Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000282583
Ethics application status
Approved
Date submitted
16/02/2024
Date registered
20/03/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Building Positive Body Image in Chronic Illness
Scientific title
Preliminary Evaluation of a Cognitive Behavioural Group Program Targeting Body Image in Adults with a Chronic Illness: A Pilot Study
Secondary ID [1] 311399 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body image 332684 0
Condition category
Condition code
Cardiovascular 329390 329390 0 0
Coronary heart disease
Cancer 329391 329391 0 0
Any cancer
Inflammatory and Immune System 329392 329392 0 0
Rheumatoid arthritis
Musculoskeletal 329393 329393 0 0
Osteoarthritis
Musculoskeletal 329394 329394 0 0
Osteoporosis
Respiratory 329395 329395 0 0
Asthma
Respiratory 329396 329396 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 329397 329397 0 0
Diabetes
Renal and Urogenital 329398 329398 0 0
Kidney disease
Mental Health 329812 329812 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Cognitive behavioural therapy targeting body image in adults with a chronic illness (Empower: Body Acceptance Skills program)

Materials: The Empower: Body Acceptance Skills program was designed to target negative body image, positive body image and well-being in adults with a chronic illness. Each participant is provided with a Participant Handbook to accompany participation in the group program. This resource comprises an overview of the program aims, approach, and expectations for participation, as well as support services that might be of interest. Furthermore, each session includes psychoeducation and skills training materials related to focal topics so that participants can review these in their own time, as well as activities completed in session and for homework. These materials have been developed by psychologists based on evidence-based cognitive behavioural therapy programs and resources for body image enhancement, which have been adapted for the chronic illness context to address specific body image concerns reported in this population by the research team. The program also includes additional positive body image techniques which have been tested in this population. The structure and adaptation of these programs and techniques, and the resulting Participant Handbook and materials employed in this study, were developed specifically by the research team in a research project which employed co-production processes with adults with a chronic illness to tailor the program content and materials, which lead to the development of the Empower: Body Acceptance Skills through a project supported by the ACT Government under the ACT Health Promotion Grants Program 2021-2023. Session delivery also includes use of visual aids in the form of powerpoint slides to assist in provision of psychoeducation and skills training.

Procedures: Individuals interested in participating in Empower: Body Acceptance Skills contact the ANU Psychology Clinic to express their interest. As a program delivered within the ANU Psychology Clinic, implementation is undertaken in line with policies and procedures of the service. Individuals who express their interest in the program undertake a telephone pre-screening and a face-to-face assessment session to determine suitability for the group program. During this assessment process participants complete paperwork required for clients of this service, and are informed that management of their chronic illness remains with their GP and other healthcare providers. Eligible participants are then allocated to the next available group program delivery, with those who do not meet eligibility criteria provided with alternative referral options. Participants are invited to take part in the voluntary research evaluation of the group program in the first session, and can choose to complete the group but not the research evaluation as this is an open pilot trial program evaluation in a service setting. Session attendance is documented each session, with those unable to attend provided with opportunities to ask questions about materials missed.

Content: The cognitive behavioural therapy program (named Empower: Body Acceptance Skills) is delivered in a collaborative and supportive manner, with each session comprising a review of previous content or homework tasks, psychoeducation on concepts and skills training related to each session topic, and activities designed to facilitate discussion and reflection on participant experiences, and training in psychological skills to assist in body image enhancement. Facilitators encourage participants to ask questions and contribute to discussion throughout, ensuring that all have an opportunity to participate to the degree they are comfortable. Across sessions, two fictional characters are used as an alternative mode to demonstrate skills and concepts, and a tracking sheet is utilised to monitor body image experiences and progressively document the implementation of skills to manage barriers to positive body image throughout the program. Each session has associated take-home practice activities, amounting to approximately 30 to 60 minutes per week. A brief description of the content in each session is provided below:

Session 1:
Program information, aims, ground rules, confidentiality
Defining body image and its importance in chronic illness
Introducing cognitive behaviour therapy
Identifying values to prepare for body image work
H/W Program goals

Session 2:
Cognitive behavioural model of body image
Development of body image, and your body image journey
Investing in body care behaviours guided by values
H/W Body image self-monitoring and body care

Session 3:
Shifting our focus on the body
Body functionality and appreciation
H/W Body image self-monitoring and functional appreciation

Session 4:
Identifying unhelpful body-related thoughts
Addressing and reframing unhelpful body-related thoughts
H/W Identifying and addressing unhelpful body-related thoughts

Session 5:
Body image threats and chronic illness
Self-compassion and body image
H/W Practicing self-compassion

Session 6:
Identifying unhelpful body image behaviours
Addressing avoidance by approaching the body
H/W Action plans to approach the body well

Session 7:
Building a body supportive environment
Challenging ideals and assertive communication
H/W Supporting a body positive environment

Session 8:
Fostering body protection
Bringing it all together to maintain progress
H/W Relapse prevention, taking care of your body for life

Who: The program is delivered by AHPRA-registered provisional psychologists who are undertaking placement in the ANU Psychology Clinic as part of postgraduate study in clinical psychology under the supervision of AHPRA-registered Psychologists and Clinical Psychologists. The program is implemented in accordance with a Facilitator Handbook.

Mode of delivery: The program is delivered face-to-face either in-person or via telehealth in a small group comprising up to eight participants per group.

Number of times: The program comprises a total of eight sessions of up to 90 minutes duration each. During sessions in which evaluation measures are completed, the sessions are scheduled for two hours. It is planned that Sessions 1-4 will be delivered at weekly intervals, and Sessions 5-8 at fortnightly intervals.

Location: The program is delivered by the ANU Psychology Clinic on-site or via telehealth at the ANU.

Personalisation of the group program occurs to the extent that activities and discussion within each session is informed by the salient issues presented by participants. As such, materials (i.e., psychoeducation and skills training) are delivered using a consistent approach but the content of examples, discussion, and practice with the group is informed by the individuals within the group.
Intervention code [1] 327847 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337216 0
Body appreciation
Timepoint [1] 337216 0
Baseline, post-completion of treatment program and three-months after treatment completed
Primary outcome [2] 337217 0
Negative Body Image
Timepoint [2] 337217 0
Baseline, post-completion of treatment program and three-months after treatment completed
Primary outcome [3] 337218 0
Well-being
Timepoint [3] 337218 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [1] 431093 0
Appearance Satisfaction
Timepoint [1] 431093 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [2] 431094 0
Appearance Investment
Timepoint [2] 431094 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [3] 431095 0
Functional body image
Timepoint [3] 431095 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [4] 431096 0
Eating behaviour
Timepoint [4] 431096 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [5] 431097 0
Physical activity
Timepoint [5] 431097 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [6] 431098 0
Health-related quality of life
Timepoint [6] 431098 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [7] 431099 0
Self-compassion
Timepoint [7] 431099 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [8] 431100 0
Loneliness
Timepoint [8] 431100 0
Baseline, post-completion of treatment program and three-months after treatment completed
Secondary outcome [9] 431101 0
Program acceptability
Timepoint [9] 431101 0
Post-completion of treatment program and three-months after treatment completed

Eligibility
Key inclusion criteria
Must be diagnosed with a chronic illness by a medical professional. Specific conditions targeted include arthritis, asthma, back problems, cancer, cardiovascular disease, chronic obstructive pulmonary disease, diabetes, kidney disease, and osteoporosis. Individuals with other related chronic physical health conditions may also be eligible.
Living in the ACT or surrounds and attending ANU Psychology Clinic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: (i) Current suicidal thoughts, (ii) moderate to severe psychiatric illness (e.g., substance abuse, trauma, eating disorder, manic or psychotic episode, major depression), (iii) terminal illness, (iv) acute physical illness, (v) domestic violence or legal matters pending.
Must demonstrate social, linguistic and cognitive capacity to take part effectively in a psychological therapy group program. Exclusion criteria are assessed through initial screening procedures in the ANU Psychology Clinic, and if these arise during screening and assessment or during group participation, alternative referral options will be provided.

Study design
Purpose of the study
Educational / counselling / training
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 number of participants sought is up to 28. This is conservatively based on a medium effect size of f=.25, with an alpha of .05, power of .80, 1 group and three times of measurement using G Power. The effect size was selected based on other studies where CBT protocols have demonstrated large effects for body image outcomes, and medium or medium to large effects for other psychological outcome variables. Estimating a large effect recommends a sample size of 12.

Planned statistical analysis will examine descriptive statistics and distributions of variables, with intervention effects on primary and secondary outcomes over time assessed using One-Way Repeated Measures ANOVA. These analyses will include post-hoc tests enabling comparison of changes from baseline to post-treatment, baseline to follow-up, and post-treatment to follow-up. Due to the small sample size, non-parametric alternatives may be required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/03/2024
Actual
21/03/2024
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
28
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 315658 0
University
Name [1] 315658 0
Australian National University
Country [1] 315658 0
Australia
Primary sponsor type
Individual
Name
Dr Kristen Murray
Address
Country
Australia
Secondary sponsor category [1] 317764 0
None
Name [1] 317764 0
Address [1] 317764 0
Country [1] 317764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314542 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 314542 0
Ethics committee country [1] 314542 0
Australia
Date submitted for ethics approval [1] 314542 0
06/12/2023
Approval date [1] 314542 0
18/12/2023
Ethics approval number [1] 314542 0
Protocol 2021/326

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

Contacts
Principal investigator
Name 131954 0
Dr Kristen Murray
Address 131954 0
Building 39, School of Medicine and Psychology, Australian National University, Canberra ACT 2601
Country 131954 0
Australia
Phone 131954 0
+61 2 61252147
Fax 131954 0
Email 131954 0
[email protected]
Contact person for public queries
Name 131955 0
ANU Psychology Clinic
Address 131955 0
Building 39, School of Medicine and Psychology, Australian National University, Canberra ACT 2601
Country 131955 0
Australia
Phone 131955 0
+61 2 6125 8498
Fax 131955 0
Email 131955 0
[email protected]
Contact person for scientific queries
Name 131956 0
Kristen Murray
Address 131956 0
Building 39, School of Medicine and Psychology, Australian National University, Canberra ACT 2601
Country 131956 0
Australia
Phone 131956 0
+61 2 61252147
Fax 131956 0
Email 131956 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
De-identified and collated individual level data in a spreadsheet can be made available on request, but will only include overall scores rather than raw item data.


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.