Protective Factors for Well-being in Endometriosis Patients
ConditionEndometriosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMaximiliane Uhlich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
clinically confirmed endometriosis diagnosis
subjective impact on well-being
currently in a relationship
both partners willing to participate
Disqualifiers
self-diagnosed endometriosis
asymptomatic endometriosis
single individuals
only one partner willing to participate
Trial design
Design model
Parallel
Treatments tested in this trial
EMPOWER
BehavioralThe 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).
Control
BehavioralThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: EMPOWER-InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.2
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.
Time frame
On two consecutive days pre-intervention; on the six intervention days, four samples per day.3
Current pain Intensity (Numeric Rating Scale)
11-point Likert scale ("0 = No Pain" - "10 = Strongest imaginable pain" ); higher scores indicate higher levels of pain.
Time frame
Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.4
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.
Time frame
Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.Secondary outcomes
1
Satisfaction with Life Scale (SWLS; Diener et al., 1985)
Five-point Likert scale ("0 = Not at all true" - "4 = Completely true"); higher scores indicate higher levels of life satisfaction.
Time frame
Baseline; one month post-intervention; seven months post-intervention.2
Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008)
Five-point Likert scale ("0 = Never or very rarely true" - "4 = Very often or almost always true"); higher scores indicate higher levels of mindfulness.
Time frame
Baseline; one month post-intervention; seven months post-intervention.3
Practical and Emotional Support Provision and Receipt (Shrout et al., 2006)
Six-point Likert scale ("0 = Never" - "5 = Very often"); higher scores indicate higher levels of support.
Time frame
Baseline; one month post-intervention; seven months post-intervention.4
Endometriosis Health Profile-30 (EHP-30; Jones et al., 2001)
Six-point Likert scale ("0 = Never" - "5 = Always"); higher scores indicate higher levels of pain impact and dysfunction.
Time frame
Baseline; one month post-intervention; seven months post-intervention.Other outcomes
1
Dyadic Coping Inventory (DCI; Bodenmann, 1997)
Five-point Likert scale ("0 = Never" - "4 = Very often"); higher scores indicate higher levels of dyadic support.
Time frame
Baseline; one month post-intervention; seven months post-intervention.2
Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011)
Five-point Likert scale ("0 = Almost never" - "4 = "Almost always"); higher scores indicate higher levels of self-compassion.
Time frame
Baseline; one month post-intervention; seven months post-intervention.3
State Mindfulness Scale (SMF; Van Der Gucht et al., 2019)
Five-point Likert scale ("0 = Not at all true" - "4 = Completely true"); higher scores indicate higher levels of state mindfulness.
Time frame
Immediately before and after each intervention session.4
Support Evaluation (Langer et al., 2022)
Six-point Likert scale ("0 = Not at all" - "5 = Very strongly/Completely"); higher scores indicate higher levels of perceived support.
Time frame
Immediately after each intervention session.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maximiliane Uhlich
Lead sponsor
University of Basel
Sponsor institution
Source ClinicalTrials.gov
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