks post commencement of intervention 8 weeks post commencement of intervention 12 weeks post commencement of intervention (completion of intervention) - Primary timepoint 6 weeks post completion of intervention (18 weeks post commencement of intervention) 12 weeks post completion of intervention (24 weeks post commencement of intervention)
Primary outcome [2] 322368 0
Eating disorder psychopathology assessed using the Eating Disorders Inventory-Third Edition (EDI-3; Garner, 2004)
Timepoint [2] 322368 0
Baseline 12 weeks post commencement of intervention/completion of intervention (Primary timepoint)
Primary outcome [3] 322369 0
Anorexia case status based on the Structured Clinical Interview for DSM-5 Diagnosis - Clinical Version (SCID-5-RV; First et al., 2015)
Timepoint [3] 322369 0
Baseline 12 weeks post commencement of intervention (completion of intervention) - Primary timepoint
Secondary outcome [1] 378231 0
Clinical impairment secondary to eating disorder assessed using the Clinical Impairment Assessment (CIA; Bohn and Fairburn, 2008)
Timepoint [1] 378231 0
Baseline 4 weeks post commencement of intervention 8 weeks post commencement of intervention 12 weeks post commencement of intervention (completion of intervention) - Primary timepoint 6 weeks post completion of intervention (18 weeks post commencement of intervention) 12 weeks post completion of intervention (24 weeks post commencement of intervention)
Secondary outcome [2] 378232 0
General psychopathology measured using the Depression Anxiety & Stress Scale (DASS-2; Brown et al., 1997)
Timepoint [2] 378232 0
Baseline 4 weeks post commencement of intervention 8 weeks post commencement of intervention 12 weeks post commencement of intervention (completion of intervention) - Primary timepoint 6 weeks post completion of intervention (18 weeks post commencement of intervention) 12 weeks post completion of intervention (24 weeks post commencement of intervention)
Secondary outcome [3] 378239 0
Emotion dysregulation assessed using the Difficulties in Emotional Recognition Scale - Short form (DERS-SF; Kaufaman et al., 2016)
Timepoint [3] 378239 0
Baseline 12 weeks post completion of intervention (24 weeks post commencement of intervention)
Secondary outcome [4] 378240 0
Motivation assessed using Autonomous and Controlled Motivation for Treatment Questionnaire (ACMTQ; Zuroff et al., 2007)
Timepoint [4] 378240 0
Baseline 12 weeks post completion of intervention (24 weeks post commencement of intervention)
Secondary outcome [5] 378241 0
Cognitive style (set shifting ability/attention to detail) assessed using the Detail and Flexibility Questionnaire (DFlex; Roberts et al., 2011)
Timepoint [5] 378241 0
Baseline 12 weeks post completion of intervention (24 weeks post commencement of intervention)
Secondary outcome [6] 378242 0
Participant qualitative evaluation regarding treatment credibility, acceptability and perceived effectiveness, assessed using an in house process evaluation questionnaire.
Timepoint [6] 378242 0
12 weeks post commencement of intervention (completion of intervention) - Primary timepoint
Secondary outcome [7] 378243 0
Workbook usage metrics in the form of the following questions: - Have you done any further reading or writing tasks in the workbook since we last saw you? (if yes) - What page are you currently up to in the workbook? (if yes) - How useful are you finding the workbook? 0 (not at all) - 10 (highly useful) - Have you engaged in any other treatment related to disordered eating, since you were discharged from the study? (if yes, please detail briefly i.e., what service or clinician).
Timepoint [7] 378243 0
6 weeks post completion of intervention (18 weeks post commencement of intervention) 12 weeks post completion of intervention (24 weeks post commencement of intervention)

Eligibility
Key inclusion criteria
Participants will be 18 years or older, medically stable, and meet criteria for mild or subthreshold anorexia nervosa, as per DSM-V (APA, 2013) criteria (Body mass index > 17.0 BMI).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with current or prior history of psychosis, current or prior specialist treatment for an eating disorder, or current suicidal ideation will not be entered into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed study is a feasibility trial, therefore a consecutive case series design has been selected to allow for maximum participation. A recruitment goal of 50 participants has been set.

A regression analysis will be used to investigate predictors of both treatment engagement and response (demographics, severity of anorexia nervosa/disordered eating psychopathology, co-morbidity, neurocognitive profile, and workbook usage).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 22194 0
New Zealand
State/province [1] 22194 0
Auckland

Funding & Sponsors
Funding source category [1] 304568 0
University
Name [1] 304568 0
University of Auckland
Country [1] 304568 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Office of Research Strategy and Integrity
THE CLOCKTOWER - Bldg 105
Level 1, Room 123
22 PRINCES ST
AUCKLAND CENTRAL
AUCKLAND 1010
New Zealand

Email address: [email protected]
Country
New Zealand
Secondary sponsor category [1] 304869 0
None
Name [1] 304869 0
Address [1] 304869 0
Country [1] 304869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304994 0
Health and Disability Ethics Committees
Ethics committee address [1] 304994 0
Ethics committee country [1] 304994 0
New Zealand
Date submitted for ethics approval [1] 304994 0
23/10/2019
Approval date [1] 304994 0
16/12/2019
Ethics approval number [1] 304994 0
19/STH/189

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

Contacts
Principal investigator
Name 98898 0
Dr Marion Roberts
Address 98898 0
PI: The University of Auckland Department of General Practice and Primary Health Care Faculty of Medical and Health Sciences Building 507, Level 3 85 Park Rd Grafton Auckland 1023
Country 98898 0
New Zealand
Phone 98898 0
+6421509085
Fax 98898 0
Email 98898 0
[email protected]
Contact person for public queries
Name 98899 0
Zara Godinovich
Address 98899 0
The University of Auckland Department of General Practice and Primary Health Care Faculty of Medical and Health Sciences Building 507, Level 3 85 Park Rd Grafton Auckland 1023
Country 98899 0
New Zealand
Phone 98899 0
+64211694768
Fax 98899 0
Email 98899 0
[email protected]
Contact person for scientific queries
Name 98900 0
Zara Godinovich
Address 98900 0
The University of Auckland Department of General Practice and Primary Health Care Faculty of Medical and Health Sciences Building 507, Ground Floor 85 Park Rd Grafton Auckland 1023
Country 98900 0
New Zealand
Phone 98900 0
+64211694768
Fax 98900 0
Email 98900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anonymised data may be shared with researchers who are directly collaborating with the research team. Whether data is shared and the type of data to be shared, will be at the lead investigator's discretion.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Shared anonymous data MAY include:
- Diagnostic and neuropsychological clinical assessment information
- Outcome metrics pertaining to psychopathology
- Qualitative feedback regarding the acceptability of the intervention
- Workbook usage metrics


What types of analyses could be done with individual participant data?
• Any purpose subject to approval by the lead investigator.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date determined.




To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvalal by Principal Investigator Dr Marion Roberts
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.