Psychological Support Interventions for Women With Endometriosis (ENDOPSY)
ENDOPSY
2 other identifiers
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
January 29, 2026
January 1, 2026
1.3 years
December 1, 2025
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (T1) and 5 months (T2)
Secondary Outcomes (5)
Change in Anxiety Symptoms (HADS-A score)
Baseline and 5 months
Change in Depression Symptoms (HADS-D score)
Baseline and 5 months
Change in Alexithymia (TAS-20 score)
Baseline and 5 months
Change in Emotion Regulation (ERQ scores)
Baseline and 5 months
Qualitative Themes Emerging From Semi-Structured Interviews
Baseline and 5 months
Study Arms (4)
CONTROL Group - No Psychological Intervention
NO INTERVENTIONParticipants receive no structured psychological intervention during the 5-month study period. Usual medical care continues without modification.
INDIVIDUAL PSYCHOTHERAPY - Individual Psychotherapy (PI)
OTHERIndividual 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)
OTHERSix 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)
OTHERCombined 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.
Interventions
Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
Six socio-aesthetic therapy workshops (2 hours each) every two weeks over 3 months, focusing on body image, sensory experience, and emotional expression.
Combined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions.
Eligibility Criteria
You may qualify if:
- Adult women ≥18 years
- Clinical diagnosis of endometriosis
- Ability to understand and complete psychological evaluations
- Signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospices Civils de Lyonlead
- Université Lyon 2collaborator
Study Sites (1)
Hôpital Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, 69310, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2025
First Posted
December 12, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.