Psychological Support Interventions and Their Effect on Quality of Life and Psychological Functioning in Women With Endometriosis: A Randomized Controlled Trial (ENDOPSY)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Endometriosis-Related Quality of Life (EHP-30 score)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CONTROL Group - No Psychological Intervention
Participants receive no structured psychological intervention during the 5-month study period. Usual medical care continues without modification.
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.
Intervention: Individual Psychotherapy (Behavioral)
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.
Intervention: Mixed Psychotherapy (Behavioral)
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.
Intervention: Socio-Aesthetic Group Therapy (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Emotion Regulation (ERQ scores)(Baseline and 5 months)
- 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)
- Qualitative Themes Emerging From Semi-Structured Interviews(Baseline and 5 months)