Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000756921
Ethics application status
Approved
Date submitted
10/06/2020
Date registered
22/07/2020
Date last updated
2/06/2022
Date data sharing statement initially provided
22/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the influence of Yoga, Cognitive Behaviour Therapy and Standard Care on Quality of Life and Healthcare Costs in Endometriosis
Scientific title
A Randomised Controlled Trial Comparing the influence of Yoga, Cognitive Behaviour Therapy and Standard Care on Quality of Life and Healthcare Costs in women with Endometriosis
Secondary ID [1] 301443 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HaPPI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 317750 0
Pain 317751 0
Fatigue 317752 0
Condition category
Condition code
Reproductive Health and Childbirth 315816 315816 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial tests yoga and cognitive-behavioural therapy (CBT)

CBT for chronic pain: Participants randomized to CBT will attend 8 weekly group CBT sessions of 120 minutes (minimum 10, max 13 participants/group) either in person or online, delivered by provisional psychologists under the supervision of a senior psychologist. The program draws on Beverly Thorn’s widely available CBT protocol for pain. The program aims to assist individuals to: gain an understanding of pain including education about chronic pain; learn practical strategies for managing pain and mood; practice the techniques both in and outside of the group setting, and; and learn how to maintain the gains they have made during therapy and prevent relapse. Participants will be encouraged to complete 20 min home practice (at least 3 days/week) involving working through the techniques introduced during sessions led by the therapist. The task for each week will be distributed via email. Adherence to the intervention will be monitored with attendance checklists.

Yoga therapy: Participants randomized to yoga will attend 8 weekly group yoga sessions of 60 minutes (minimum 10, maximum 13 participants/group) either in person or online. Classes include: physical postures (suitable for all levels of experience, with adjustments for individual physical fitness and health issues); breath awareness and techniques; and relaxation and meditation.
The yoga sequence will be based on vinyasa yoga in the tradition of T. Krishnamacharya, which emphasizes adaptations for health conditions. Classes will be led by experienced yoga therapists. Adherence to the intervention will be monitored with attendance checklists. Before beginning classes, participants will attend a 60 minutes session with the yoga therapist to develop their home practice schedule, accounting for any injuries or health issues. Participants will be encouraged to complete 20 min home practice (at least 3 days/week)- involving simple movement and breathing techniques, with the aim of setting a new positive pattern for participants to continue after study completion. These sessions will be monitored for the duration of the intervention. Patient’s home practice fidelity and adherence will be measured with a logbook.
Intervention code [1] 317756 0
Behaviour
Intervention code [2] 317757 0
Lifestyle
Intervention code [3] 317758 0
Treatment: Other
Comparator / control treatment
standard care + education

In addition to standard medical care (e.g. hormones, SSRIs, SNRIs and TCAs such as amitriptyline), the control group will receive standardised educational care, consisting of weekly educational handouts on endometriosis. This is consistent with endometriosis education patients receive from their treating physician. Eight weekly topics align with 8 topics: symptoms, diagnosis, management, fertility, emotions complications, relationships and endo stories. These materials will be delivered to participants via email. At 12 months, patients will be offered their choice of yoga or CBT. These participants will not be followed up after they start the intervention.
Control group
Active

Outcomes
Primary outcome [1] 324022 0
Endometriosis-related quality of life measured by the 30-item endometriosis Health Profile (EHP-30)
Timepoint [1] 324022 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Primary outcome [2] 324023 0
Generic quality of life measured by the EQ-5D
Timepoint [2] 324023 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [1] 383567 0
Pain measured by with the Brief Pain Inventory
Timepoint [1] 383567 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [2] 383568 0
Depression measured by the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [2] 383568 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [3] 383569 0
Anxiety measured by the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [3] 383569 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [4] 383570 0
Stress measured by the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [4] 383570 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [5] 383571 0
Fatigue measured by the Fatigue Symptom Inventory
Timepoint [5] 383571 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [6] 383572 0
Treatment satisfaction measured with a 4-point satisfaction scale designed specifically for this study.
Timepoint [6] 383572 0
Post-treatment at 8 weeks
Secondary outcome [7] 383573 0
Patient health service utilisation measured by a patient health service utilisation questionnaire designed specifically for this study
Timepoint [7] 383573 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [8] 383574 0
Adverse events measured by a patient self-report measure after the intervention, and ongoing informal monitoring from the intervention therapists using a study-specific questionnaire. Adverse events for CBT are very rare but can include deterioration of mental health, new psychological symptoms, and distress. Adverse events of yoga could involve musculoskeletal effects such as sprains and strains.
Timepoint [8] 383574 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [9] 384213 0
Employment measured by an employment questionnaire developed specifically for this study
Timepoint [9] 384213 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [10] 384214 0
Participant feedback regarding the intervention and the planned dissemination strategies will be collected by semi-structured audio-recorded group interviews with a random selection of 10 participants in the yoga and CBT groups (total n=20). The aim of the interviews is to understand perceived barriers and enablers to CBT and yoga, and patients’ most significant change.
Timepoint [10] 384214 0
8 weeks
Secondary outcome [11] 396905 0
Pain Catastrophising will be measured with the 13 point standardised 'Pain Catastrophizing Scale'.
Timepoint [11] 396905 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline
Secondary outcome [12] 396906 0
Sleep will be assessed using the four-item 'Jenkins Sleep Scale'.
Timepoint [12] 396906 0
Baseline, post-treatment at 8 weeks, 6 and 12 months since baseline

Eligibility
Key inclusion criteria
Diagnosis of endometriosis or suspected endometriosis by a physician, with pain for at least 6 months. For patients recruited via support groups, they will need to provide their histology and operation report.

Other inclusion criteria are: English speaking; capacity to provide informed consent, not currently pregnant, have no major physical issues or injuries, and have not recently completed a course of therapist led yoga or CBT.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk of harming self or others or unsuitable for group treatment (e.g. severe mental illness/addiction or cognitive impairment), as confirmed during psychological screening.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the holder of the allocation schedule (the study statistician) who is based at central administration site with no access to participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created using computer software by the study statistician who has no direct patient contact.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Blinding the treatment groups is not possible as is often the case in psychotherapy and mind-body trials. However, outcome measures will be collected by a blinded researcher, and the investigators will be blinded to participant allocation, making it a single-blinded study.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The data will be analysed using mixed-effects ANOVA and linear models to identify change over time within and between groups, followed by post-hoc analyses to identify statistically significant differences. Analyses will be carried out on intention-to-treat basis. To reduce bias, the statistician analysing the data will be blind to group allocation during the data analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
23/04/2021
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
259
Accrual to date
179
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 16837 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 16839 0
Epworth Freemasons (Victoria Parade) - East Melbourne
Recruitment hospital [3] 16842 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 30480 0
3002 - East Melbourne
Recruitment postcode(s) [2] 30487 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 30478 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 305879 0
Government body
Name [1] 305879 0
MRFF EPCDR Endometriosis 2020
Country [1] 305879 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood 3125 VIC
Country
Australia
Secondary sponsor category [1] 306334 0
None
Name [1] 306334 0
None
Address [1] 306334 0
None
Country [1] 306334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306139 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 306139 0
221 Burwood Highway, 3125 Burwood, VIC
Ethics committee country [1] 306139 0
Australia
Date submitted for ethics approval [1] 306139 0
30/09/2020
Approval date [1] 306139 0
18/11/2020
Ethics approval number [1] 306139 0
Ethics committee name [2] 306141 0
Barwon Health Research Ethics, Governance & Integrity Unit (REGI)
Ethics committee address [2] 306141 0
PO Box 281
Geelong VIC 3220
Ethics committee country [2] 306141 0
Australia
Date submitted for ethics approval [2] 306141 0
31/08/2020
Approval date [2] 306141 0
04/11/2020
Ethics approval number [2] 306141 0
Ethics committee name [3] 308772 0
Monash Health Human Research Ethics Committee
Ethics committee address [3] 308772 0
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton, Victoria. 3168
Ethics committee country [3] 308772 0
Australia
Date submitted for ethics approval [3] 308772 0
14/12/2020
Approval date [3] 308772 0
22/01/2021
Ethics approval number [3] 308772 0
RES-20-0000-838X

Summary
Brief summary
Afflicting more people than breast and prostate cancer, diabetes, and AIDS combined, endometriosis is a highly burdensome disease costing Australians more than $7.7 billion. In addition to pain, common symptoms include fatigue, anxiety and depression, and reduced quality of life (QoL). Poor psychological prognosis has led to urgent calls for treatments that address mental health to prevent further degradations in QoL. We will evaluate the efficacy and cost effectiveness of 1) yoga, and 2) cognitive behaviour therapy (CBT), compared to 3) standard care receiving patient education. Our systematic review identified that yoga and CBT hold promise in improving pain and mental health in endometriosis. Yoga is likely to improve wellbeing via the benefits of movement, and relaxation through breath regulation and meditation, potentially benefiting inflammation, stress, pain, and emotion regulation. CBT is purported to improve QoL by correcting maladaptive thoughts, developing self-efficacy and coping, and increasing engagement in life tasks. However, thus far only pilot studies exist. We propose a step change in our understanding of the potential impact of yoga and CBT by undertaking a full-scale randomised controlled trial using gold-standard methodology. We will provide high quality evidence for CBT and yoga and their impact on endometriosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102846 0
A/Prof Subhadra Evans
Address 102846 0
School of Psychology
Deakin University
221 Burwood Highway
3125 Burwood VIC
Country 102846 0
Australia
Phone 102846 0
+61 3 924 46270
Fax 102846 0
Email 102846 0
subhadra.evans@deakin.edu.au
Contact person for public queries
Name 102847 0
Mrs Elesha Parigi
Address 102847 0
School of Psychology Deakin University 1-11 Gheringhap Street Geelong VIC 3220
Country 102847 0
Australia
Phone 102847 0
+61 3 5227 8133
Fax 102847 0
Email 102847 0
thehappistudy@deakin.edu.au
Contact person for scientific queries
Name 102848 0
A/Prof Subhadra Evans
Address 102848 0
School of Psychology
Deakin University
221 Burwood Highway
3125 Burwood VIC
Country 102848 0
Australia
Phone 102848 0
+61 3 924 46270
Fax 102848 0
Email 102848 0
subhadra.evans@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) might 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12104Ethical approval    379947-(Uploaded-04-11-2020-12-29-29)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.