Protective Factors for Well-being in Endometriosis Patients

NCT07854925 | Not Yet Recruiting

• 2 other identifiers: 2026-00695PZ00-1_233235
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endometriosis is a common chronic condition in which tissue resembling the lining of the uterus grows outside the uterus. It affects up to 10% of all women, causes severe pain, and places a significant burden on those affected. Current treatments often provide insufficient relief, and the impact of psychosocial factors on the well-being of those affected has received little research attention to date. With this study, the investigators aim to improve the well-being of women with endometriosis. To this end, the investigators have developed the EMPOWER intervention, a couple-based program designed to enhance well-being. The intervention is intended to alleviate pain, improve well-being, and help both partners cope better with the condition. The findings will be published in a free self-help manual intended to benefit those affected worldwide.

Conditions

Endometriosis

Keywords

Endometriosis; Women's health; Mindfulness; Partner Support; Well-being

Outcome Measures

Primary Outcomes (4)

• WHO-5 Well-Being Index (World Health Organization, 1998)

  Six-point Likert scale ("0 = Never" - "5 = All the time"); higher scores indicate higher levels of well-being.

  Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.

• Diurnal Salivary Cortisol Slope (nmol/L; Psychobiological Stress Regulation)

  Salivary cortisol concentration (nmol/L) from four self-collected saliva samples per day (60 minutes after awakening, 2.5 hours later, 8 hours later, and at bedtime); the diurnal slope is calculated as the rate of decline from the morning peak to the evening nadir; steeper negative slopes indicate healthier hypothalamic-pituitary-adrenal (HPA) axis regulation.

  On two consecutive days pre-intervention; on the six intervention days, four samples per day.

• Current pain Intensity (Numeric Rating Scale)

  11-point Likert scale ("0 = No Pain" - "10 = Strongest imaginable pain" ); higher scores indicate higher levels of pain.

  Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.

• Relationship Assessment Scale (RAS; Hendrick, 1988)

  Five-point Likert scale ("0 = Very dissatisfied" - "4 = Very satisfied"; phrasing varies by item); higher scores indicate higher relationship satisfaction.

  Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.

Secondary Outcomes (10)

• Satisfaction with Life Scale (SWLS; Diener et al., 1985)

  Baseline; one month post-intervention; seven months post-intervention.

• Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008)

  Baseline; one month post-intervention; seven months post-intervention.

• Practical and Emotional Support Provision and Receipt (Shrout et al., 2006)

  Baseline; one month post-intervention; seven months post-intervention.

• Endometriosis Health Profile-30 (EHP-30; Jones et al., 2001)

  Baseline; one month post-intervention; seven months post-intervention.

• Endometriosis Pain and Bleeding Diary (Deal et al., 2010)

  Baseline; one month post-intervention; seven months post-intervention.

Other Outcomes (15)

• Dyadic Coping Inventory (DCI; Bodenmann, 1997)

  Baseline; one month post-intervention; seven months post-intervention.

• Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011)

  Baseline; one month post-intervention; seven months post-intervention.

• State Mindfulness Scale (SMF; Van Der Gucht et al., 2019)

  Immediately before and after each intervention session.

Study Arms (2)

Control

ACTIVE COMPARATOR

Behavioral: Control

EMPOWER-Intervention

EXPERIMENTAL

Behavioral: EMPOWER

Interventions

EMPOWER BEHAVIORAL

The EMPOWER intervention consists of six 30-60 minute couple sessions (3x per week over two weeks), conducted at home via guided audio. Each session combines a structured mindfulness exercise (progressing difficulty) with a mutual partner support conversation (structured speaker-listener format, progressing difficulty).

EMPOWER-Intervention

Control BEHAVIORAL

The active control condition consists of six sessions of similar length, comprising psychoeducation about endometriosis and chronic pain, unguided relaxation to music, and less structured couple conversations without the partner support component.

Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically confirmed endometriosis diagnosis
• subjective impact on well-being
• currently in a relationship
• both partners willing to participate
• fluency in German
• residency in German-speaking Switzerland
• ability to provide informed consent

You may not qualify if:

• self-diagnosed endometriosis
• asymptomatic endometriosis
• single individuals
• only one partner willing to participate
• no access to a mobile device
• pregnancy

Sponsors & Collaborators

• Maximiliane Uhlich: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Maximiliane Uhlich, PhD

  University of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maximiliane Uhlich, PhD

CONTACT

+41 61 207 82 85; maximiliane.uhlich@unibas.ch

Simone Wyss, MSc

CONTACT

si.wyss@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share