EndometriosisENDOPSYNCT07280052
Psychological Support Interventions for Women With Endometriosis (ENDOPSY)
A study testing Individual Psychotherapy, Socio-Aesthetic Group Therapy and Mixed Psychotherapy in people with Endometriosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Endometriosis is associated with severe pain, impaired quality of life and significant psychological distress. Psychological support may help improve emotional regulation, mental health, and quality of life in affected women. 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?
- Individual Psychotherapy, Socio-Aesthetic Group Therapy and Mixed Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Jun 2027
- 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
- Adult women ≥18 years
- Clinical diagnosis of endometriosis
- Ability to understand and complete psychological evaluations
- Signed written informed consent
Who cannot join
- Ongoing psychotherapy
- Cognitive, sensory or language impairments preventing participation
- Participation in another interventional clinical study
- Persons under legal protection
- Non-French speakers
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, 69310
Mariane Lecointe, 04 78 86 66 53 ext. +33, mariane.lecointe@chu-lyon.fr
François GOLFIER, Pr
About this study
Official title: Psychological Support Interventions and Their Effect on Quality of Life and Psychological Functioning in Women With Endometriosis: A Randomized Controlled Trial (ENDOPSY)
Endometriosis is associated with severe pain, impaired quality of life and significant psychological distress. Psychological support may help improve emotional regulation, mental health, and quality of life in affected women. This randomized controlled trial evaluates the impact of three psychological support interventions-individual psychotherapy, socio-aesthetic group therapy, and a mixed approach combining both-on psychological symptoms and quality of life. Forty participants will be randomized into four parallel arms. The study hypothesis is that psychological support interventions improve psychological functioning and disease-related quality of life compared with no intervention, and that the combined mixed approach may produce greater benefits than the individual or group interventions alone.
- Conditions
- Endometriosis
- Being tested
- Individual Psychotherapy, Socio-Aesthetic Group Therapy, Mixed Psychotherapy
- Keywords
- Endometriosis, Psychological Support, Psychotherapy, Quality of Life, Anxiety, Depression, Emotional Regulation, Women's Health
- Medical subject headings
- Endometriosis, Anxiety Disorders, Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual PsychotherapyBehavioural
Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
Socio-Aesthetic Group TherapyBehavioural
Six socio-aesthetic therapy workshops (2 hours each) every two weeks over 3 months, focusing on body image, sensory experience, and emotional expression.
Mixed PsychotherapyBehavioural
Combined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL Group - No Psychological Intervention | No intervention | Participants receive no structured psychological intervention during the 5-month study period. Usual medical care continues without modification. |
| INDIVIDUAL PSYCHOTHERAPY - Individual Psychotherapy (PI) | Other | Individual psychotherapy sessions conducted by trained clinical psychologists. Ten sessions lasting 45 minutes each are delivered every two weeks over a 5-month period. The intervention focuses on emotional experience, psychological support, and associative processes related to endometriosis. Receives: Behavioral: Individual Psychotherapy |
| SOCIO-AESTHETIC GROUP THERAPY - Socio-Aesthetic Group Therapy (PG) | Other | Six socio-aesthetic group therapy workshops delivered every two weeks over approximately three months. Sessions last 2 hours each and include skincare, sensory exploration, self-image work, and shared emotional expression. Co-conducted by a socio-esthetician and a psychologist. Receives: Behavioral: Mixed Psychotherapy |
| MIXED PSYCHOTHERAPY - Mixed Individual + Group Psychotherapy (PGI) | Other | Combined intervention including two initial individual sessions, alternating individual and group therapy thereafter, and three closing individual sessions. Duration and number of sessions match the individual and group-only interventions. Receives: Behavioral: Socio-Aesthetic Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endometriosis-Related Quality of Life (EHP-30 score)
Change in the EHP-30 total score between baseline and post-intervention. Higher scores indicate worse quality of life.
Measured: Baseline (T1) and 5 months (T2)
Secondary outcomes (5)
Change in Anxiety Symptoms (HADS-A score)
Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) between baseline and T2.
The HADS-A consists of 7 items scored from 0 to 3, with a total score ranging from 0 to 21.
Higher scores indicate more severe anxiety symptoms.
Measured: Baseline and 5 months
Change in Depression Symptoms (HADS-D score)
Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) between baseline and T2.
The HADS-D consists of 7 items scored from 0 to 3, with a total score ranging from 0 to 21.
Higher scores indicate more severe depressive symptoms.
Measured: Baseline and 5 months
Change in Alexithymia (TAS-20 score)
Change in alexithymia measured by the Toronto Alexithymia Scale - 20 items (TAS-20) between baseline and T2.
The TAS-20 consists of 20 items scored from 1 to 5, with a total score ranging from 20 to 100.
Higher scores indicate higher levels of alexithymia.
Measured: Baseline and 5 months
Change in Emotion Regulation (ERQ scores)
Change in emotion regulation measured by the Emotion Regulation Questionnaire (ERQ) cognitive reappraisal and expressive suppression subscales between baseline and T2.
The ERQ includes two subscales:
Cognitive Reappraisal (6 items; score range 6 to 42)
Expressive Suppression (4 items; score range 4 to 28)
Items are scored on a 7-point Likert scale. Higher scores indicate greater use of the corresponding emotion regulation strategy.
Measured: Baseline and 5 months
Qualitative Themes Emerging From Semi-Structured Interviews
Qualitative analysis of thematic content from baseline and final interviews.
Measured: Baseline and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm parallel randomized study evaluating three psychological interventions versus control.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Université Lyon 2
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280052
- Sponsor's protocol ID
- 69HCL25_0655
- Other IDs
- 2025-A02054-45
- Acronym
- ENDOPSY
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be made publicly available or shared with external researchers. This study collects sensitive psychological and health-related data in a small, single-center cohort. Even after de-identification/pseudonymization, the risk of re-identification cannot be sufficiently minimized. Study results may be shared in aggregate form (e.g., summary statistics) in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Support Interventions and Their Effect on Quality of Life and Psychological Functioning in Women With Endometriosis: A Randomized Controlled Trial (ENDOPSY)
- ClinicalTrials.gov ID
- NCT07280052
- Acronym / sponsor ID
- ENDOPSY / 69HCL25_0655
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Psychological Support, Psychotherapy, Quality of Life, Anxiety, Depression, Emotional Regulation, Women's Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Université Lyon 2
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Dec 2025 (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 associated with severe pain, impaired quality of life and significant psychological distress. Psychological support may help improve emotional regulation, mental health, and quality of life in affected women. This randomized controlled trial evaluates the impact of three psychological support interventions-individual psychotherapy, socio-aesthetic group therapy, and a mixed approach combining both-on psychological symptoms and quality of life. Forty participants will be randomized into four parallel arms. The study hypothesis is that psychological support interventions improve psychological functioning and disease-related quality of life compared with no intervention, and that the combined mixed approach may produce greater benefits than the individual or group interventions alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four-arm parallel randomized study evaluating three psychological interventions versus control.
| Arm | Type | Receives |
|---|---|---|
| CONTROL Group - No Psychological Intervention | No intervention | –Participants receive no structured psychological intervention during the 5-month study period. Usual medical care continues without modification. |
| INDIVIDUAL PSYCHOTHERAPY - Individual Psychotherapy (PI) | Other | Behavioral: Individual PsychotherapyIndividual psychotherapy sessions conducted by trained clinical psychologists. Ten sessions lasting 45 minutes each are delivered every two weeks over a 5-month period. The intervention focuses on emotional experience, psychological support, and associative processes related to endometriosis. |
| SOCIO-AESTHETIC GROUP THERAPY - Socio-Aesthetic Group Therapy (PG) | Other | Behavioral: Mixed PsychotherapySix socio-aesthetic group therapy workshops delivered every two weeks over approximately three months. Sessions last 2 hours each and include skincare, sensory exploration, self-image work, and shared emotional expression. Co-conducted by a socio-esthetician and a psychologist. |
| MIXED PSYCHOTHERAPY - Mixed Individual + Group Psychotherapy (PGI) | Other | Behavioral: Socio-Aesthetic Group TherapyCombined intervention including two initial individual sessions, alternating individual and group therapy thereafter, and three closing individual sessions. Duration and number of sessions match the individual and group-only interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult women ≥18 years
- Clinical diagnosis of endometriosis
- Ability to understand and complete psychological evaluations
- Signed written informed consent
Key exclusion criteria (6 listed)
- Ongoing psychotherapy
- Cognitive, sensory or language impairments preventing participation
- Participation in another interventional clinical study
- Persons under legal protection
- Non-French speakers
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 |
|---|---|---|
| Individual PsychotherapyTen individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists. | Behavioural | INDIVIDUAL PSYCHOTHERAPY - Individual Psychotherapy (PI) |
| Socio-Aesthetic Group TherapySix socio-aesthetic therapy workshops (2 hours each) every two weeks over 3 months, focusing on body image, sensory experience, and emotional expression. | Behavioural | MIXED PSYCHOTHERAPY - Mixed Individual + Group Psychotherapy (PGI) |
| Mixed PsychotherapyCombined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions. | Behavioural | SOCIO-AESTHETIC GROUP THERAPY - Socio-Aesthetic Group Therapy (PG) |
Primary outcome
Change in Endometriosis-Related Quality of Life (EHP-30 score)
Time frame: Baseline (T1) and 5 months (T2)
Change in the EHP-30 total score between baseline and post-intervention. Higher scores indicate worse quality of life.
5 secondary outcomes
Change in Anxiety Symptoms (HADS-A score)
Time frame: Baseline and 5 months
Change in Depression Symptoms (HADS-D score)
Time frame: Baseline and 5 months
Change in Alexithymia (TAS-20 score)
Time frame: Baseline and 5 months
Change in Emotion Regulation (ERQ scores)
Time frame: Baseline and 5 months
Qualitative Themes Emerging From Semi-Structured Interviews
Time frame: Baseline and 5 months
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 29 Jan 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be made publicly available or shared with external researchers. This study collects sensitive psychological and health-related data in a small, single-center cohort. Even after de-identification/pseudonymization, the risk of re-identification cannot be sufficiently minimized. Study results may be shared in aggregate form (e.g., summary statistics) in publications and presentations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Psychotherapy, Socio-Aesthetic Group Therapy and Mixed Psychotherapy in people with Endometriosis, run by Hospices Civils de Lyon at 1 site in France.
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 4 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lecointe Mariane (04 78 86 66 53 ext. +33, mariane.lecointe@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endometriosis-Related Quality of Life (EHP-30 score) (time frame: Baseline (T1) and 5 months (T2)). 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 29 Jan 2026.