EndometriosisNCT02761382
Psychological Pain Treatment in Endometriosis
A study testing Mindfulness-based psychological treatment and Non-specific psychological treatment in people with Endometriosis and Pelvic Pain, run by University of Aarhus at 3 sites in Denmark.
Trial summary
This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women only
- Conditions the study is for
- Endometriosis, Pelvic Pain, Chronic Pain
- What is being tested?
- Mindfulness-based psychological treatment and Non-specific psychological treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2016to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Endometriosis diagnosed by laparoscopy or MRI.
- Moderate to severe endometriosis-related chronic pelvic pain.
- Relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis have been tried.
Who cannot join
- Fibromyalgia, Colitis Chron or Colitis Ulcerosa
- Severe psychiatric diagnosis
- Pregnancy or planned pregnancy during the study period
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aarhus University Hospital, Department of Obstetrics and Gynecology
Aarhus N, 8200
Copenhagen University Hospital, Department of Gynaecology
Copenhagen, 2100
North Denmark Regional Hospital
Hjørring
About this study
Official title: Mindfulness-based Psychological Pain Treatment in Endometriosis
This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).
- Conditions
- Endometriosis, Pelvic Pain, Chronic Pain
- Being tested
- Mindfulness-based psychological treatment, Non-specific psychological treatment
- Medical subject headings
- Endometriosis, Pelvic Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based psychological treatmentOther
Non-specific psychological treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based treatment | Experimental | The mindfulness-based psychological treatment consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Mindfulness-based stress reduction (MBSR), Mindfulness-based cognitive therapy (MBCT) and Acceptance and commitment therapy (ACT). The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include:
1. mindfulness-training (including meditation and yoga),
2. therapy based on ACT, and
3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain. Receives: Other: Mindfulness-based psychological treatment |
| Non-specific treatment | Experimental | The non-specific general psychological treatment is matched the mindfulness-based psychological treatment and consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Client-centered therapy. The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include:
1. relaxation and physical training,
2. therapy based on the non-specific factors of psychological treatment which emphasize a focus on the relation and alliance between the therapist and the client and the therapist being a warm empathic, non-directive and unconditionally accepting support, and
3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain. Receives: Other: Non-specific psychological treatment |
| Waiting list control | No intervention | Participants in this arm will be on the waiting list to participate in one of the two experimental treatments after a period of six months. Participants will receive medical treatment as usual in this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic pain measured on Numeric Rating Scale
Pain intensity (sensory) and pain unpleasantness (affective) will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a daily pain diary.
Measured: Change from pre-intervention to post-intervention (12 weeks)
Secondary outcomes (5)
Quality of life measured by the Endometriosis Health Profile 30 questionnaire
Quality of life will be measured by the Endometriosis Health Profile 30 questionnaire (EHP-30) which is a patient generated questionnaire that measure endometriosis-related quality of life
Measured: Change from pre-intervention to post-intervention (12 weeks)
Endometriosis related symptoms measured on Numeric Rating Scale
Dyspareunia, Dysmenorrhea, Dyschezia, Dysuria, Tiredness, Constipation, Diarrhea, Nausea and Vomiting will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a weekly diary.
Measured: Change from pre-intervention to post-intervention (12 weeks)
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Measured: Change from pre-intervention to post-intervention (12 weeks)
Work Ability measured by the Work Ability Index
Work ability will be measured by the Work Ability Index (WAI) which is a questionnaire used to measure changes in work ability due to a specific intervention
Measured: Change from pre-intervention to post-intervention (12 weeks)
Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)
Vaginal pressure pain detection threshold (PPDT) will be examined with a modified pressure algometer (palpometer) applicable for intravaginal pelvic floor muscle examination.
Measured: Change from pre-intervention to post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, TrygFonden, Denmark, Copenhagen University Hospital, Denmark, Endometriose Foreningen
- Responsible party
- Sponsor
- Investigators
- Axel Forman, Study chair, Aarhus University HospitalLene Vase, Study director, University of AarhusKarina E Hansen, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761382
- Sponsor's protocol ID
- AUENDO
- Status last verified
- Jun 2018
- First submitted
- 12 Apr 2016
- Last updated
- 18 May 2022
- Results posted
- No
Publications
Hansen KE, Brandsborg B, Kesmodel US, Forman A, Kold M, Pristed R, Donchulyesko O, Hartwell D, Vase L. Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial. Qual Life Res. 2023 Jun;32(6):1727-1744. doi: 10.1007/s11136-023-03346-9. Epub 2023 Feb 17.
PubMed 36797461
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Psychological Pain Treatment in Endometriosis
- ClinicalTrials.gov ID
- NCT02761382
- Acronym / sponsor ID
- AUENDO
- Conditions
- Endometriosis, Pelvic Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, TrygFonden, Denmark, Copenhagen University Hospital, Denmark, Endometriose Foreningen
- Study start
- Mar 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of psychological treatment on pain, quality of life and work ability among women with endometriosis related chronic pelvic pain in a three-armed, randomised study. One group will receive mindfulness-based psychological treatment, the second group will receive a non-specific general psychological treatment (a psychological placebo) and the third group will be a waiting list control (treatment as usual).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based treatment | Experimental | Other: Mindfulness-based psychological treatmentThe mindfulness-based psychological treatment consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Mindfulness-based stress reduction (MBSR), Mindfulness-based cognitive therapy (MBCT) and Acceptance and commitment therapy (ACT). The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include: 1. mindfulness-training (including meditation and yoga), 2. therapy based on ACT, and 3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain. |
| Non-specific treatment | Experimental | Other: Non-specific psychological treatmentThe non-specific general psychological treatment is matched the mindfulness-based psychological treatment and consists of 10 weekly group sessions of 3 hours duration. The treatment is based on Client-centered therapy. The intervention is partly manualized to accommodate demands of methodology, accuracy and repeatability. The group sessions will include: 1. relaxation and physical training, 2. therapy based on the non-specific factors of psychological treatment which emphasize a focus on the relation and alliance between the therapist and the client and the therapist being a warm empathic, non-directive and unconditionally accepting support, and 3. patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain. |
| Waiting list control | No intervention | –Participants in this arm will be on the waiting list to participate in one of the two experimental treatments after a period of six months. Participants will receive medical treatment as usual in this period. |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Endometriosis diagnosed by laparoscopy or MRI.
- Moderate to severe endometriosis-related chronic pelvic pain.
- Relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis have been tried.
Key exclusion criteria (3 listed)
- Fibromyalgia, Colitis Chron or Colitis Ulcerosa
- Severe psychiatric diagnosis
- Pregnancy or planned pregnancy during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based psychological treatment | Other | Mindfulness-based treatment |
| Non-specific psychological treatment | Other | Non-specific treatment |
Primary outcome
Pelvic pain measured on Numeric Rating Scale
Time frame: Change from pre-intervention to post-intervention (12 weeks)
Pain intensity (sensory) and pain unpleasantness (affective) will be measured on Numeric Rating Scale (NRS: 0 = no pain till 10 = worst pain imaginable) in a daily pain diary.
5 secondary outcomes
Quality of life measured by the Endometriosis Health Profile 30 questionnaire
Time frame: Change from pre-intervention to post-intervention (12 weeks)
Endometriosis related symptoms measured on Numeric Rating Scale
Time frame: Change from pre-intervention to post-intervention (12 weeks)
Pain acceptance measured by Chronic Pain Acceptance Questionnaire
Time frame: Change from pre-intervention to post-intervention (12 weeks)
Work Ability measured by the Work Ability Index
Time frame: Change from pre-intervention to post-intervention (12 weeks)
Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)
Time frame: Change from pre-intervention to post-intervention (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 36797461Hansen KE, Brandsborg B, Kesmodel US, Forman A, Kold M, Pristed R, Donchulyesko O, Hartwell D, Vase L. Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial. Qual Life Res. 2023 Jun;32(6):1727-1744. doi: 10.1007/s11136-023-03346-9. Epub 2023 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Forman study chair
Aarhus University Hospital
Lene Vase study director
University of Aarhus
Karina E Hansen principal investigator
University of Aarhus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based psychological treatment and Non-specific psychological treatment in people with Endometriosis and Pelvic Pain, run by University of Aarhus at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic pain measured on Numeric Rating Scale (time frame: Change from pre-intervention to post-intervention (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.