Psychological Pain Treatment in Endometriosis

NCT02761382 | Completed

• 1 other identifier: AUENDO
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of life measured by the Endometriosis Health Profile 30 questionnaire

  Change from pre-intervention to post-intervention (12 weeks)

• Endometriosis related symptoms measured on Numeric Rating Scale

  Change from pre-intervention to post-intervention (12 weeks)

• 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

  Change from pre-intervention to post-intervention (12 weeks)

• Vaginal pressure pain detection threshold (PPDT) examined with a modified pressure algometer (palpometer)

  Change from pre-intervention to post-intervention (12 weeks)

Other Outcomes (2)

• Psychological flexibility measured by the Acceptance and Action Questionnaire-II

  Change from pre-intervention to post-intervention (12 weeks)

• Mindfulness measured by the Five Facet Mindfulness Questionnaire

  Change from pre-intervention to post-intervention (12 weeks)

Study Arms (3)

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.

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.

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.

Interventions

Mindfulness-based psychological treatment OTHER

Mindfulness-based treatment

Non-specific psychological treatment OTHER

Non-specific treatment

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Fibromyalgia, Colitis Chron or Colitis Ulcerosa
• Severe psychiatric diagnosis
• Pregnancy or planned pregnancy during the study period

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• TrygFonden, Denmark: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Endometriose Foreningen: collaborator

Study Sites (3)

Aarhus University Hospital, Department of Obstetrics and Gynecology

Aarhus N, 8200, Denmark

Location

Copenhagen University Hospital, Department of Gynaecology

Copenhagen, 2100, Denmark

Location

North Denmark Regional Hospital

Hjørring, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36797461 DERIVED

MeSH Terms

Conditions

Endometriosis; Pelvic Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Axel Forman

  Aarhus University Hospital

  STUDY CHAIR

• Lene Vase

  University of Aarhus

  STUDY DIRECTOR

• Karina E Hansen

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: May 4, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 18, 2022

Record last verified: 2018-06

Locations

DK (3)