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Not yet recruiting NCT07280052

Psychological Support Interventions for Women With Endometriosis (ENDOPSY)

No phase Interventional Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individual Psychotherapy, Socio-Aesthetic Group Therapy, Mixed Psychotherapy.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Psychological Support Interventions and Their Effect on Quality of Life and Psychological Functioning in Women With Endometriosis: A Randomized Controlled Trial (ENDOPSY)

Overview

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.

Interventions

  • Behavioral Individual Psychotherapy
    Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
  • 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.
  • 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.

Primary outcome measures

  • Change in Endometriosis-Related Quality of Life (EHP-30 score) [Time frame: Baseline (T1) and 5 months (T2)]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Hôpital Lyon Sud - Hospices Civils de Lyon — Pierre-Bénite

Identifiers

NCT: NCT07280052 · 69HCL25_0655 · 2025-A02054-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗