Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2016-03-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mindfulness-based treatment
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.
Mindfulness-based psychological treatment
Non-specific treatment
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.
Non-specific psychological treatment
Waiting list control
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.
No interventions assigned to this group
Interventions
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Mindfulness-based psychological treatment
Non-specific psychological treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe psychiatric diagnosis
* Pregnancy or planned pregnancy during the study period
18 Years
47 Years
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
TrygFonden, Denmark
INDUSTRY
Copenhagen University Hospital, Denmark
OTHER
Endometriose Foreningen
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Axel Forman
Role: STUDY_CHAIR
Aarhus University Hospital
Lene Vase
Role: STUDY_DIRECTOR
University of Aarhus
Karina E Hansen
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University Hospital, Department of Obstetrics and Gynecology
Aarhus N, , Denmark
Copenhagen University Hospital, Department of Gynaecology
Copenhagen, , Denmark
North Denmark Regional Hospital
Hjørring, , Denmark
Countries
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References
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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.
Other Identifiers
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AUENDO
Identifier Type: -
Identifier Source: org_study_id
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