Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001508167
Ethics application status
Approved
Date submitted
10/10/2019
Date registered
31/10/2019
Date last updated
2/03/2023
Date data sharing statement initially provided
31/10/2019
Date results information initially provided
2/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The BEKind Study: Psychological Wellbeing of Women with Endometriosis
Scientific title
The BEKind study: A longitudinal study exploring body image distress, self-compassion and psychological distress in women with endometriosis
Secondary ID [1] 299472 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BEKind Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 314695 0
Psychological Distress 314851 0
Condition category
Condition code
Mental Health 313042 313042 0 0
Other mental health disorders
Reproductive Health and Childbirth 313043 313043 0 0
Other reproductive health and childbirth disorders
Mental Health 313044 313044 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary aim of this study is to conduct an online longitudinal study over six months to determine the extent to which women with endometriosis experience body image disturbance, and delineate other psychological factors (such as self-compassion, anxiety and depression, quality of life and sexual distress) associated with changed body image. A secondary aim includes mapping and exploring the trajectories of psychological distress over time.

The following outcomes will be assessed:
1. Demographics – age, gender/sex, height, weight, BMI, country of birth, education level, relationship status, employment status, medical and obstetric history, endometriosis symptoms, date of diagnosis and stage.
2. Endometriosis Health Profile Questionnaire (EHP-30) – a 30-item scale which assesses the impact of endometriosis on physical, psychological and social aspects of life using a 5-point Likert scale
3. Self-Compassion Scale (SCS) – a 26-item scale which assesses the extent to which participants treat themselves kindly – six subscales with items rated on a Likert scale from 1 (almost never) to 5 (almost always)
4. Body Image Scale (BIS) – a 10-item scale which measures body image distress as well as cognitions and behaviours pertaining to body image and function.
5. Body Appreciation Scale-2 (BAS-2) – A 13-item scale which is a commonly utilised measure of positive body image
6. Depression and Anxiety Stress Scale (DASS-21) – A validated and commonly used measure for anxiety and depression. Participants are asked to rate the extent to which they agree with statements such as “I find it hard to wind down” on a 4-point Likert scale (0 = Never, 3 = Almost always).
7. Female Sexual Distress Scale-Revised (FSDS-R ) – a 12-item questionnaire which measures aspects of sexual distress using a 4-point Likert scale (0=Never, 4 =Always).
8. SF-36 Measure for Psychological Distress – a 36 item questionnaire measuring psychological distress

We will follow up participants at Baseline, 1, 3 and 6 months follow-up to analyse change over time.
Intervention code [1] 315726 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321590 0
Body image scale - a 10-item scale which measures body image distress as well as cognitions and behaviours pertaining to body image and function.
Timepoint [1] 321590 0
Baseline
1 month
3 month
6 months
Primary outcome [2] 321591 0
Body Appreciation scale - A 13-item scale which is a commonly utilised measure of positive body image
Timepoint [2] 321591 0
Baseline
1 month
3 month
6 months
Primary outcome [3] 321592 0
Depression and Anxiety as measured by the DASS 21 - 21 item measure whereby participants are asked to rate the extent to which they agree with statements such as “I find it hard to wind down” on a 4-point Likert scale (0 = Never, 3 = Almost always).
Timepoint [3] 321592 0
Baseline
1 month
3 month
6 months
Secondary outcome [1] 375500 0
Endometriosis Specific Health Profile (EHP-30) - designed by Oxford University - a 30-item scale which assesses the impact of endometriosis on physical, psychological and social aspects of life using a 5-point Likert scale
Timepoint [1] 375500 0
Baseline
1 month
3 month
6 months
Secondary outcome [2] 375501 0
Sexual Distress using the Female Sexual Distress Scale-Revised (FSDS-R) – a 12-item questionnaire which measures aspects of sexual distress using a 4-point Likert scale (0=Never, 4 =Always).
Timepoint [2] 375501 0
Baseline
1 month
3 month
6 months
Secondary outcome [3] 375502 0
Quality of Life - SF36 - measure of self-reported health
Timepoint [3] 375502 0
Baseline
1 month
3 month
6 month
Secondary outcome [4] 376175 0
Self-Compassion - a 26-item scale which assesses the extent to which participants treat themselves kindly – six subscales with items rated on a Likert scale from 1 (almost never) to 5 (almost always)
Timepoint [4] 376175 0
Baseline
1 month
3 months
6 months

Eligibility
Key inclusion criteria
Women (aged over 18 years) diagnosed by a health professional as having endometriosis, with access to the internet and competency of the English language
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are self-diagnosed or thought to have endometriosis without confirmation via surgery or ultrasound will be excluded from the analysis

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be collected via the secure online Qualtrics portal from Macquarie University, and used only by the research team. Statistical analysis will be conducted using SPSS and M+ and will involve logistic regression analysis and latent growth analysis to determine trajectories of psychological distress over the six month study duration.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
1/10/2019
Date of last data collection
Anticipated
21/08/2020
Actual
1/08/2020
Sample size
Target
300
Accrual to date
Final
584
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28230 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 303972 0
University
Name [1] 303972 0
Macquarie University
Country [1] 303972 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie Park
NSW 2109
Country
Australia
Secondary sponsor category [1] 304143 0
None
Name [1] 304143 0
Address [1] 304143 0
Country [1] 304143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304472 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 304472 0

Balaclava Road, North Ryde
NSW, 2109, Australia
Ethics committee country [1] 304472 0
Australia
Date submitted for ethics approval [1] 304472 0
01/07/2019
Approval date [1] 304472 0
15/08/2019
Ethics approval number [1] 304472 0
:52019565110023

Summary
Brief summary
This research aims to assess and measure various aspects of psychological wellbeing, self-compassion and body image disturbance in women with endometriosis over a six-month period. A secondary aim includes mapping and exploring the trajectories of psychological distress this duration of time. It is hypothesized that women with endometriosis will report high levels body image disturbance, anxiety and depression, and that this will correlate with reduced levels of self-compassion. In order to be able to mitigate these issues and help women cope with the day-to-day challenges of living with endometriosis, the crucial first step is quantifying the level of body image distress and its relationship to other psychological variables. Through a longitudinal design, we may be able to firstly identify the trajectory of psychological distress in this population, and furthermore delineate predictors of psychological distress over time. This research will form a foundation on which development of interventions that can address body image concerns and improve coping in women with endometriosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97066 0
Prof Kerry Sherman
Address 97066 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country 97066 0
Australia
Phone 97066 0
+612 9850 6874
Fax 97066 0
Email 97066 0
[email protected]
Contact person for public queries
Name 97067 0
Prof Kerry Sherman
Address 97067 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country 97067 0
Australia
Phone 97067 0
+612 9850 6874
Fax 97067 0
Email 97067 0
[email protected]
Contact person for scientific queries
Name 97068 0
Prof Kerry Sherman
Address 97068 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
Country 97068 0
Australia
Phone 97068 0
+612 9850 6874
Fax 97068 0
Email 97068 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
we do not have permission from the HREC to provide these data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5205Informed consent form  [email protected]
5207Ethical approval  [email protected] 378502-(Uploaded-24-10-2019-12-10-18)-Study-related document.pdf
5208Study protocol  [email protected] 378502-(Uploaded-10-10-2019-20-18-13)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Delineating sociodemographic, medical and quality ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDelineating sociodemographic, medical and quality of life factors associated with psychological distress in individuals with endometriosis.2021https://dx.doi.org/10.1093/humrep/deab138
N.B. These documents automatically identified may not have been verified by the study sponsor.