Psychological Support Interventions and Their Effect on Quality of Life and Psychological Functioning in Women With Endometriosis: A Randomized Controlled Trial (ENDOPSY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Endometriosis-Related Quality of Life (EHP-30 score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women ≥18 years
- •Clinical diagnosis of endometriosis
- •Ability to understand and complete psychological evaluations
- •Signed written informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Socio-Aesthetic Group Therapy (Behavioral)
结局指标
主要结局
Change in Endometriosis-Related Quality of Life (EHP-30 score)
时间窗: 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.
次要结局
- 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)