Psychological Support Interventions for Women With Endometriosis (ENDOPSY) (ENDOPSY)

January 27, 2026 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Hôpital Lyon Sud - Hospices Civils de Lyon
        • Contact:
        • Sub-Investigator:
          • François GOLFIER, Pr
        • Sub-Investigator:
          • Pierre-Adrien BOLZE, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult women ≥18 years
  • Clinical diagnosis of endometriosis
  • Ability to understand and complete psychological evaluations
  • Signed written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL Group - No Psychological Intervention
Participants receive no structured psychological intervention during the 5-month study period. Usual medical care continues without modification.
Other: INDIVIDUAL PSYCHOTHERAPY - Individual Psychotherapy (PI)
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.
Behavioral: Individual Psychotherapy
Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
Other: SOCIO-AESTHETIC GROUP THERAPY - Socio-Aesthetic Group Therapy (PG)
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.
Behavioral: Mixed Psychotherapy
Combined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions.
Other: MIXED PSYCHOTHERAPY - Mixed Individual + Group Psychotherapy (PGI)
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.
Behavioral: Socio-Aesthetic Group Therapy
Six socio-aesthetic therapy workshops (2 hours each) every two weeks over 3 months, focusing on body image, sensory experience, and emotional expression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T1) and 5 months (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Themes Emerging From Semi-Structured Interviews
Time Frame: Baseline and 5 months
Qualitative analysis of thematic content from baseline and final interviews.
Baseline and 5 months
Change in Anxiety Symptoms (HADS-A score)
Time Frame: Baseline and 5 months

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.
Baseline and 5 months
Change in Depression Symptoms (HADS-D score)
Time Frame: Baseline and 5 months

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.
Baseline and 5 months
Change in Alexithymia (TAS-20 score)
Time Frame: Baseline and 5 months

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.
Baseline and 5 months
Change in Emotion Regulation (ERQ scores)
Time Frame: Baseline and 5 months

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.
Baseline and 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Collaborators

Université Lyon 2

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL25_0655
  • 2025-A02054-45 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Individual Psychotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe