Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000764538
Ethics application status
Approved
Date submitted
16/05/2024
Date registered
21/06/2024
Date last updated
21/06/2024
Date data sharing statement initially provided
21/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Schema Therapy, Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED), and Treatment as Usual within the Public Hospital Setting for Individuals with Eating Disorders and Higher Weight
Scientific title
A Randomised Controlled Trial of Schema Therapy, HAPIFED, and Treatment as Usual within the Public Hospital Setting for Individuals with Eating Disorders and Higher Weight Assessing Future Recommendations of Psychological Treatment Modalities For Weight Management and Symptom Reduction
Secondary ID [1] 311818 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 333354 0
Eating Disorders 333355 0
Condition category
Condition code
Mental Health 330035 330035 0 0
Eating disorders
Public Health 330276 330276 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Modified Schema Therapy (ST) will be adapted for individuals with eating disorders and higher weight following the group manual set out by Simpson and Smith (2020). Therapy treatment will be groups of 10 participants run by a registered psychologist, and group will focus on the therapeutic alliance, psychoeducation/orientation to schema therapy, assessment and formulation, schema therapy strategies, chairwork, imagery rescripting, and understanding and linking unmet childhood needs to current-day challenges. Therapy sessions will have flexibility while also outlining key components of ST. For example, a session will begin with a review of the previous week (homework, schema/schema mode labelling, food monitor reviewing) and further exploration and elaboration of the various components of early maladaptive schemas (EMS), coping skills, etc. and its relation to disordered eating. Binge-eating will be classified as a self-soothing mode, and severe restriction as a perfectionistic over-controller mode. Homework will take between 30 minutes to 1 hour for participants within the week depending on tasks, and will involve activities such as worksheets (e.g. Schema Mode diary, identifying triggers, coping modes), a genogram outline of their family, mindfulness activities to do within the week, food diaries, etc. Monitoring adherence, depending on the task, will be done through assessing worksheet completion and/or within beginning sessions through reviewing the previous week’s task in group; each session will have an attendance list and associated checkoff for identifying participants who are in attendance. In terms of what sessions may look like, see below an example outline of session 1-4 work:
1. Sessions 1-4 General Themes/Goals
a. Explain that the overarching goal is for participants to change behavioural patterns while learning healthy ways of recognising and asking for help.
b. Group leaders model a Healthy Adult role, so as participant can gradually take this role on as group proceeds.
c. Sessions with focus on understanding the ST model and incorporating ED and other problematic symptoms and behaviours within a mode map conceptualisation. Behavioural goals are linked to ED’s are formulated, linking with their mode map
d. Beginning of each session will encourage participants to reflect on how they feel, giving options so that each participant can find a way to expressing their feelings (emotion word lists, facial emojis, emotion cards, emotion wheel)
e. Group safety will be cultivated through exercises such as ‘scarves’ activity and group therapy goals are established through psychoeducation of EMS and Modes; a significant amount of time is focused on psychoeducation and exploration of coping modes, and linking these to ED and behaviours
f. Measures introduced:
i. Schema Mode Eating Diary
ii. Schema Mode Tracker
iii. Understanding Coping Modes
iv. Mode Pie Charts
v. Schema Decision Flowchart
g. Schema Model
i. Everyone has some of these needs met and some unmet, and our job is to do the detective work to figure out the bits that have been positive and that are missing
ii. Card games, brick wall exercise
iii. Safety, stable base, predictability, love, nurturing, attention, acceptance and praise, empathy, guidance, protection, validation of feelings and needs
h. Linking Childhood Needs with EMS
i. Metaphors to introduce the concept of EMS: blind spots, emotional buttons, coloured cellophane lenses, coping modes as perpetuating factors
i. Exercises
i. Mode Mapping group exercise
ii. Mode spotting exercise
iii. Modes on a bus exercise
iv. Mode role plays
v. Detective work with pseudo-healthy modes
j. Homework with a general theme of behavioural pattern breaking tasks:
i. Genogram exercise (participants to identify possible origins of inner critic [parents modes, coping modes, and or schemas in previous generations to then discuss patterns of transgenerational schema/mode transmissions in a group])
ii. Schema Mode Diary





Arm 2: Modified 'Healthy APproach to weIght management and Food in Eating Disorders'
(HAPIFED) comes from Enhanced - Cognitive Behavioural Therapy (CBT-E) for eating disorders with integrating a program of behavioural weight loss therapy, and education about nutrition and exercise. HAPIFED emphasises eating according to hunger and satiety signals from the body, along with active behaviour change in between sessions. Therapy sessions will be groups of 10 participants run by a registered psychologist, and work in a conjunction between standard CBT-E protocol, nutritional counselling, healthy exercise and behavioural weight loss therapy. HAPIFED has been slightly modified in consultation with those who created the manual. Food dairies will be kept by participants throughout the week, and each session will have an attendance list and associated checkoff to identifying participants who are in attendance and for who completed diaries within group.

Treatment interventions will consist of 16 weekly 2-hour group sessions (approximately 4 months) with a single 6-month follow-up.
Intervention code [1] 328276 0
Treatment: Other
Intervention code [2] 328277 0
Behaviour
Intervention code [3] 328278 0
Lifestyle
Comparator / control treatment
Treatment as Usual: participants are under the standard care by the endocrinologist.
All patients consulted in diabetes centre if they have any indication of mental health issues impacting the diabetes care will undergo Diabetes Distress Scale (DDS), Problem Areas in Diabetes (PAID) and Patient Health Questionnaire-4 (PHQ-4) questions under Health Outcomes and Patient Experience (HOPE) platform. Consultant endocrinologist with review the results and refer them to general practitioner (GP) requesting them to refer to clinical psychologist as we do not have clinical psychologist as part of multidisciplinary team (MDT). This is largely having the impact in our cohort of patients as they get missed in the system to be referred to the psychologist since they would have exhausted the 5 free Enhanced Primary Care (EPC) and they are not socioeconomically able to afford to consult the private psychologist. Unable to access the clinical psychologist lead to suboptimal control of glycaemic control.
Control group
Active

Outcomes
Primary outcome [1] 338433 0
To evaluate the efficacy and effectiveness of Schema Therapy for weight loss compared to treatment as usual and other evidence-based psychological treatment namely HAPIFED.
Timepoint [1] 338433 0
Baseline/pre-treatment, 1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week, 8th week, 9th week, 10th week, 11th week, 12th week, 13th week, 14th week, 15th week, 16th week post-commencement - completion of treatment (primary timepoint), 6 month post-completion follow-up
Secondary outcome [1] 433338 0
Participant mood
Timepoint [1] 433338 0
Baseline/pre-treatment, 16 week post-commencement - completion of treatment, 6 month post-completion follow up
Secondary outcome [2] 435834 0
Participant eating behaviours, eating disorder symptoms
Timepoint [2] 435834 0
Baseline/pre-treatment, 16 week post-commencement - completion of treatment, 6 month post-completion follow up
Secondary outcome [3] 435835 0
Participant Early Maladaptive Schemas
Timepoint [3] 435835 0
Baseline/pre-treatment, 16 week post-commencement - completion of treatment, 6 month post-completion follow up
Secondary outcome [4] 435836 0
Participant schema modes
Timepoint [4] 435836 0
Baseline/pre-treatment, 16 week post-commencement - completion of treatment, 6 month post-completion follow up
Secondary outcome [5] 435922 0
Participant emotional regulation
Timepoint [5] 435922 0
Baseline/pre-treatment, 16 week post-commencement - completion of treatment, 6 month post-completion follow up
Secondary outcome [6] 435924 0
Participant trauma symptoms
Timepoint [6] 435924 0
Baseline/pre-treatment, 16 week post-commencement - completion of treatment, 6 month post-completion follow up

Eligibility
Key inclusion criteria
The inclusion and exclusion criteria is based upon Schema Therapy’s recommended ‘suitable for treatment’ candidate (Smith, 2020).
1. Individuals will be currently attending the Fairfield Obesity and Diabetes Clinics and will be identified as having higher weight (BMI greater than or equal to 30 kg/m2)
2. Inclusion criteria:
a. Male or female aged 18 years or older;
b. Are able to read, write and communicate in English, willing and able to provide written informed consent;
c. A BMI of greater than or equal to 30 kg/m2 which includes individuals both in the overweight and obesity ranges;
d. Willing to undertake the 16 weekly group sessions (approximately 4 months) with a 6-month follow-up, and to attend sessions regularly (i.e., no more than 5 missed sessions over the course of the program)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Pregnant or breastfeeding, or having a desire to become pregnant during the course of the study;
b. Undergone bariatric surgery or intragastric balloon insertion in the 24 months prior to screening as weight loss can continue up to 24 months post-procedure;
c. Diagnosis of a condition, or use of a medical treatment, that interferences with appetite regulation;
d. Severe psychoactive substance dependence, have a diagnosis of Bipolar 1 Disorder, and/or Schizophrenia;
e. Cognitive impairment, or diagnosed with Intellectual (Development) Disability Disorder, mild, moderate or severe;
f. Have previously undertaken a trial of ST within the last year;
g. Regular substance use that could interfere with treatment that is assessed by the clinician;
h. Presenting problems are situational and do not seem to be related to a life pattern (schema);
i. Are in crisis in any area of life

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)
central randomisation by phone/fax/computer
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2024
Actual
Date of last participant enrolment
Anticipated
22/01/2025
Actual
Date of last data collection
Anticipated
26/11/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26321 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 42295 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 316154 0
University
Name [1] 316154 0
Western Sydney University
Country [1] 316154 0
Australia
Primary sponsor type
Hospital
Name
Fairfield Hospital
Address
Country
Australia
Secondary sponsor category [1] 318333 0
University
Name [1] 318333 0
Western Sydney University
Address [1] 318333 0
Country [1] 318333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314983 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314983 0
Ethics committee country [1] 314983 0
Australia
Date submitted for ethics approval [1] 314983 0
29/01/2024
Approval date [1] 314983 0
27/03/2024
Ethics approval number [1] 314983 0
2023/ETH02684

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

Contacts
Principal investigator
Name 133318 0
Dr Manimegalai Manoharan
Address 133318 0
Fairfield Hospital P.O. Box 5 FAIRFIELD NSW 1851
Country 133318 0
Australia
Phone 133318 0
+61423379924
Fax 133318 0
Email 133318 0
[email protected]
Contact person for public queries
Name 133319 0
Nicole Renee Anderson
Address 133319 0
Western Sydney University Bankstown City Campus, 74 Rickard Rd, Bankstown NSW 2200
Country 133319 0
Australia
Phone 133319 0
+61434740637
Fax 133319 0
Email 133319 0
[email protected]
Contact person for scientific queries
Name 133320 0
Nicole Renee Anderson
Address 133320 0
Western Sydney University Bankstown City Campus, 74 Rickard Rd, Bankstown NSW 2200
Country 133320 0
Australia
Phone 133320 0
+61434740637
Fax 133320 0
Email 133320 0
[email protected]

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?

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.