Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial

K. E. Hansen; B. Brandsborg; U. S. Kesmodel; A. Forman; M. Kold; R. Pristed; O. Donchulyesko; D. Hartwell; L. Vase

doi:10.1007/s11136-023-03346-9

Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial

K. E. Hansen^*, B. Brandsborg, U. S. Kesmodel, A. Forman, M. Kold, R. Pristed, O. Donchulyesko, D. Hartwell, L. Vase

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

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Abstract

PURPOSE: Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis.

METHODS: This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0-10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis.

RESULTS: Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales 'control and powerlessness', 'emotional well-being', and 'social support' as well as the endometriosis-related symptoms 'dyschezia' and 'constipation'. MY-ENDO was not superior to Non-specific.

CONCLUSIONS: Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.

TRIAL REGISTRATION: 12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered.

Original language	English
Journal	Quality of Life Research
Volume	32
Issue number	6
Pages (from-to)	1727–1744
Number of pages	18
ISSN	0962-9343
DOIs	https://doi.org/10.1007/s11136-023-03346-9
Publication status	Published - Jun 2023

Bibliographical note

Keywords

Acceptance and commitment therapy
Chronic pelvic pain
Control condition
Endometriosis
Mindfulness
Psychotherapy
Quality of life
Humans
Pelvic Pain/therapy
Psychosocial Intervention
Quality of Life/psychology
Emotions
Endometriosis/complications
Female

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Hansen, K. E., Brandsborg, B., Kesmodel, U. S., Forman, A., Kold, M., Pristed, R., Donchulyesko, O., Hartwell, D., & Vase, L. (2023). Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial. Quality of Life Research, 32(6), 1727–1744. Advance online publication. https://doi.org/10.1007/s11136-023-03346-9

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title = "Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial",

abstract = "PURPOSE: Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis.METHODS: This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0-10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis.RESULTS: Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales 'control and powerlessness', 'emotional well-being', and 'social support' as well as the endometriosis-related symptoms 'dyschezia' and 'constipation'. MY-ENDO was not superior to Non-specific.CONCLUSIONS: Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.TRIAL REGISTRATION: 12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered.",

keywords = "Acceptance and commitment therapy, Chronic pelvic pain, Control condition, Endometriosis, Mindfulness, Psychotherapy, Quality of life, Humans, Pelvic Pain/therapy, Psychosocial Intervention, Quality of Life/psychology, Emotions, Endometriosis/complications, Female",

author = "Hansen, {K. E.} and B. Brandsborg and Kesmodel, {U. S.} and A. Forman and M. Kold and R. Pristed and O. Donchulyesko and D. Hartwell and L. Vase",

note = "{\textcopyright} 2023. The Author(s).",

year = "2023",

month = jun,

doi = "10.1007/s11136-023-03346-9",

language = "English",

volume = "32",

pages = "1727–1744",

journal = "Quality of Life Research",

issn = "0962-9343",

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TY - JOUR

T1 - Psychological interventions improve quality of life despite persistent pain in endometriosis

T2 - results of a 3-armed randomized controlled trial

AU - Hansen, K. E.

AU - Brandsborg, B.

AU - Kesmodel, U. S.

AU - Forman, A.

AU - Kold, M.

AU - Pristed, R.

AU - Donchulyesko, O.

AU - Hartwell, D.

AU - Vase, L.

PY - 2023/6

Y1 - 2023/6

N2 - PURPOSE: Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis.METHODS: This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0-10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis.RESULTS: Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales 'control and powerlessness', 'emotional well-being', and 'social support' as well as the endometriosis-related symptoms 'dyschezia' and 'constipation'. MY-ENDO was not superior to Non-specific.CONCLUSIONS: Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.TRIAL REGISTRATION: 12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered.

AB - PURPOSE: Despite standard medical treatment endometriosis is often associated with disabling pain and poor quality of life (QoL). Studies indicate that psychological interventions (PIs) may improve pain and QoL, yet studies on the effects of PIs for women with endometriosis are sparse and limited by low-quality study designs. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis.METHODS: This three-armed parallel, multi-center randomized controlled trial included fifty-eight endometriosis patients reporting severe CPP [≥ 5 for pain intensity measured on a 0-10-point numeric rating scale (NRS)]. Patients were randomly assigned to (1) Specific mindfulness- and acceptance-based psychological intervention (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis.RESULTS: Compared to WL, psychological intervention (MY-ENDO + Non-specific) did not significantly reduce pain. However, psychological intervention did significantly improve the QoL-subscales 'control and powerlessness', 'emotional well-being', and 'social support' as well as the endometriosis-related symptoms 'dyschezia' and 'constipation'. MY-ENDO was not superior to Non-specific.CONCLUSIONS: Women with endometriosis may have significant and large effects of psychological intervention on QoL despite an ongoing experience of severe CPP.TRIAL REGISTRATION: 12 April 2016, clinicaltrials.gov (NCT02761382), retrospectively registered.

KW - Acceptance and commitment therapy

KW - Chronic pelvic pain

KW - Control condition

KW - Endometriosis

KW - Mindfulness

KW - Psychotherapy

KW - Quality of life

KW - Humans

KW - Pelvic Pain/therapy

KW - Psychosocial Intervention

KW - Quality of Life/psychology

KW - Emotions

KW - Endometriosis/complications

KW - Female

U2 - 10.1007/s11136-023-03346-9

DO - 10.1007/s11136-023-03346-9

M3 - Journal article

C2 - 36797461

AN - SCOPUS:85148112664

SN - 0962-9343

VL - 32

SP - 1727

EP - 1744

JO - Quality of Life Research

JF - Quality of Life Research

IS - 6

ER -

Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial

Abstract

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