Psychological Pain Treatment in Endometriosis

Study Overview
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Brief Summary
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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).

Official Title
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Mindfulness-based Psychological Pain Treatment in Endometriosis

Conditions
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Endometriosis, Pelvic Pain, Chronic Pain

Intervention / Treatment
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* Other: Mindfulness-based psychological treatment
* Other: Non-specific psychological treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Fibromyalgia, Colitis Chron or Colitis Ulcerosa Severe psychiatric diagnosis Pregnancy or planned pregnancy during the study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 47 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based treatment<br>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: mindfulness-training (including meditation and yoga), therapy based on ACT, and patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain. | Other: Mindfulness-based psychological treatment<br> <br> |
| Experimental: Non-specific treatment<br>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: relaxation and physical training, 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 patient-education in themes specifically targeted living with endometriosis-related chronic pelvic pain. | Other: Non-specific psychological treatment<br> <br> |
| No Intervention: Waiting list control<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from pre-intervention to post-intervention (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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 | 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. | Change from pre-intervention to post-intervention (12 weeks) |