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Trial registered on ANZCTR


Registration number
ACTRN12624000362594
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptance and Commitment Therapy for Endometriosis (ACTforEndo)
Scientific title
Pilot testing the acceptability, feasibility and preliminary efficacy of 'ACTforEndo': a modular, online telehealth-delivered acceptance and commitment therapy program for people living with endometriosis
Secondary ID [1] 311102 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACTforEndo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 332257 0
Condition category
Condition code
Reproductive Health and Childbirth 328974 328974 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACTforEndo is a modular, online, telehealth delivered acceptance and commitment therapy (ACT) based program for people living with endometriosis. This online intervention is an adaptation of a previously developed and tested ACT program and has been specifically tailored for this population. The aim of this study is to evaluate the acceptability, feasibility and preliminary efficacy of ACTforEndo (versus waitlist control)

In summary, ACTforEndo is a flexible, self-guided intervention, where the dose and content of the intervention is individualised to each participant based on their personal needs and attributes and overall program engagement. A suggested order for completion of the modules will be provided to participants, however this will not be compulsory and participants will have access to all module content. The intervention includes 6 self-directed, adapted modules comprising of a mix of video, audio, and written resources. The modules have been developed to address different ACT themes and processes to help better support and manage endometriosis-related experiences, thoughts, feelings and bodily sensations. The program includes experiential practices (such as meditation), practical worksheets and activities and reflective journalling, to help enhance quality of life, mental health, perceived pain and/or fatigue. The intervention is intended to be an adjunct support and will be provided during, and in addition to, the participant's usual care, as provided and administered by their healthcare practitioner(s) in line with agreed treatment practice.

Participants will be asked to complete one module a week, for 6-weeks. Each recorded module will be up to 30-minutes in duration, with an estimated total weekly commitment not exceeding 1.5 hours. Participants will be provided a reminder about completing the following weeks module as required. Participant usage data will be collected to monotor adherence including online access date, log in / log out start and end time (total access/usage time), global session and sub-session use for individual users and group average. The specific goals of the intervention will vary for each person, depending on their individual symptoms, severity of disease, expectations, motivations, life experience, and what they want to achieve from the intervention.
Intervention code [1] 327549 0
Behaviour
Intervention code [2] 327550 0
Lifestyle
Intervention code [3] 328120 0
Treatment: Other
Comparator / control treatment
Waitlist control: Participants randomised to waitlist will continue their usual medical care and will be offered ACTforEndo at the end of the study (3-months post randomisation)
Control group
Active

Outcomes
Primary outcome [1] 337712 0
Acceptability
Timepoint [1] 337712 0
Weekly for 6 weeks during the trial
Primary outcome [2] 337713 0
Acceptability
Timepoint [2] 337713 0
Post intervention (at 6-weeks)
Primary outcome [3] 337714 0
Feasibility
Timepoint [3] 337714 0
Feasibility will be measured at completion of the intervention (post-intervention at 6 weeks).
Secondary outcome [1] 430602 0
Pain (functioning)
Timepoint [1] 430602 0
Baseline, post-treatment at 6 weeks, 3-month follow-up
Secondary outcome [2] 430605 0
Fatigue
Timepoint [2] 430605 0
Baseline, post-treatment at 6 weeks, 3-month follow-up
Secondary outcome [3] 432366 0
Pain (catastrophising)
Timepoint [3] 432366 0
Baseline, post-treatment at 6 weeks, 3-month follow-up
Secondary outcome [4] 432925 0
Quality of life
Timepoint [4] 432925 0
Baseline, post-treatment at 6 weeks, 3-month follow-up
Secondary outcome [5] 432926 0
Psychological Symptoms
Timepoint [5] 432926 0
Baseline, post-treatment at 6 weeks, 3-month follow-up
Secondary outcome [6] 433101 0
Health-related Quality of Life
Timepoint [6] 433101 0
Baseline, post intervention (6weeks) and follow up (3 months)
Secondary outcome [7] 433102 0
Symptoms of Depression
Timepoint [7] 433102 0
Baseline, post intervention, 3-month follow up
Secondary outcome [8] 433103 0
Symptoms of Anxiety
Timepoint [8] 433103 0
Baseline, post intervention, 3-month follow up
Secondary outcome [9] 433104 0
Symptoms of Stress
Timepoint [9] 433104 0
Baseline, post intervention, 3-month follow up

Eligibility
Key inclusion criteria
Participants will be adults with a diagnosis of endometriosis by a qualified physician (confirmed by histology, operation reports, and/or ultrasound scan), capacity for consent, sufficient level of English to understand the intervention and be able answer relevant questionnaires via internet (individually or with support).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with severe psychological distress (>30 as measured by the Kessler Psychological Distress Scale (K10) and those who have completed an acceptance and commitment therapy-based intervention or treatment program within the last 6 months will be excluded and provided with external support resources.

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)
A block randomisation sequence with variable block size will be embedded in Qualtrics by the study biostatistician for allocation concealment. The biostatistician will not be involved in participant recruitment and will be blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consenting participants will be randomly assigned (1:1 ratio) to ACTforEndo or wait list control following completion of baseline questionnaires. A block randomisation sequence with variable block size will be embedded in Qualtrics for allocation concealment. The biostatistician will be blinded to allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All statistical analyses will be conducted on an intention-to-treat basis. The intervention effect at 6-weeks and at 3 months on the primary outcomes and the secondary outcomes will be estimated using linear mixed models. The models will include study arm, time (T1, T2, T3) and time by study arm interaction as fixed effects, and participant as random effect. Reasons for non-completion will be collected. Multiple imputation will be used for missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315359 0
University
Name [1] 315359 0
Deakin University
Country [1] 315359 0
Australia
Funding source category [2] 315565 0
Government body
Name [2] 315565 0
National Health and Medical Research Council
Country [2] 315565 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Melbourne Burwood Campus, 221 Burwood Highway Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 317656 0
None
Name [1] 317656 0
Address [1] 317656 0
Country [1] 317656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314278 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 314278 0
Human Research Ethics Office Deakin University 221 Burwood Hwy Burwood, VIC 3125
Ethics committee country [1] 314278 0
Australia
Date submitted for ethics approval [1] 314278 0
19/06/2023
Approval date [1] 314278 0
20/07/2023
Ethics approval number [1] 314278 0

Summary
Brief summary
Endometriosis is a chronic condition in which tissue similar to that lining the uterus grows on other organs, leading to scarring and adhesions and causing pain, menstrual irregularities, and infertility. Impacting 11% of Australian women and those assigned female at birth, endometriosis is under-recognised due to the variability in symptoms, reliance on surgery for diagnosis, and stigma of menstruation. Usual care, comprising of hormone and pain medications, has limited efficacy, is associated with adverse effects, and is discontinued by up to 40% of people.
Recognising the inadequacy of the current biomedical healthcare approach to treating endometriosis, there is a need to address the complex biopsychosocial burden of endometriosis.

The current project will be a small feasibility pilot trial to explore whether an adapted, online Acceptance and Commitment Therapy intervention is feasible and acceptable for this population. This study will form a part of a larger study (i.e., CoDeEndo, a hybrid type 1 efficacy and implementation randomised controlled trial evaluating a highly novel online multi-modular supportive care program for Australian adults living with endometriosis) for which ethics approval will be sought once this study is near completion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131034 0
Ms Suiyin Cheah
Address 131034 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 131034 0
Australia
Phone 131034 0
+61 412514910
Fax 131034 0
Email 131034 0
cheahs@deakin.edu.au
Contact person for public queries
Name 131035 0
Ms Suiyin Cheah
Address 131035 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 131035 0
Australia
Phone 131035 0
+61 412514910
Fax 131035 0
Email 131035 0
cheahs@deakin.edu.au
Contact person for scientific queries
Name 131036 0
Prof Antonina Mikocka-Walus
Address 131036 0
Deakin University School of Psychology 221 Burwood Hwy Burwood 3125 VIC
Country 131036 0
Australia
Phone 131036 0
+61392468575
Fax 131036 0
Email 131036 0
mikocka@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We believe participants (a chronically ill cohort) may be reluctant to participate if we decided to share their health-related data. Further, we are initiating a program of research in this area and want our team to be able to use the data in future publications. This is not a large dataset and thus by opening it to others we might lose the opportunity to publish the data ourselves.


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.