Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000217606
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
1/03/2023
Date last updated
1/03/2023
Date data sharing statement initially provided
1/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the efficacy and acceptability of an internet-delivered pain management program for endometriosis
Scientific title
Examining the efficacy and acceptability of an internet-delivered pain management program for endometriosis
Secondary ID [1] 308923 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 328927 0
Anxiety 328928 0
Chronic Pain 328929 0
Endometriosis 328930 0
Condition category
Condition code
Mental Health 325916 325916 0 0
Depression
Mental Health 325917 325917 0 0
Anxiety
Reproductive Health and Childbirth 326039 326039 0 0
Menstruation and menopause
Reproductive Health and Childbirth 326040 326040 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Endometriosis Pain Course is an internet-delivered self-management program. It is a psychological treatment based on cognitive behaviour therapy (CBT) principles adapted to address the impacts of endometriosis-associated symptoms and difficulties, such as chronic pain, on women's daily functioning and wellbeing.

The course consists of:
(a) Five lessons released via the eCentreClinic participant portal over an 8-week period. Each lesson is delivered individually and covers a different topic and introduces 1-2 core CBT skills designed to promote self-management, psychological wellbeing and quality of life. Lesson 1 (released in week 1) provides an introduction and overview of the course, psychoeducation on chronic pain, the pain system, and emotional wellbeing. Participants are encouraged to identify their symptoms (e.g., unhelpful thinking styles, physical symptoms, unhelpful coping strategies) as a home-based exercise. Lesson 2 (released in week 2) provides psychoeducation on unhelpful thinking, particularly as it relates to chronic pain and introduces cognitive challenging skills. Participants are encouraged to practise thought challenging in the following two weeks. Lesson 3 (released in week 4) covers behavioural activation and relaxation strategies to manage mood and anxiety symptoms, and participants are provided with the resources to undertake activity scheduling as a home-based task. Lesson 4 (released in week 5) introduces activity pacing to manage symptoms such as pain and fatigue, and graded exposure to manage anxiety and avoidance. Participants are encouraged to attempt activity pacing and/or graded exposure tasks as a home-based task. Lesson 5 (released in week 7) provides information and strategies relating to relapse prevention. Participants are given materials to develop their own relapse prevention plan and to help with goal-setting for the future. The duration of each lesson is approximately 20-30 minutes. Lessons are completed in weeks 1,2,4,5 and 7. Participants can view lessons via the eCentreClinic's online platform or download them as PDF files. Lessons are are accompanied by worksheets (called DIY guides) which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with the home-based exercises at a frequency and duration that is helpful for them, though a suggested time commitment of at least 30 minutes each week is encouraged.
(b) Additional Resources developed specifically for this intervention. These resources provide information about common problems people struggle with, and guidance on how to manage these, such as redirecting attention from pain, managing sleep, working with health professionals etc.
(c) Automatic emails that help guide people through the course. Examples of these e-mails include: reminders when new lessons are available, congratulatory messages once a lesson has been completed, brief messages that reinforce the core concepts of the lessons and e-mails inviting contact and encouraging engagement if a participant has not logged in for a while.

Participants will have the option of accessing support from a Clinical Psychologist who will be available during the 8 weeks to discuss concepts, answer questions and promote and encourage skills practise. Participants will have the opportunity to schedule regular phone calls with the Clinical Psychologist during the first few weeks of the Course. Participants can also contact the Clinical Psychologist via email and through the secure private messaging system accessed via their participant log in on the eCentreClinic website. The Clinical Psychologist is nationally registered and employed by Macquarie University. They will be provided with training and supervision from a senior psychologist to ensure competence and safety in their practice. Adherence with the intervention is monitored via the study's secure web platform, which records information such as the number of participant log-ins, lesson completions, time spent completing each lesson and number of downloads of additional resources.
Intervention code [1] 325367 0
Behaviour
Intervention code [2] 325368 0
Treatment: Other
Comparator / control treatment
The control condition is a Treatment-As-Usual Waitlist Control group who begin the treatment immediately after the treatment groups complete the Course. Treatment-As-Usual comprises any treatments that participants obtain via the care of their regular health professionals and general engagement with the health system across the treatment period.
Control group
Active

Outcomes
Primary outcome [1] 333757 0
Patient Health Questionnaire - 9 (PHQ-9) which is a self-report measure of depressive symptomatology.
Timepoint [1] 333757 0
Application prior to enrolment, pre-treatment, mid-treatment (4 weeks post-treatment commencement), post-treatment (9 weeks post-treatment commencement, primary endpoint), 3-months post-treatment commencement.
Primary outcome [2] 333758 0
Generalised Anxiety Disorder - 7 (GAD-7) which is a self-report measure of anxiety symptomatology.
Timepoint [2] 333758 0
Application prior to enrolment, pre-treatment, mid-treatment (4 weeks post-treatment commencement), post-treatment (9 weeks post-treatment commencement, primary endpoint), 3-months post-treatment commencement.
Primary outcome [3] 333759 0
Pain Disability Index 7-Item (PDI) which is a self-report measure assessing the impact of chronic pain on different life domains.
Timepoint [3] 333759 0
Application prior to enrolment, pre-treatment, mid-treatment (4 weeks post-treatment commencement), post-treatment (9 weeks post-treatment commencement, primary endpoint), 3-months post-treatment commencement.
Secondary outcome [1] 418198 0
Wisconsin Brief Pain Questionnaire 4-Item (WBPQ-4) which is a widely used questionnaire measuring the nature of participants’ pain including location, severity, and responsiveness to pain medications.
Timepoint [1] 418198 0
Application prior to enrolment, pre-treatment, mid-treatment (4 weeks post-treatment commencement), post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [2] 418199 0
Pain Catastrophising Scale 4-Item (PCS-4) which is an abbreviated version of the original 13-item measure that assesses a participants’ thoughts and feelings when in pain.
Timepoint [2] 418199 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [3] 418200 0
Pain Self Efficacy Questionnaire 2-Item (PSEQ-2) which is an abbreviated version of the original 10-item measure which rates participants’ confidence in performing various daily activities despite pain.
Timepoint [3] 418200 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [4] 418201 0
Fear of Pain Questionnaire 9-Item (FOPQ-9) which is an abbreviated version of the original 30-item questionnaire that measures participants’ expected fearfulness towards a range painful experiences.
Timepoint [4] 418201 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [5] 418202 0
Pain Acceptance 8-Item (CPAQ-8) which is an 8-item measure designed to get a sense of peoples’ adjustment to living with pain.
Timepoint [5] 418202 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [6] 418203 0
Tampa Scale of Kinesiophobia 4-Item (TSK) which is an abbreviated version of the original 17-item scale assessing fear of movement and re-injury.
Timepoint [6] 418203 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [7] 418204 0
Endometriosis Health Profile 5-Item (EHP-5) which is a 5-item short form measuring the health-related quality of life in women with endometriosis.
Timepoint [7] 418204 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [8] 418205 0
Endometriosis Health Profile Modular Questionnaire 23-Item (EHP-23) which is a 23-item adjunct to the Endometriosis Health Profile Questionnaire measuring impact of endometriosis on work, relationships, and interactions with the healthcare system.
Timepoint [8] 418205 0
Pre-treatment, post-treatment (9 weeks post-treatment commencement), 3-months post-treatment commencement.
Secondary outcome [9] 418206 0
The Treatment Satisfaction Questionnaire (TSQ) which is a purpose-built measure to assess the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment.
Timepoint [9] 418206 0
Post-treatment (9 weeks post-treatment commencement).

Eligibility
Key inclusion criteria
(a) Diagnosis of endometriosis by a medical professional and experiencing endometriosis-associated chronic pain
(b) Chronic pain has been assessed and is being managed by a healthcare physician
(c) Endometriosis-related chronic pain/symptoms are affecting (self-reported) psychological wellbeing, impacting functioning, or causing the individual problems at work, socially, or in another important way
(d) Aged 18 or over
(e) Access to the internet and an internet-connected device.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Current severe medical or psychiatric disorder that requires immediate treatment (e.g., current mania or psychosis, actively suicidal or unable to maintain safety, medical condition requiring immediate surgery or other invasive treatment)
(b) Not living in Australia
(c) Unable to read and understand English.

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)
Participants apply online via the clinic's website (www.ecentreclinic.org). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
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
This study is powered to detect small-to-moderate effect changes (i.e., Cohen’s d > 0.4+) in anxiety and depressive symptoms, pain and disability at each time point. Generalised Estimating Equation (GEE) models will be used to examine the main effects for group and time, and the group by time interaction, for each outcome variable. Subgroup analyses are planned, which will examine these outcomes on the basis of initial symptom severity on the primary outcomes (anxiety, depression, disability) and endometriosis disease stage. Clinical levels of baseline symptoms will be based on the published literature e.g., depression (PHQ-9>9), anxiety (GAD-7 >9). Proportions of participants achieving clinically significant change will be calculated and reported for the primary (anxiety, depression, disability) and secondary outcomes (pain intensity), and operationalised as an improvement (from baseline) of greater than or equal to 30% and greater than or equal to 50%. Proportions of participants deteriorating will also be calculated and reported, using participant self-report as well as being operationalised as a deterioration in symptoms (from baseline) of greater than or equal to 30% and resultant symptoms in a clinical range.

All analyses will be carried out using conservative intention-to-treat principles, with Multiple Imputation employed to generate replacement values for missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
13/03/2025
Actual
Date of last data collection
Anticipated
13/06/2025
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313132 0
University
Name [1] 313132 0
Macquarie University
Country [1] 313132 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Balaclava Rd
Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 314834 0
None
Name [1] 314834 0
Address [1] 314834 0
Country [1] 314834 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312377 0
Macquarie University Medical Sciences Human Research Ethics Committee
Ethics committee address [1] 312377 0
Balaclava Road
Macquarie Park NSW 2109
Ethics committee country [1] 312377 0
Australia
Date submitted for ethics approval [1] 312377 0
31/10/2022
Approval date [1] 312377 0
09/02/2023
Ethics approval number [1] 312377 0

Summary
Brief summary
The Endometriosis Pain Course is an internet-delivered psychological treatment that addresses the impacts of endometriosis-associated symptoms and difficulties, such as chronic pain, on women's daily functioning and wellbeing. The course is based on cognitive behaviour therapy principles and consists of 5 lessons released over an 8-week period. Each lesson covers a different topic and introduces 1-2 core CBT skills designed to promote self-management, psychological wellbeing and quality of life. In addition to the core lessons, the program includes extra resources such as redirecting attention from pain and do-it-yourself guides to promote skills practise. Alongside the internet-delivered materials, participants have the option of accessing telephone support from a Clinical Psychologist who is available during the 8 weeks to discuss concepts, answer questions and promote and encourage skills practise.

This intervention will be a modified version of the Pain Course, which was developed and validated through 4 randomised controlled trials by the eCentreClinic at Macquarie University and is now widely available through the MindSpot Clinic. The aim of this study is to investigate the efficacy of a psychologically-based pain management program when specifically adapted for women with endometriosis. We hypothesise that, compared to a delayed treatment waitlist group, participants in the Endometriosis Pain Course will report greater symptom improvements (in terms of mood, anxiety and level of pain-related disability). By recruiting a large group of participants, we are also aiming to understand what particular groups of people (or what participant characteristics) may benefit most from the Endometriosis Pain Course.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124442 0
Prof Blake Dear
Address 124442 0
Department of Psychology
Macquarie University
Balaclava Road
Macquarie Park NSW 2109
Country 124442 0
Australia
Phone 124442 0
+6129850 9979
Fax 124442 0
Email 124442 0
blake.dear@mq.edu.au
Contact person for public queries
Name 124443 0
Ms Shanika Chandra
Address 124443 0
Department of Psychology
Macquarie University
Balaclava Road
Macquarie Park NSW 2109
Country 124443 0
Australia
Phone 124443 0
+6129850 9643
Fax 124443 0
Email 124443 0
shanika.chandra@hdr.mq.edu.au
Contact person for scientific queries
Name 124444 0
Ms Shanika Chandra
Address 124444 0
Department of Psychology
Macquarie University
Balaclava Road
Macquarie Park NSW 2109
Country 124444 0
Australia
Phone 124444 0
+6129850 9643
Fax 124444 0
Email 124444 0
shanika.chandra@hdr.mq.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?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
When will data be available (start and end dates)?
Data will be made after any original reports have been published. There will be no end date to the availability.
Available to whom?
Researchers working with the approval and under the governance of an Australian Human Research Ethics Committee
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the chief investigator (blake.dear@mq.edu.au)


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.