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Trial registered on ANZCTR


Registration number
ACTRN12622000283774
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
15/02/2022
Date last updated
7/04/2024
Date data sharing statement initially provided
15/02/2022
Date results information initially provided
7/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Compassion Focused Therapy on psychological well­being in women with Lipoedema
Scientific title
Compassion, psychological well­being and microbiome: a randomised controlled study of women with lipoedema engaged in a group-based compassion focused intervention
Secondary ID [1] 305907 0
Nil/none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 324476 0
Lipoedema 324477 0
Condition category
Condition code
Mental Health 321962 321962 0 0
Depression
Cardiovascular 322517 322517 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10-week online intervention in groups of up to 15 participants, will be conducted with weekly sessions of 2.5 hours for 4 weeks with a 2 week practice break, followed by a further 4 weeks of weekly sessions. Sessions are delivered by a Clinical Psychologist. Participants are followed up at 8 weeks post completion of the intervention. Participants are invited to complete outcome measures at baseline, post intervention and at 8 weeks and 24 weeks follow-up. Weekly self-report measures of overall engagement and practice, as well as session attendance will be used to monitor engagement in the intervention.

The session content includes education and skills training in which participants are taught to regulate threat-based emotions compassionately through practices including: soothing rhythm breathing; attention and mindfulness practices; imagery practices aimed at developing a ‘compassionate self’ that is wise, strong, and committed; and practice to develop caring intent towards others and the self (self compassion) to deal with self-criticism and life stressors.
Intervention code [1] 322303 0
Behaviour
Intervention code [2] 322750 0
Treatment: Other
Comparator / control treatment
Control condition involves a baseline, 10 week and 8 week follow-up (18 weeks) and 24 week follow-up (34 weeks) completion of measures in line with the active condition, however there is no active intervention of group involvement. Those within the waitlist control condition will be provided opportunity to engage in the active intervention following the completion of the study, which is after completion of all follow-up measures at 6 months post intervention.
Control group
Active

Outcomes
Primary outcome [1] 329714 0
Depression assessed using the Patient Health Questionnaire( PHQ-9)
Timepoint [1] 329714 0
Baseline, post-intervention (10 weeks post-intervention commencement, primary endpoint), and follow-up (8 weeks post-intervention, and 24 weeks post-intervention completion)..
Primary outcome [2] 329715 0
Compassion assessed using the Compassion Motivation and Action Scales (CMAS)
Timepoint [2] 329715 0
Baseline, post-intervention (10 weeks post-intervention commencement, primary endpoint), and follow-up (8 weeks post-intervention, and 24 weeks post intervention completion).
Secondary outcome [1] 403572 0
Social context - self relating assessed with Fears of Compassion Scale (FCS)
Timepoint [1] 403572 0
Baseline, post-intervention (10 weeks post-intervention commencement), and follow-up (8 weeks post-intervention, and 24 weeks post intervention completion).
Secondary outcome [2] 403573 0
A subset of participants, randomly selected from enrolled participants, microbiome composition. This will be collected via stool samples in an easy to use swab method and will be profiled with metagenomic sequencing.
Timepoint [2] 403573 0
Baseline, post-intervention (10 weeks post-intervention commencement)
Secondary outcome [3] 405720 0
Well-being assessed with Mental Health Continuum-short Form ( MHC-SF)
Timepoint [3] 405720 0
Baseline, post-intervention (10 weeks post-intervention commencement), and follow-up (8 weeks post-intervention, and 24 weeks post intervention completion).

Eligibility
Key inclusion criteria
- An Australian resident
- Over 18 years-old
- Female (at birth)
- Diagnosed with lipoedema
- Able to gain access to zoom/telehealth technology in a private area (to keep confidentiality of other participants)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- currently undertaking another psychological intervention
- have, including a history of, conditions known to affect cognitive performance (such as traumatic brain injury, dementia, recent experience of seizures or neurological disruption)
- have changed medication related to your psychological health in the past month

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)
Allocation is not concealed
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a meta­-analysis of 21 randomised controlled trials of compassion-­based studies (Kirby et al., 2017) that showed moderate effects on depression and compassion, sample sizes ranged between n=28 to n=228 participants with 85% of studies consisting of <n=81 and the median sample size being n=50 adults. For this study and based on anecdotal feedback and interest in the trial, we anticipate engaging 30 per group ( N= 60) through two, staggered recruitment waves. For those in the control condition, opportunity to engage with the therapeutic support will be provided at the completion of the study. Further, approximately it is anticipated that attrition for this study will be minimal, as the need and demand for services and psychological support is required. Nonetheless, to obtain clinically meaningful outcomes, a sample size of 60 will be recruited to account for any attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/02/2022
Actual
23/02/2022
Date of last participant enrolment
Anticipated
4/05/2023
Actual
31/07/2022
Date of last data collection
Anticipated
20/12/2023
Actual
30/10/2023
Sample size
Target
90
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310257 0
University
Name [1] 310257 0
Central Queensland University
Country [1] 310257 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
A/Prof Talitha Best
School of Health Medical and Applied Science
Central Queensland University
160 Ann Street, Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 311356 0
University
Name [1] 311356 0
University of Queensland
Address [1] 311356 0
Dr James Kirby
School of Psychology
University of Queensland
St Lucia, QLD 4072
Country [1] 311356 0
Australia
Other collaborator category [1] 282080 0
Charities/Societies/Foundations
Name [1] 282080 0
Compassionate Mind Foundation
Address [1] 282080 0
The Compassionate Mind Foundation
Office 29,
Riverside Chambers
1 Full Street
Derby
DE1 3AF
Country [1] 282080 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309929 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 309929 0
Research Division (Building 32 Level 2)
CQUniversity Australia
Bruce Highway
North Rockhampton QLD 4701
Australia
Ethics committee country [1] 309929 0
Australia
Date submitted for ethics approval [1] 309929 0
23/11/2021
Approval date [1] 309929 0
18/01/2022
Ethics approval number [1] 309929 0
HREC0000023305

Summary
Brief summary
Chronic disease, such as lipoedema, has a negative impact on mental health and is associated with increased psychological distress, depression and anxiety. This project uses a randomised-controlled design (with an active intervention and waitlist control condition) to investigate the impact of an online, group based psychological intervention using compassion focused therapy (CFT) to improve the mental well­being of women with Lipoedema.

Using a 10-week intervention design and follow-up at 8-weeks and 24-weeks post intervention completion, participants will engage in an online delivered group intervention, Participants will complete measures at baseline, post intervention and follow-­up. In addition, a subset of participants will contribute to an understanding of the biological mechanisms underpinning psychological change through gut-­brain related changes in microbiome. This project aims to improve the mental health of participants and provide critical, integrated bio­psychological and therapeutic focused research to promote well­being in lipoedema.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115874 0
A/Prof Talitha Best
Address 115874 0
School of Health, Medical and Applied Science
160 Ann Street, Brisbane QLD 4000
Country 115874 0
Australia
Phone 115874 0
+61732951131
Fax 115874 0
Email 115874 0
t.best@cqu.edu.au
Contact person for public queries
Name 115875 0
Ms Chantelle Clarke
Address 115875 0
School of Health, Medical and Applied Science
160 Ann Street, Brisbane QLD 4000
Country 115875 0
Australia
Phone 115875 0
+61732951131
Fax 115875 0
Email 115875 0
c.clarke2@cqu.edu.au
Contact person for scientific queries
Name 115876 0
A/Prof Talitha Best
Address 115876 0
School of Health, Medical and Applied Science
160 Ann Street, Brisbane QLD 4000
Country 115876 0
Australia
Phone 115876 0
+61732951131
Fax 115876 0
Email 115876 0
t.best@cqu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified primary outcome data
When will data be available (start and end dates)?
The data will be available following publication and for up to 5 years following publication
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose, for meta-analyses,
How or where can data be obtained?
Access subject to approvals by Principal Investigator by emailing t.best@cqu.edu.au and/or public data repository upon publication.


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.