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NCT Number: NCT07280052

Psychological Support Interventions for Women With Endometriosis (ENDOPSY)

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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Key information

Conditions

Endometriosis Anxiety Disorders Behavior Behavioral Symptoms Depression Emotional Regulation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Self-Control Social Behavior Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, 69310, France

Location contact

François GOLFIER, Pr

SUB_INVESTIGATOR

Mariane Lecointe

CONTACT

[email protected]

04 78 86 66 53 ext. +33

Pierre-Adrien BOLZE, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individual Psychotherapy

Behavioral

Ten individual psychotherapy sessions (45 minutes each) delivered every two weeks for 5 months by trained psychologists.

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.

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.

Primary outcomes

  1. 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

  1. Change in Anxiety Symptoms (HADS-A score)

    Time frame: 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.

  2. Change in Depression Symptoms (HADS-D score)

    Time frame: 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.

  3. Change in Alexithymia (TAS-20 score)

    Time frame: 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.

  4. Change in Emotion Regulation (ERQ scores)

    Time frame: 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.

  5. Qualitative Themes Emerging From Semi-Structured Interviews

    Time frame: Baseline and 5 months

    Qualitative analysis of thematic content from baseline and final interviews.

Study contacts

Contact information is provided by the study sponsor or research team.

Lecointe Mariane

CONTACT

[email protected]

04 78 86 66 53 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Université Lyon 2

Registry information

Official study title

Psychological Support Interventions and Their Effect on Quality of Life and Psychological Functioning in Women With Endometriosis: A Randomized Controlled Trial (ENDOPSY)

Acronym: ENDOPSY

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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