EndometriosisNCT07854925
Protective Factors for Well-being in Endometriosis Patients
A study testing EMPOWER in people with Endometriosis, run by Maximiliane Uhlich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- EMPOWER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- self-diagnosed endometriosis
- asymptomatic endometriosis
- single individuals
- only one partner willing to participate
- no access to a mobile device
- pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Simone Wyss, MSc contact
About this study
Official title: Resilience Through Connection: Protective Factors for Well-bein in Endometriosis Patients
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
- Being tested
- EMPOWER, Control
- Keywords
- Endometriosis, Women's health, Mindfulness, Partner Support, Well-being
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWERBehavioural
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).
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Behavioral: Control |
| EMPOWER-Intervention | Experimental | Not described Receives: Behavioral: EMPOWER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Five-point Likert scale ("0 = Not at all true" - "4 = Completely true"); higher scores indicate higher levels of life satisfaction.
Measured: Baseline; one month post-intervention; seven months post-intervention.
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.
Measured: Baseline; one month post-intervention; seven months post-intervention.
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.
Measured: Baseline; one month post-intervention; seven months post-intervention.
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.
Measured: Baseline; one month post-intervention; seven months post-intervention.
Endometriosis Pain and Bleeding Diary (Deal et al., 2010)
11-point Likert scale ("0 = No pain" - "10 = Strongest imaginable pain"; phrasing varies by item) and 6-point Likert scale ("0 = Never" - "5 = Always"; phrasing varies by item); higher scores indicate higher pain/bleeding severity.
Measured: Baseline; one month post-intervention; seven months post-intervention.
Positive and Negative Affect Schedule (PANAS; Thompson, 2007; Watson et al., 1988)
Five-point Likert scale ("0 = Not at all true" - "4 = Completely true"); higher scores indicate higher positive or negative affect.
Measured: Baseline; immediately before and after each intervention session.
Generalized Anxiety Disorder Screener (GAD-7 / GAD-2; Kroenke et al., 2007)
Four-point Likert scale ("0 = Very rarely" - "3 = Often"); higher scores indicate higher levels of anxiety symptoms.
Measured: Baseline (GAD-7); one month post-intervention (GAD-2); seven months post-intervention (GAD-2).
Patient Health Questionnaire (PHQ-9 / PHQ-2; Kroenke et al., 2001)
Four-point Likert scale ("0 = Very rarely" - "3 = Often"); higher scores indicate higher levels of depressive symptoms.
Measured: Baseline (PHQ-9); one month post-intervention (PHQ-2); seven months post-intervention (PHQ-2).
We-Disease Questionnaire (WDQ; Vogt et al., 2024)
Four-point Likert scale ("0 = Not applicable at all" - "3 = Very applicable"); higher scores indicate stronger perception of illness as a shared dyadic challenge.
Measured: Baseline; one month post-intervention; seven months post-intervention.
Female Sexual Function Index Short Form (FSFI-SF; Rosen et al., 2000)
Five- to six-point Likert scale (0-4/5; phrasing varies by item); higher scores indicate better sexual function and higher satisfaction.
Measured: Baseline; one month post-intervention; seven months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maximiliane Uhlich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maximiliane Uhlich, University of Basel
- Investigators
- Maximiliane Uhlich, PhD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854925
- Sponsor's protocol ID
- 2026-00695
- Other IDs
- PZ00-1_233235
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, anonymized data will be made publicly available via appropriate science platforms (e.g., OSF). Demographic information will only be published in aggregated form and will be removed before posting data on open science repositories. Participants are informed about this in the consent form.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Through Connection: Protective Factors for Well-bein in Endometriosis Patients
- ClinicalTrials.gov ID
- NCT07854925
- Acronym / sponsor ID
- 2026-00695
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Women's health, Mindfulness, Partner Support, Well-being
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Maximiliane UhlichUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control |
| EMPOWER-Intervention | Experimental | Behavioral: EMPOWER |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinically confirmed endometriosis diagnosis
- subjective impact on well-being
- currently in a relationship
- both partners willing to participate
- fluency in German
Key exclusion criteria (6 listed)
- self-diagnosed endometriosis
- asymptomatic endometriosis
- single individuals
- only one partner willing to participate
- no access to a mobile device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWERThe 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). | Behavioural | EMPOWER-Intervention |
| ControlThe 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. | Behavioural | Control |
Primary outcome
WHO-5 Well-Being Index (World Health Organization, 1998)
Time frame: Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.
Six-point Likert scale ("0 = Never" - "5 = All the time"); higher scores indicate higher levels of well-being.
Diurnal Salivary Cortisol Slope (nmol/L; Psychobiological Stress Regulation)
Time frame: On two consecutive days pre-intervention; on the six intervention days, four samples per day.
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.
Current pain Intensity (Numeric Rating Scale)
Time frame: Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.
11-point Likert scale ("0 = No Pain" - "10 = Strongest imaginable pain" ); higher scores indicate higher levels of pain.
Relationship Assessment Scale (RAS; Hendrick, 1988)
Time frame: Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.
Five-point Likert scale ("0 = Very dissatisfied" - "4 = Very satisfied"; phrasing varies by item); higher scores indicate higher relationship satisfaction.
10 secondary outcomes
Satisfaction with Life Scale (SWLS; Diener et al., 1985)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2008)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Practical and Emotional Support Provision and Receipt (Shrout et al., 2006)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Endometriosis Health Profile-30 (EHP-30; Jones et al., 2001)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Endometriosis Pain and Bleeding Diary (Deal et al., 2010)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Positive and Negative Affect Schedule (PANAS; Thompson, 2007; Watson et al., 1988)
Time frame: Baseline; immediately before and after each intervention session.
Generalized Anxiety Disorder Screener (GAD-7 / GAD-2; Kroenke et al., 2007)
Time frame: Baseline (GAD-7); one month post-intervention (GAD-2); seven months post-intervention (GAD-2).
Patient Health Questionnaire (PHQ-9 / PHQ-2; Kroenke et al., 2001)
Time frame: Baseline (PHQ-9); one month post-intervention (PHQ-2); seven months post-intervention (PHQ-2).
We-Disease Questionnaire (WDQ; Vogt et al., 2024)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Female Sexual Function Index Short Form (FSFI-SF; Rosen et al., 2000)
Time frame: Baseline; one month post-intervention; seven months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. After the study is completed, anonymized data will be made publicly available via appropriate science platforms (e.g., OSF). Demographic information will only be published in aggregated form and will be removed before posting data on open science repositories. Participants are informed about this in the consent form.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone Wyss, MSc contact
Maximiliane Uhlich, PhD principal investigator
University of Basel
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER in people with Endometriosis, run by Maximiliane Uhlich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maximiliane Uhlich, PhD (+41 61 207 82 85, maximiliane.uhlich@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO-5 Well-Being Index (World Health Organization, 1998) (time frame: Baseline; immediately before and after each intervention session; one month post-intervention; seven months post-intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.