Psychological Support Interventions for Women With Endometriosis (ENDOPSY)

Sponsor
Hospices Civils de Lyon
Study ID
NCT07280052
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Individual Psychotherapy — BEHAVIORAL
    Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
  • Socio-Aesthetic Group Therapy — BEHAVIORAL
    Six socio-aesthetic therapy workshops (2 hours each) every two weeks over 3 months, focusing on body image, sensory experience, and emotional expression.
  • Mixed Psychotherapy — BEHAVIORAL
    Combined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions.

Study Details

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.

Key Dates

First listed
Dec 12, 2025
Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Change in Endometriosis-Related Quality of Life (EHP-30 score) [ Time Frame: Baseline (T1) and 5 months (T2) ]

Central Contacts

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