Endometriosis
Conditions
Keywords
Endometriosis, Psychological Support, Psychotherapy, Quality of Life, Anxiety, Depression, Emotional Regulation, Women's Health
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.
Interventions
BEHAVIORALIndividual Psychotherapy
Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
BEHAVIORALSocio-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.
BEHAVIORALMixed Psychotherapy
Combined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions.
Sponsors
Hospices Civils de Lyon
Université Lyon 2
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Four-arm parallel randomized study evaluating three psychological interventions versus control.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endometriosis-Related Quality of Life (EHP-30 score) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms (HADS-A score) | 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. |
| Change in Depression Symptoms (HADS-D score) | 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. |
| Change in Alexithymia (TAS-20 score) | 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. |
| Change in Emotion Regulation (ERQ scores) | 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. |
| Qualitative Themes Emerging From Semi-Structured Interviews | Baseline and 5 months | Qualitative analysis of thematic content from baseline and final interviews. |
Countries
France
Contacts
CONTACTLecointe Mariane
Outcome results
None listed