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Trial registered on ANZCTR


Registration number
ACTRN12622000620729
Ethics application status
Approved
Date submitted
28/03/2022
Date registered
27/04/2022
Date last updated
2/11/2023
Date data sharing statement initially provided
27/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Narrative therapy Intervention for Anorexia Nervosa: A Feasibility Study.
Scientific title
Narrative Therapy Intervention for Anorexia Nervosa: A Feasibility Study.
Secondary ID [1] 306446 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 325286 0
Condition category
Condition code
Mental Health 322686 322686 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention will consist of a feasibility study for a manualised narrative therapy treatment based on a guidebook developed by Dr Janet Conti that is informed on the work of Michael White and David Epston.

The research will use a mixed methods approach, with both quantitative and qualitative methods in the form of a single case, repeated measures design. Participants will consist of 5 individuals with a previous diagnosis of Anorexia Nervosa (AN) and a Body Mass Index (BMI) of between 14 and 19. Exclusion criteria will include a diagnosis of psychosis or bipolar disorder, and/or a high level of suicide risk or medical compromise, and/or current active substance use disorder with dependence. Participants will receive intervention on a weekly basis (approximately one hour sessions) for approximately thirty to forty weeks/sessions. The treatment will be conducted at the Western Sydney University psychology rooms or via Zoom telehealth technology. Intervention will be carried out concurrently by the principal researcher, who is a Clinical Psychologist who has had training in narrative therapy interventions, and her principal supervisor who is a Clinical Psychologist and endorsed supervisor who specialises in the treatment of eating disorders, including with narrative therapy. Supervision will also be provided by Professor Phillipa Hay who is Chair of Mental Health, School of Medicine at Western Sydney University. Professor Hay is a highly experienced psychiatrist in the treatment of anorexia nervosa.

Treatment outcome will be assessed quantitatively using standardised measures at the beginning, during, and at the end of treatment. Qualitative analysis will be conducted of the transcripts of therapy sessions and participant interviews by using narrative and discourse/discursive methods to inductively generate key themes and analyse participant experiences and identify shifts within therapy.
Intervention code [1] 322878 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330481 0
Eating disorder symptoms, as assessed by a composite of the Eating Disorder Questionnaire (EDE-Q) and The Eating Disorder Questionnaire Short Form (EDE-QS) by Fairburn & Beglin (2008).
Timepoint [1] 330481 0
Baseline, during treatment (EDE-Q at weeks 10 and 20, EDE-QS at weekly intervals), at the end of treatment (week 30), and six months following treatment completion.
Primary outcome [2] 330984 0
The Health-Related Quality of Life 12-Item Short Form Survey (SF-12) will be used to assess current impairment of eating disorder symptoms on daily functioning.
Timepoint [2] 330984 0
Baseline, during treatment (weeks 10 and 20), at the end of treatment (week 30), and six months following treatment completion.
Secondary outcome [1] 408353 0
Primary Outcome.

The Hospital Anxiety and Depression scale (HADS) (Zigmond & Snaith, 1983) will be used to assess severity and frequency of symptoms of depression and anxiety.
Timepoint [1] 408353 0
Baseline, during treatment (weeks 10 and 20), at the end of treatment (week 30), and six months following treatment completion.
Secondary outcome [2] 428503 0
Objectively measured weight and height.
Timepoint [2] 428503 0
Baseline, weekly during treatment, at the end of treatment (week 40), and six months following treatment completion.
Secondary outcome [3] 428504 0
The Anorexia Stages of Change Questionnaire (ANSOCQ) (Reiger, 2002) will be used to measure participants' attitudes towards their eating disorder symptoms, and views about treatment.
Timepoint [3] 428504 0
Baseline, during treatment (weeks 10 and 20), at the end of treatment (week 30), and six months following treatment completion.
Secondary outcome [4] 428505 0
Role impairment - as measured by additional one question assessing impact of eating disorder symptoms on participant's functionality.
Timepoint [4] 428505 0
Baseline, weekly during treatment, at the end of treatment (week 40), and six months following treatment completion.

Eligibility
Key inclusion criteria
Diagnosis of Anorexia Nervosa, BMI between 14-19, regular medical appointments/clearance from their GP to engage in this outpatient treatment intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of psychosis or Bipolar Disorder, high level of suicide risk and/or medical compromise, current active substance use disorder with dependence.

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
Single case, repeated measures design.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The single case, repeated measures design was determined to be appropriate as it has scope to test the effectiveness of the intervention with a small number of participants (5) and is a method frequently used in applied psychology contexts. Statistical analyses will consist of operations to determine whether changes in treatment outcomes are statistically significant (e.g., t-tests, repeated measures ANOVA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
16/03/2023
Date of last participant enrolment
Anticipated
22/12/2023
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
8
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310796 0
University
Name [1] 310796 0
Western Sydney University
Country [1] 310796 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University, Kingswood Campus - Second Avenue, Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 312038 0
Individual
Name [1] 312038 0
Dr Janet Conti
Address [1] 312038 0
Western Sydney University, Kingswood Campus - Second Avenue, Kingswood NSW 2747
Country [1] 312038 0
Australia
Other collaborator category [1] 282865 0
Individual
Name [1] 282865 0
Professor Phillipa Hay
Address [1] 282865 0
Western Sydney University, Kingswood Campus - Second Avenue, Kingswood NSW 2747
Country [1] 282865 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310366 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 310366 0
Western Sydney University
Ethics committee country [1] 310366 0
Australia
Date submitted for ethics approval [1] 310366 0
30/04/2022
Approval date [1] 310366 0
31/05/2022
Ethics approval number [1] 310366 0

Summary
Brief summary
This research involves participants with a diagnosis of anorexia nervosa receiving narrative therapy intervention (as per a manualised treatment developed by Dr Janet Conti) on a weekly basis for approximately 30-40 sessions. The treatment will be facilitated at the Western Sydney University Psychology psychology rooms or over telehealth programs if required.

Upon individuals expressing their interest in the intervention, they will be screened according to the inclusion/exclusion criteria and contacted via e-mail to advise of their acceptance to the intervention, request any further information, and to provide recruitment documentation and informed consent forms. Potential participants will have approximately 2-3 weeks to consider participation and confirm their desire to proceed. During these 2-3 weeks, they will be asked if they agree to consent to completion of baseline quantitative measures. Following this, clearance will be obtained from the participant's GP and contact made via e-mail or telephone prior to, at the outset, during, and at the end point of treatment.

Participants will receive the intervention free of charge. They will be asked to complete surveys and questionnaires at the beginning, middle and end points of treatment. They will be provided with a two-page summary of the findings at the end of the intervention. Additionally, participants will be actively involved in member-checking the analysis of session and treatment outcomes to ensure that their feedback, experiences and perspectives have been accurately represented in the final paper.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117402 0
Miss Lauren Elizabeth Heywood
Address 117402 0
Western Sydney University Psychology Clinics, (Western Sydney University). Building O, Ground Floor, Kingswood Campus, Second Avenue, Kingswood, 2747, New South Wales (Australia) (Work)
Country 117402 0
Australia
Phone 117402 0
+61 430297348
Fax 117402 0
Email 117402 0
18080070@student.westernsydney.edu.au
Contact person for public queries
Name 117403 0
Dr Janet Conti
Address 117403 0
Western Sydney University
School of Psychology
Bankstown Campus
Locked Bag 1797, Penrith NSW 2751
Country 117403 0
Australia
Phone 117403 0
+61419203443
Fax 117403 0
Email 117403 0
j.conti@westernsydney.edu.au
Contact person for scientific queries
Name 117404 0
Prof Professor Phillipa Hay
Address 117404 0
Western Sydney University School of Psychology Bankstown Campus Locked Bag 1797, Penrith NSW 2751
Country 117404 0
Australia
Phone 117404 0
+61412330428
Fax 117404 0
Email 117404 0
p.hay@westernsydney.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15108Study protocol  18080070@student.westernsydney.edu.au
15109Informed consent form  18080070@student.westernsydney.edu.au
15110Ethical approval  18080070@student.westernsydney.edu.au



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.