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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy (T-ENDO)

31 de octubre de 2026 actualizado por: Fiammetta Cosci

Testing Efficacy of Psychotherapeutic Interventions in Patients With ENDOmetriosis: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy vs Acceptance and Commitment Therapy

The aim of the present study is to compare two types of psychotherapeutic interventions in women with endometriosis and/or adenomyosis: cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). The study will examine whether these therapies differ in their effects on health-related quality of life. We hypothesis a different effect on health related quality of life pain-related difficulties, emotional well-being, fatigue, sexual functioning, and other aspects of daily life since the two interventions aim at different purposes and results. CBT is based on restructuring of thought, thus the aim and the result are activating a change. ACT is aimed at increasing acceptance of the existing condition in order to cope better with it. The literature indeed suggested that the two approach can produce different effects in the same clinical population.

The study will include women with a recent diagnosis and women who have been living with the diagnosis for a longer time.

Participants will be randomly assigned to receive either CBT or ACT. Both groups will attend eight therapy sessions, held every two weeks. Participants will complete online questionnaires before treatment, after session 4, after treatment, and 3 and 6 months after treatment. The questionnaires will assess quality of life, pain, emotional well-being, and other aspects of health and daily functioning.

The study will take place at the Endometriosis Centre of Careggi University Hospital in Florence, Italy. Eligible participants must be women aged 18 or older who are receiving care at this centre and have a confirmed diagnosis of endometriosis and/or adenomyosis based on medical assessment. They must have been on stable medication treatment for at least 3 months, speak and write Italian fluently, have internet access, and be able to provide informed consent. Women with a current psychiatric diagnosis or who are currently receiving psychotherapy are not eligible to participate in the study.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Endometriosis (ENDO) is a chronic inflammatory disease affecting 4-18% of women with symptoms such as dyspareunia, dysmenorrhea, dyschezia, low back pain, chronic pelvic pain and gastrointestinal manifestations. Meta-analyses showed higher anxiety, depression, and poorer quality of life in women with ENDO compared to healthy controls. Cross-sectional studies suggested that a psychological burden linked to pain and factors such as pain catastrophizing, low pain acceptance, self-criticism, psychological inflexibility (PI), maladaptive coping strategies, sexual dysfunction, maladaptive illness perceptions, early life adversity, negative body image, fatigue and low psychological flexibility. Long-term exposure to ENDO has been associated with an increased risk of developing more severe psychological distress over time. Therefore, accounting for time since diagnosis appears important when examining psychological outcomes in this population.

Psychological interventions such as psychoeducation, mindfulness-based techniques, acceptance and commitment therapy (ACT), and cognitive behavioral therapy (CBT) have shown promising results in improving pain, quality of life, anxiety, and depression in ENDO. However, this literature is sparse, and the methods used are heterogeneous. Furthermore, in these studies only pain, anxiety, depression, and quality of life have been investigated as outcomes measures although evidence from studies on other chronic illnesses and chronic pain conditions suggests that CBT and ACT interventions could also provide benefits in addressing self-criticism, eating-related psychopathology, psychological flexibility, maladaptive coping strategies, sexual dysfunction, maladaptive illness perceptions, fatigue, early life adversity, and negative body image. Furthermore, no studies to date have directly compared ACT-based and CBT-based interventions in women with ENDO. Given their different theoretical models and therapeutic targets, comparing the two interventions may help clarify their potential role in improving psychological adjustment and quality of life in ENDO.

Overall, studying the potential benefits of psychotherapeutic interventions based on CBT versus ACT components using rigorous methods, while accounting for illness duration, may help shed light on complementary therapeutic options for women with ENDO and on ways to modify their psychological burden trajectories, while also extending current knowledge by broadening the range of psychological outcomes assessed beyond commonly studied indicators such as pain, emotional distress, and quality of life.

The aim of the present study is to compare the effects of CBT-based versus ACT-based psychotherapeutic interventions on health-related quality of life in women with endometriosis and/or adenomyosis, considering both women with a recent diagnosis (≤12 months from diagnosis; Study 1) and those with a long-lasting diagnosis (>12 months from diagnosis; Study 2). This operational definition of "long-lasting" conditions is consistent with the literature on chronic illness adaptation, which conceptualizes the first year post-diagnosis as an early adjustment phase, whereas persistence beyond this period reflects a more established chronic illness trajectory and stabilized adaptation processes.

The study will also investigate the effects of the two interventions on a broad range of secondary outcomes in both Study 1 and Study 2, including endometriosis-specific quality of life, pain-related disability, psychological distress, psychological flexibility and related processes, coping strategies and emotion regulation, illness-related attitudes and perceptions, sexual functioning, life satisfaction, psychological well-being, and other clinical and psychological dimensions.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

128

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • FI
      • Florence, FI, Italia, 50134
        • Endometriosis Center, Department of Obstetrics and Gynecology, Careggi University Hospital (AOUC)
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Age ≥ 18 years;
  • Access to internet and having an email address;
  • Diagnosis of endometriosis and/or adenomyosis based on gynecological assessment and imaging evaluation, in accordance with ICD-11 classification (WHO, 2019);
  • Seeking care at the Endometriosis Center (Department of Obstetrics and Gynecology at Careggi University Hospital (AOUC));
  • Ability to provide informed consent;
  • Fluency in written and spoken Italian;
  • Under stable pharmacological treatment for at least 3 months;
  • For Study 1: ≤12 months from diagnosis;
  • For Study 2: >12 months from diagnosis.

Exclusion Criteria:

  • Current psychiatric diagnosis assessed with the Structured Clinical Interview for DSM-5 (SCID-5; First et al., 2016);
  • Ongoing psychotherapeutic treatment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cognitive Behavioral Therapy (CBT)

CBT is a structured intervention targeting dysfunctional thoughts, emotions, and behaviors through psychoeducation, cognitive restructuring, behavioral strategies, and homework. As no standardized CBT protocol for endometriosis exists, this intervention was developed for this study based on CBT principles.

In Study 1, CBT comprises 8 biweekly sessions (4 psychoeducational and 4 CBT sessions) targeting physical pain (including central sensitization), mental pain and distress, relational and functional difficulties (including dyspareunia and fatigue), and maladaptive cognitions (catastrophizing, hopelessness, helplessness, and perfectionism).

In Study 2, CBT comprises 8 biweekly sessions: 4 core sessions addressing physical pain and dysfunctional thinking, mental pain and distress, relational and functional difficulties (including fatigue), and maladaptive cognitions. Each is followed by a consolidation session to review content and reinforce skills through behavioral exercises.

Cognitive behavioral therapy (CBT) delivered over 8 biweekly sessions, including psychoeducation, cognitive restructuring, behavioral strategies, and homework assignments. The intervention addresses physical pain, mental pain and psychological distress, relational and functional difficulties, and maladaptive cognitions. The session structure differs between Study 1 and Study 2.

Comparador activo: Acceptance and Commitment Therapy (ACT)

ACT promotes psychological flexibility and functioning despite distress through psychoeducation, experiential techniques, values-based action, and practice. As no standardized ACT protocol for endometriosis exists, this intervention was developed for this study based on ACT principles.

In Study 1, ACT comprises 8 biweekly sessions (4 psychoeducational, 4 ACT) targeting physical pain (including central sensitization), mental pain and distress, relational and functional difficulties (including dyspareunia and fatigue), and maladaptive cognitions (catastrophizing, hopelessness, helplessness, perfectionism).

In Study 2, ACT comprises 8 biweekly sessions: 4 core sessions address physical pain and an open response style, mental pain and distress, relational and functional difficulties (including fatigue), and maladaptive cognitions. Each is followed by a consolidation session reviewing content and introducing open, centered, and engaged response styles through experiential exercises.

Acceptance and commitment therapy (ACT) delivered over 8 biweekly sessions, including psychoeducation, experiential techniques, values-based action, and behavioral practice. The intervention addresses physical pain, mental pain and psychological distress, relational and functional difficulties, and maladaptive cognitions, while promoting psychological flexibility. The session structure differs between Study 1 and Study 2.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
EQ-5D-5L
Periodo de tiempo: change from baseline to 6-month follow up

The primary outcome will be health-related quality of life, assessed using the EQ-5D-5L (health states range from 11111, representing the best health state, to 55555, representing the worst health state).

change from baseline to 6-month follow up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Endometriosis Health Profile Questionnaire (EHP-5)
Periodo de tiempo: change from baseline to 6-month follow up

Endometriosis Health Profile Questionnaire (EHP-5), with higher scores indicating worse endometriosis-related quality of life.

change from baseline to 6-month follow up
Brief Pain Inventory - Short Form (BPI-SF)
Periodo de tiempo: change from baseline to 6-month follow up

Brief Pain Inventory - Short Form (BPI-SF), with higher scores indicating greater pain-related disability.

change from baseline to 6-month follow up
Psychological Pain Index (PPI)
Periodo de tiempo: change from baseline to 6-month follow up

Psychological Pain Index (PPI), with higher scores indicating greater psychological pain.

change from baseline to 6-month follow up
Symptom Questionnaire (SQ)
Periodo de tiempo: change from baseline to 6-month follow up

Symptom Questionnaire (SQ), with higher scores indicating greater psychological distress.

change from baseline to 6-month follow up
Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Periodo de tiempo: change from baseline to 6-month follow up

Somatic Symptom Disorder - B Criteria Scale (SSD-12), with higher scores indicating greater somatic symptom burden.

change from baseline to 6-month follow up
Pain Catastrophizing Scale (PCS)
Periodo de tiempo: change from baseline to 6-month follow up

Pain Catastrophizing Scale (PCS), with higher scores indicating greater pain catastrophizing.

change from baseline to 6-month follow up
Chronic Pain Acceptance Questionnaire (CPAQ)
Periodo de tiempo: change from baseline to 6-month follow up

Chronic Pain Acceptance Questionnaire (CPAQ), with higher scores indicating greater pain acceptance.

change from baseline to 6-month follow up
Multidimensional Psychological Flexibility Inventory (MPFI)
Periodo de tiempo: change from baseline to 6-month follow up

Multidimensional Psychological Flexibility Inventory (MPFI), with higher scores indicating greater psychological flexibility/inflexibility.

change from baseline to 6-month follow up
Acceptance and Action Questionnaire - II (AAQ-II)
Periodo de tiempo: change from baseline to 6-month follow up

Acceptance and Action Questionnaire - II (AAQ-II), with higher scores indicating greater psychological inflexibility.

change from baseline to 6-month follow up
Cognitive Fusion Questionnaire (CFQ)
Periodo de tiempo: change from baseline to 6-month follow up

Cognitive Fusion Questionnaire (CFQ), with higher scores indicating greater cognitive fusion.

change from baseline to 6-month follow up
Cognitive Emotion Regulation Questionnaire (CERQ)
Periodo de tiempo: change from baseline to 6-month follow up

Cognitive Emotion Regulation Questionnaire (CERQ), with higher scores indicating greater use of that specific emotion regulation strategy.

change from baseline to 6-month follow up
Satisfaction with Life Scale (SWLS)
Periodo de tiempo: change from baseline to 6-month follow up

Satisfaction with Life Scale (SWLS), with higher scores indicating greater life satisfaction.

change from baseline to 6-month follow up
World Health Organization-Five Well-Being Index (WHO-5)
Periodo de tiempo: change from baseline to 6-month follow up

World Health Organization-Five Well-Being Index (WHO-5), with higher scores indicating greater psychological well-being.

change from baseline to 6-month follow up
Illness Attitudes Scale (IAS)
Periodo de tiempo: change from baseline to 6-month follow up

Illness Attitudes Scale (IAS), with higher scores indicating more dysfunctional illness-related attitudes.

change from baseline to 6-month follow up
Brief Illness Perception Questionnaire (BIPQ)
Periodo de tiempo: change from baseline to 6-month follow up

Brief Illness Perception Questionnaire (BIPQ), with higher scores indicating more negative illness perceptions.

change from baseline to 6-month follow up
Female Sexual Function Index (FSFI)
Periodo de tiempo: change from baseline to 6-month follow up

Female Sexual Function Index (FSFI), with higher scores indicating better sexual functioning.

change from baseline to 6-month follow up
Chalder Fatigue Scale (CFS)
Periodo de tiempo: change from baseline to 6-month follow up

Chalder Fatigue Scale (CFS), with higher scores indicating greater fatigue.

change from baseline to 6-month follow up
Fatigue Severity Scale (FSS)
Periodo de tiempo: change from baseline to 6-month follow up

Fatigue Severity Scale (FSS), with higher scores indicating greater fatigue severity.

change from baseline to 6-month follow up
Beck Hopelessness Scale (BHS)
Periodo de tiempo: change from baseline to 6-month follow up

Beck Hopelessness Scale (BHS), with higher scores indicating greater hopelessness.

change from baseline to 6-month follow up
Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI)
Periodo de tiempo: change from baseline to 6-month follow up

Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI), with higher scores indicating greater demoralization.

change from baseline to 6-month follow up
Frost Multidimensional Perfectionism Scale (FMPS)
Periodo de tiempo: change from baseline to 6-month follow up

Frost Multidimensional Perfectionism Scale (FMPS), with higher scores indicating higher levels of perfectionism.

change from baseline to 6-month follow up
Somatosensory Amplification Scale (SSAS)
Periodo de tiempo: change from baseline to 6-month follow up

Somatosensory Amplification Scale (SSAS), with higher scores indicating greater somatic amplification.

change from baseline to 6-month follow up
Eating Disorder Inventory (EDI)
Periodo de tiempo: change from baseline to 6-month follow up

Eating Disorder Inventory (EDI), with higher scores indicating greater eating-related psychopathology.

change from baseline to 6-month follow up
Childhood Trauma Questionnaire - Short Form (CTQ-SF)
Periodo de tiempo: change from baseline to 6-month follow up

Childhood Trauma Questionnaire - Short Form (CTQ-SF), with higher scores indicating greater exposure to childhood trauma.

change from baseline to 6-month follow up
Social Readjustment Rating Scale (SRRS)
Periodo de tiempo: change from baseline to 6-month follow up

Social Readjustment Rating Scale (SRRS), with higher scores indicating greater exposure to stressful life events.

change from baseline to 6-month follow up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

30 de septiembre de 2028

Finalización del estudio (Estimado)

31 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

24 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de octubre de 2026

Publicado por primera vez (Actual)

30 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • T-ENDO

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.

Marco de tiempo para compartir IPD

From 01.01.2030 to 31.12.2030

Criterios de acceso compartido de IPD

Researchers will be able to access.

Tipo de información de apoyo para compartir IPD

  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .