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Trial registered on ANZCTR


Registration number
ACTRN12618001233213
Ethics application status
Approved
Date submitted
11/07/2018
Date registered
23/07/2018
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Date results information initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot: Compassion Focused Therapy as a Treatment for Body Weight Shame Associated with Obesity.
Scientific title
Pilot: Compassion Focused Therapy as a Treatment for Body Weight Shame Associated with Obesity.
Secondary ID [1] 295051 0
None
Universal Trial Number (UTN)
U1111-1214-9466
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 308090 0
Depression 308091 0
Anxiety 308092 0
Stress 308093 0
Compassion 308160 0
General psychological well-being 308161 0
Condition category
Condition code
Public Health 307135 307135 0 0
Health service research
Mental Health 307136 307136 0 0
Depression
Diet and Nutrition 307137 307137 0 0
Obesity
Mental Health 307804 307804 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compassion focused therapy will be delivered to participants across 12 x 2 hour session. The intervention will be co-facilitated by an experienced registered clinical psychologist and a provisional health psychologist at the University of Queensland, Brisbane.

The procedures, activities and processes used will follow the 12 week therapy protocol of Compassion Focused Therapy titled 'Compassion Focused Therapy: Group Manual' by Gilbert, Kirby and Petrocchi (in press). It will be delivered face to face in a group therapy format. Covering understanding the mind, mindfulness, compassion and compassion cultivation.
The Compassion Focused Group Therapy program is comprised of approximately one 2-hour session per week. The program will focus on practices including: (1) a soothing rhythm breathing practice; (2) a practice focused on creating friendly facial expressions and voice tones as part of compassion; (3) a practice aimed to develop mindfulness and increase attention to one’s current mental state; (4) a practice aimed to develop the sense of a compassionate self that is based upon feelings of wisdom, strength and commitment to be supportive and helpful to self and others; (5) an imagery practice aimed to develop a compassionate image of another mind that has caring intent towards the self; and (6) a practice aimed to develop a compassionate self that has caring intent towards the self and how to use compassion focusing to work with self-criticism and life difficulties.
Below is weekly agenda outlining the content covered during each session:
1. An introduction to compassion
2. Fears and blockers, the balancing effect of compassion and a compassion focused reality check
3. Mindfulness and soothing, rhythm, breathing
4. Introduction to compassion from others
5. Introduction to the compassionate self
6. Self-criticism
7. Shame and guilt
8. Compassion for self
9. Understanding of our multiple selves
10. Compassion for others
11. Compassion assertiveness
12. Wrap-up content and reflection

Inclusion criteria (obesity - as determined by body weight index and body weight shame) will be assessed over the phone as self reported measures when participant interest is expressed. Assessment items (pre and post) will be administered online via Qualtrics.

Participants attendance will be reordered via a roll check list at the start of each session by the lead researcher.

Groups will consist of approximately 6 participants as per previous research recommendations (Dutton et al 2014).


Intervention code [1] 301384 0
Treatment: Other
Comparator / control treatment
Treatment as usual - wait list control.
At the end of the study. All participants will be offered treatment.
Control group
Active

Outcomes
Primary outcome [1] 306091 0
Body weight shame. Measured through the following online, self report survey:
• Body weight shame (BISS)

Body image shame scale (BISS) is a valid and reliable measure for the assessment of body image shame (Duarte, Pinto-Gouveia, Ferreira & Batista., 2014).
Timepoint [1] 306091 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.

Primary outcome time point will be baseline and immediately following session 12.
Secondary outcome [1] 347552 0
Mental health will be measured through four scales: The first outcome will be depression, stress and anxiety measured by: Depression, Stress and Anxiety Scale (DASS)

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [1] 347552 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [2] 347555 0
Compassion comprises of two outcome measurements. The first outcome is compassion, engagement and action. Measured through the online, self-report Compassion, Engagement and Action Scale (CEAS).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [2] 347555 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [3] 347556 0
The third secondary outcome measure is: Relationship with food. Measured through the following online, self report survey:
• Eating Attitudes Test (EAT)

The EAT has been deemed a valid and reliable across previous research in clinical and non clinical populations.
Timepoint [3] 347556 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [4] 349771 0
The second element of mental health, mental well being outcome, will be measured through the Mental Well-being (WEMWB) scale.

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [4] 349771 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [5] 349772 0
The third element of mental health, will be measured by assessed levels of internal shame, external shame, proneness to shame, guilt, pride and detachment outcomes. This will be measured through the Other As Shamer (OAS) scale.

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.

Timepoint [5] 349772 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [6] 349776 0
The final measurement of Mental Health will be acquired through the online self-report measure of criticism and reassurance outcomes. This is achieved through the Forms of Self-Criticising/Attacking and Self-Reassurance Scale (SCASRS).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [6] 349776 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [7] 349777 0
Compassion comprises of two outcome measurements. The second outcome is fears of compassion. This is measured through the Fears of Compassion Scale (FOCS).
Timepoint [7] 349777 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [8] 349778 0
Process variables consist of 7 outcome measures. The first of which is social identification as Obese. This is measured online, through self-report on the single item social identity measure (SISI).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [8] 349778 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [9] 349779 0
Process variables consist of 7 outcome measures. The second of which is social identification as a member of the therapy group. This is measured online, through self-report on the single item social identity measure (SISI).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [9] 349779 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [10] 349780 0
Process variables consist of 7 outcome measures. The third of which is the perception of social rank and social standing. This is measured online, through self-report on Social Comparison Rating Scale (SCRS).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [10] 349780 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [11] 349781 0
Process variables consist of 7 outcome measures. The fourth of which is behavioural submission and depression. This is measured online, through self-report on Submissive Behaviour Scale (SBS).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [11] 349781 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [12] 349782 0
Process variables consist of 7 outcome measures. The fifth of which is a sense of failed struggle and losing rank. This is measured online, through self-report on the Defeat Scale (DScale).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [12] 349782 0
Assessment time points will occur at baseline and immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [13] 349783 0
Process variables consist of 7 outcome measures. The sixth of which is the completion of the work practice diary. This is measured online, through self-report on the a checklist of completing practice tasks.

The practice diary is an element of the CFT manual.
Timepoint [13] 349783 0
Assessment time points will occur at immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.
Secondary outcome [14] 349784 0
Process variables consist of 7 outcome measures. The final of which is group cohesion. This is measured online, through self-report on the Group Cohesion Questionnaire (GCQ).

All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.
Timepoint [14] 349784 0
Assessment time points will occur at immediately following session 12. Additional assessment time points will be offered for interested participants at 6 months after the complement of their intervention and at 12 months after the complement of their intervention. Follow-up assessment time points are not a participant requirement of the study.

Eligibility
Key inclusion criteria
1) Age (over the age of 18+)
2) Body weight shame (score greater than 2 on the body weight shame scale)
3) Obesity (as measured through body mass index)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Currently under going mental health treatment (pharmaceutical or psychotherapy).
2) Unable to commit to session times.
3) If inclusion criteria is not met.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin tossing
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We will be conducting a pilot study (N = 6-10 participants). Following a power analysis and previous pilot group therapy studies, it has been identified that 6 - 10 participants will be needed to have sufficient power for statistical testing. Based on previous research, participants will be randomly assigned to therapy groups of approximately 6 participants.

SPSS statistical software will be used to analyse the data. A repeated measures ANOVA will be used to analyse the data obtained.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299633 0
University
Name [1] 299633 0
University of Queensland
Address [1] 299633 0
The University of Queensland,
St Lucia,
Brisbane,
Queensland,
4072
Country [1] 299633 0
Australia
Primary sponsor type
Individual
Name
Dr James Kirby
Address
The University of Queensland,
St Lucia,
Brisbane,
Queensland,
4072
Country
Australia
Secondary sponsor category [1] 298957 0
Individual
Name [1] 298957 0
Alicia Carter
Address [1] 298957 0
The University of Queensland,
St Lucia,
Brisbane,
Queensland,
4072
Country [1] 298957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300531 0
The University of Queensland Institutional Human Research Ethics Committee A [EC00456]
Ethics committee address [1] 300531 0
The University of Queensland,
St Lucia,
Brisbane,
Queensland,
4072
Ethics committee country [1] 300531 0
Australia
Date submitted for ethics approval [1] 300531 0
16/02/2018
Approval date [1] 300531 0
23/05/2018
Ethics approval number [1] 300531 0
2018000467

Summary
Brief summary
The purpose of the study is to investigate the effectiveness of compassion focused therapy as a treatment for body weight shame associated with obesity. Over the course of a 12 week compassion focused therapy program proposed by the Compassion Focused Therapy: Group Therapy manual by Gilbert, Kirby and Petrocchi (in press); participants will be assessed at pre, post and follow up times across primary and secondary outcome measures. Outcome measures are associated with mental health, compassion, relationship with food, physical health, and process variables.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2877 2877 0 0

Contacts
Principal investigator
Name 83962 0
Dr James Kirby
Address 83962 0
The University of Queensland
St Lucia,
Brisbane,
Queensland,
4072
Country 83962 0
Australia
Phone 83962 0
+61 07 33651111
Fax 83962 0
Email 83962 0
j.kirby@psy.uq.edu.au
Contact person for public queries
Name 83963 0
Miss Alicia Carter
Address 83963 0
The University of Queensland
St Lucia,
Brisbane,
Queensland,
4072
Country 83963 0
Austria
Phone 83963 0
+61 07 33651111
Fax 83963 0
Email 83963 0
alicia.carter@uqconnect.edu.au
Contact person for scientific queries
Name 83964 0
Miss Alicia Carter
Address 83964 0
The University of Queensland
St Lucia,
Brisbane,
Queensland,
4072
Country 83964 0
Austria
Phone 83964 0
+61 07 33651111
Fax 83964 0
Email 83964 0
alicia.carter@uqconnect.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?
all of the individual participant data collected during the trial, after de-identification will be shared
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
anyone who wishes to access it.
Available for what types of analyses?
any purpose
By what mechanism will data be made available?
unrestricted access via web address. DOI access code will be created via the University of Queensland once collection has been completed.
What supporting documents are/will be available?
Ethical approval
Attachments/websites
Type [1] 978 0
Ethical approval
URL/details/comments [1] 978 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary