Psychological Pain Treatment in Endometriosis

University of Aarhus

Status: Completed

Conditions: Pelvic Pain; Chronic Pain; Endometriosis

Treatments: Other: Mindfulness-based psychological treatment; Other: Non-specific psychological treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02761382

AUENDO

Details and patient eligibility

About

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).

Enrollment: 58 patients

Sex: Female

Ages: 18 to 47 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

58 participants in 3 patient groups

Mindfulness-based treatment

Experimental group

Description:

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.

Treatment:

Other: Mindfulness-based psychological treatment

Non-specific treatment

Experimental group

Description:

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.

Treatment:

Other: Non-specific psychological treatment

Waiting list control

No Intervention group

Description:

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.