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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02054-45 | Other Identifier | ID RCB |
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| Name | Class |
|---|---|
| Université Lyon 2 | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL Group - No Psychological Intervention | No Intervention | Participants receive no structured psychological intervention during the 5-month study period. Usual medical care continues without modification. | |
| INDIVIDUAL PSYCHOTHERAPY - Individual Psychotherapy (PI) | Other | 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. |
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| SOCIO-AESTHETIC GROUP THERAPY - Socio-Aesthetic Group Therapy (PG) | Other | 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. |
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| MIXED PSYCHOTHERAPY - Mixed Individual + Group Psychotherapy (PGI) | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual Psychotherapy | Behavioral | Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Endometriosis-Related Quality of Life (EHP-30 score) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Symptoms (HADS-A score) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lecointe Mariane | Contact | 04 78 86 66 53 | +33 | mariane.lecointe@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lyon Sud - Hospices Civils de Lyon | Pierre-Bénite | 69310 | France |
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.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Four-arm parallel randomized study evaluating three psychological interventions versus control.
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| 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. |
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| 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. |
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| Change in Depression Symptoms (HADS-D score) | 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) | 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) | 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 |
| Qualitative Themes Emerging From Semi-Structured Interviews | Qualitative analysis of thematic content from baseline and final interviews. | Baseline and 5 months |
| D000091662 | Genital Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D012919 | Social Behavior |