Psychological Pain Treatment in Endometriosis

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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.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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