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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.
Six socio-aesthetic therapy workshops (2 hours each) every two weeks over 3 months, focusing on body image, sensory experience, and emotional expression.
Combined individual and group psychotherapy including alternating sessions and final integrative sessions matching the number and duration of individual and group interventions.
Hôpital Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, France
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.
Time frame: Baseline (T1) and 5 months (T2)
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.
Time frame: Baseline and 5 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 5 months
Qualitative Themes Emerging From Semi-Structured Interviews
Qualitative analysis of thematic content from baseline and final interviews.
Time frame: Baseline and 5 months
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