Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000274471
Ethics application status
Approved
Date submitted
21/02/2025
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Yoga for Eating Disorder Recovery
Scientific title
Examining yoga as an adjunct to evidence-based psychological therapies for eating disorder recovery
Secondary ID [1] 314137 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 336781 0
Condition category
Condition code
Mental Health 333270 333270 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Therapeutic Yoga Group Program
The group will include ED consumer and carer pairs. This group will be held at Deakin University Waterfront gym.
Up to 16 participants (8 consumers and 8 carers)
Before the group starts all ED consumer participants will be scheduled to meet with the Yoga Therapist, for a one-on-one one-hour consultation to complete screening and orientation and will discuss:
- Participant’s interest in trying a personal yoga practice, expectations, goals and suitability for the program
- The time of day they will practice, needs of their body and respiratory health (through observation, discussion and pulse reading)
- Past history of illness, current illness and medications.
- Weekly practice log and adverse event monitoring.
This session will be used to gather preliminary data and ensure that the yoga practice offered in group sessions is safe and suitable for each individual.
Participants will be provided with a yoga mat and attend 8 weekly group yoga sessions of 60 minutes each run by the yoga therapist. In addition to this, a mental health clinician will be present at each of the sessions to provide support as required. As the intervention is primarily aimed at supporting consumers through ED recovery, carer participants will attend the group sessions but will not be provided with a personalised home practice.
The goal of each group yoga practice is to give participants an experience of yoga as a discipline that can bring greater mindfulness to all that they do – breath, movement, attitude and relationship with self and others – ultimately providing an experience of creating space to observe the patterns of the mind without judgment.
The classes will be held in a community space close to Barwon Health Eating Disorder Services and will involve the following components:
- Gentle asana (postures) tailored to the capacity and needs of the group. Postures may be standing, lying or sitting.
- Breath awareness and implementation of pranayama techniques.
- Relaxation with a movement towards meditative focus. The goal at the end of each class will be to give participants a deep experience of relaxation and a direction towards focusing the mind.
Individualised yoga home practice
Participants will be encouraged to complete 15-30 minutes of home practice each day (at least three days per week) based on a personalised practice devised by the Yoga Therapist. The practice will involve simple movement and breathing techniques, with the aim of setting a new positive pattern for the participant and to create a commitment to doing something positive for body and mind and be suitable for clients engaging in ED treatment.
In the initial session, the yoga therapist will offer a home practice and go through this with participants. They will also explain the benefits of engaging in a home practice and how a weekly practice log can be used to support engagement.
Researchers will send participants an electronic weekly practice log which ask participants to document their practice. Firstly, it asks participants to reflect on why they chose to engage with the adjunctive therapeutic yoga program to gather information about acceptability. Using the electronic weekly yoga log, each week participants are asked to reflect on their practice over the previous week and quantify approximately how many days they completed their practice (including if they attended the group session), how long in duration the practice was, and how close the actual practice was to the individualised protocol that was developed for them.
Intervention code [1] 330617 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340842 0
Eating Disorder Symptoms
Timepoint [1] 340842 0
baseline and 8 weeks post intervention commencement
Primary outcome [2] 340990 0
Depression and Anxiety symptoms
Timepoint [2] 340990 0
baseline and 8 weeks post intervention commencement
Primary outcome [3] 340991 0
Perception of Body Image
Timepoint [3] 340991 0
baseline and 8 weeks post intervention commencement
Secondary outcome [1] 445218 0
Acceptability
Timepoint [1] 445218 0
end of treatment
Secondary outcome [2] 445688 0
Feasibility
Timepoint [2] 445688 0
end of treatment
Secondary outcome [3] 445689 0
Safety
Timepoint [3] 445689 0
end of treatment

Eligibility
Key inclusion criteria
Individuals being treated for an ED by Barwon Health EDs will be eligible to participate in the proposed study if they meet the inclusion criteria for adjunctive group programs.
The criteria for inclusion includes:
- Diagnosis of an eating disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), established via Clinical Interview based on the Structured Clinical Interview (SCID) for DSM-5 (American Psychological Association (APA), 2013).
- Are engaged in psychological therapy as part of their treatment plan
- Capacity to provide informed consent.
- Has a carer that is willing and able to engage in the research program with them
- Are aged between 12-25 years (as per service age range)
Individuals will not be eligible to participate in the trial if they are:
- Deemed to have a high risk of harming self or others.
- Medically unstable (to be determined by the treating consultant psychiatrist Dr. Adam De Chellis)
- Deemed unsuitable for group treatment at the time (e.g. presentation is too complex, or individual may not benefit due to personality style etc.). Screening procedures used by the clinic identify such individuals.
- Not available to participate in the group programs at the allocated times.
- Does not have a carer that is able to attend with them
- Experiencing a significant medical comorbidity, cognitive impairment, or substance dependence.
Substudy. Carer participant group: Inclusion and exclusion criteria:
- Eligible to attend group and agree to participate alongside the consumer
- Capacity to provide informed consent.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will not be eligible to participate in the trial if they are:
- Deemed to have a high risk of harming self or others.
- Medically unstable (to be determined by the treating consultant psychiatrist Dr. Adam De Chellis)
- Deemed unsuitable for group treatment at the time (e.g. presentation is too complex, or individual may not benefit due to personality style etc.). Screening procedures used by the clinic identify such individuals.
- Not available to participate in the group programs at the allocated times.
- Does not have a carer that is able to attend with them
- Experiencing a significant medical comorbidity, cognitive impairment, or substance 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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data will be entered into an SPSS database and 2-way repeated measures ANOVAs will be used to identify any change over time within and between groups, followed by appropriate post-hoc analyses in the case of identifying statistically significant differences.

A within-person analysis will be conducted for scores between baseline and post-intervention time points, for clinically significant change based on the Reliable Change Index (Jacobson & Truax, 1991). The RCI is a statistically validated approach used to assess clinically significant change in psychotherapy research. It adopts a liberal index of change, to assess for clinical efficacy in small sample sizes. The RCI uses instrument reliability scores to indicate whether an individual has demonstrated clinically significant improvement from their baseline pre-treatment assessment scores. Following the recommendations of Jacobson and Truax (1991), cut-off scores will be calculated for assessing the level of clinically significant change and scores on all outcome measures will be deemed reliably changed if they exceed the RCI.
The critical RCI value for the study is + or - 1.96 (this is the near-universal standard and corresponds to p = .05). The formula for calculating RCI is the participant score at a follow-up time point minus the same participant’s score at an earlier timepoint (e.g. 8-week post-intervention score minus baseline), divided by the standard error of the measurement. The advantage to using RCI is that the sample size is irrelevant for the analysis – each individual is their own “control”, and the population standard deviation is used to determine the clinical significance. Participant’s scores on each measure will be identified as one of the following four clinical indices: recovered, improved, unchanged, or deteriorated.
The proposed study and the substudy is a pilot feasibility and acceptability trial where the total sample is expected to be no more than N = 24 (n = 12 in each condition; 12 consumers and 12 carers). Sensitivity analyses are proposed for each of the quantitative outcomes measured at baseline and again at 8-weeks post-intervention. Assuming a two-tail test of within-subject differences and 80% power and alpha = .05, the study is powered to detect large changes over time (Hedges G = 0.88), and very large post-intervention between-groups differences (Hedges g = 1.2).
Quantitative demographic data will be analysed using descriptive statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/09/2024
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
26/09/2025
Actual
Sample size
Target
32
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43835 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 318543 0
University
Name [1] 318543 0
Deakin University
Country [1] 318543 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health Eating Disorder service
Address
Country
Australia
Secondary sponsor category [1] 320939 0
University
Name [1] 320939 0
Deakin University
Address [1] 320939 0
Country [1] 320939 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317143 0
Barwon Health HREC
Ethics committee address [1] 317143 0
Ethics committee country [1] 317143 0
Australia
Date submitted for ethics approval [1] 317143 0
09/07/2024
Approval date [1] 317143 0
09/07/2024
Ethics approval number [1] 317143 0
91526

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

Contacts
Principal investigator
Name 140146 0
A/Prof Melissa O'Shea
Address 140146 0
C/o 221 Burwood Hwy, Burwood VIC 3125, Deakin University, Burwood Campus, Victoria
Country 140146 0
Australia
Phone 140146 0
+61417507254
Fax 140146 0
Email 140146 0
[email protected]
Contact person for public queries
Name 140147 0
Jennifer O'Brien
Address 140147 0
c/o Deakin University Burwood Campus, 221 Burwood Hwy, Burwood VIC 3125
Country 140147 0
Australia
Phone 140147 0
+610405929410
Fax 140147 0
Email 140147 0
[email protected]
Contact person for scientific queries
Name 140148 0
Jennifer O'Brien
Address 140148 0
c/o Deakin University, Burwood Campus, 221 Burwood Hwy, Burwood VIC 3125
Country 140148 0
Australia
Phone 140148 0
+610405929410
Fax 140148 0
Email 140148 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: overall data only will be shared



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.