ANZCTR - Registration

Registration number

ACTRN12618001247268

Ethics application status

Approved

Date submitted

18/07/2018

Date registered

24/07/2018

Date last updated

13/12/2019

Date data sharing statement initially provided

9/01/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Compassion Focused Therapy as a Treatment for Body Weight Shame Associated with Obesity.

Scientific title

Compassion Focused Therapy as a Treatment for Body Weight Shame Associated with Obesity.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1214-9466

Trial acronym

Linked study record

This study is linked to ACTRN12618001233213 which is the pilot study for the current study.

Health condition

Health condition(s) or problem(s) studied:

Obesity

Depression

Anxiety

Stress

Compassion

General psychological well-being

Condition category

Condition code

Public Health

Health service research

Mental Health

Depression

Mental Health

Anxiety

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Compassion focused therapy will be delivered to participants across 12 x 2 hour sessions. 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. Availability, participants must agree to attend all sessions. If they are unavailable to commit to the required therapy times they will not be allowed to participate in the study. All participants must be over the age of 18.

Assessment items (pre and post) will be administered online via Qualtrics for self-report surveys and in person for physiological assesment. Participants will be asked if they wish to complete follow-up assessment items administered online via Qualtrics 6-months after the completion of the intervention.

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]

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]

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]

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]

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.

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

Timepoint [1]

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]

Compassion comprises of two outcome measurements. The first outcome is self-compassion, measured through the online, self-report self-compassion scale (SCS). All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.

Timepoint [2]

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]

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]

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]

The fourth secondary outcome measure is: Physical changes. Measured through Heart Rate Variability assessment preformed by EEG studies.

Timepoint [4]

Assessment time points will occur at baseline and immediately following session 12.

Secondary outcome [5]

The second element of mental health, mental well being outcome, will be measured through the Mental Health Continuum Short Form Scale (MHC-SF). All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.

Timepoint [5]

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]

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 [6]

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]

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 [7]

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]

Compassion comprises of two outcome measurements. The second outcome is fears of compassion. This is measured through the Fears of Compassion Scale (FOCS).
All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.

Timepoint [8]

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]

Process variables consist of 8 outcome measures. The first of which is social identification as Obese. This is measured, 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]

Assessment time points will occur immediately following each therapy sessions. 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]

Process variables consist of 8 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 [10]

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 [11]

Process variables consist of 8 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 [11]

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 [12]

Process variables consist of 8 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 [12]

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 [13]

Process variables consist of 8 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 [13]

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]

Process variables consist of 8 outcome measures. The sixth of which is the completion of the work practice diary. This is measured through self-report on the a checklist of completing practice tasks. The practice diary is an element of the CFT manual.

Timepoint [14]

Assessment time points will occur fortnightly following every second therapy session. 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 [15]

Process variables consist of 8 outcome measures. The seventh of which is group cohesion. This is measured, 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 [15]

Assessment time points will occur immediately following each therapy sessions. No follow-up assessment will occur.

Secondary outcome [16]

Process variables consist of 8 outcome measures. The final of which is social identification as a self-compassionate person. This is measured, 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 [16]

Assessment time points will occur immediately following each therapy sessions. 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 [17]

The third element of mental health, mental well being outcome, will be measured through the Interpersonal Emotion Regulation Questionnaire (IERQ). All scales have been deemed valid and reliable across previous research in clinical and non clinical populations.

Timepoint [17]

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.

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

Sex

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

Statistical methods / analysis

Following a power analysis it has been identified that 70-80 participants will be needed to have sufficient power for statistical tests in the main study. Based on previous research, participants will be randomly assigned to therapy groups of 8-10 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

Recruiting

Date of first participant enrolment

Anticipated

9/01/2019

Actual

5/02/2019

Date of last participant enrolment

Anticipated

8/06/2020

Actual

Date of last data collection

Anticipated

1/12/2020

Actual

Sample size

Target

90

Accrual to date

35

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr James Kirby

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Alicia Carter

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Institutional Human Research Ethics Committee A [EC00456]

Ethics committee address [1]

The University of Queensland, 
St Lucia, 
Brisbane, 
Queensland, 
4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/02/2018

Approval date [1]

23/05/2018

Ethics approval number [1]

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

Public notes

Attachments [1]

/AnzctrAttachments/375626-2018000467 - Approval Form.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr James Kirby

Address

The University of Queensland
St Lucia,
Brisbane,
Queensland,
4072

Country

Australia

Phone

+61 07 33651111

Email

[email protected]

Contact person for public queries

Name

Alicia Carter

Address

The University of Queensland
St Lucia,
Brisbane,
Queensland,
4072

Country

Australia

Phone

+61 07 33651111

Email

[email protected]

Contact person for scientific queries

Name

Alicia Carter

Address

The University of Queensland
St Lucia,
Brisbane,
Queensland,
4072

Country

Australia

Phone

+61 07 33651111

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically