ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anorexia Nervosa

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Baseline, during treatment (weeks 10 and 20), at the end of treatment (week 30), and six months following treatment completion.

Secondary outcome [1]

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]

Baseline, during treatment (weeks 10 and 20), at the end of treatment (week 30), and six months following treatment completion.

Secondary outcome [2]

Objectively measured weight and height.

Timepoint [2]

Baseline, weekly during treatment, at the end of treatment (week 40), and six months following treatment completion.

Secondary outcome [3]

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]

Baseline, during treatment (weeks 10 and 20), at the end of treatment (week 30), and six months following treatment completion.

Secondary outcome [4]

Role impairment - as measured by additional one question assessing impact of eating disorder symptoms on participant's functionality.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Western Sydney University

Address [1]

Western Sydney University, Kingswood Campus - Second Avenue, Kingswood NSW 2747

Country [1]

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]

Individual

Name [1]

Dr Janet Conti

Address [1]

Western Sydney University, Kingswood Campus - Second Avenue, Kingswood NSW 2747

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Phillipa Hay

Address [1]

Western Sydney University, Kingswood Campus - Second Avenue, Kingswood NSW 2747

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney University Human Research Ethics Committee

Ethics committee address [1]

Western Sydney University

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/04/2022

Approval date [1]

31/05/2022

Ethics approval number [1]

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

Miss Lauren Elizabeth Heywood

Address

Western Sydney University Psychology Clinics, (Western Sydney University). Building O, Ground Floor, Kingswood Campus, Second Avenue, Kingswood, 2747, New South Wales (Australia) (Work)

Country

Australia

Phone

+61 430297348

Fax

[email protected]

Contact person for public queries

Name

Janet Conti

Address

Western Sydney University
School of Psychology
Bankstown Campus
Locked Bag 1797, Penrith NSW 2751

Country

Australia

Phone

+61419203443

Fax

[email protected]

Contact person for scientific queries

Name

Professor Phillipa Hay

Address

Western Sydney University School of Psychology Bankstown Campus Locked Bag 1797, Penrith NSW 2751

Country

Australia

Phone

+61412330428

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
15108	Study protocol	[email protected]
15109	Informed consent form	[email protected]
15110	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically