An interventional study of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) in Endometriosis and Adenomyosis, sponsored by Fiammetta Cosci. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Fiammetta Cosci · Not applicable, Interventional, and Treatment
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.
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.
929 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
This study's planned enrollment of 128 is above the median of 66 across 541 interventional studies indexed under Endometriosis.
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Exclusion Criteria:
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.
Behavioral: Cognitive Behavioral Therapy (CBT)
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.
Behavioral: Acceptance and Commitment Therapy (ACT)
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.
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.
EQ-5D-5L
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).
Time frame: change from baseline to 6-month follow up
Endometriosis Health Profile Questionnaire (EHP-5)
Endometriosis Health Profile Questionnaire (EHP-5), with higher scores indicating worse endometriosis-related quality of life.
Time frame: change from baseline to 6-month follow up
Brief Pain Inventory - Short Form (BPI-SF)
Brief Pain Inventory - Short Form (BPI-SF), with higher scores indicating greater pain-related disability.
Time frame: change from baseline to 6-month follow up
Psychological Pain Index (PPI)
Psychological Pain Index (PPI), with higher scores indicating greater psychological pain.
Time frame: change from baseline to 6-month follow up
Symptom Questionnaire (SQ)
Symptom Questionnaire (SQ), with higher scores indicating greater psychological distress.
Time frame: change from baseline to 6-month follow up
Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Somatic Symptom Disorder - B Criteria Scale (SSD-12), with higher scores indicating greater somatic symptom burden.
Time frame: change from baseline to 6-month follow up
Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale (PCS), with higher scores indicating greater pain catastrophizing.
Time frame: change from baseline to 6-month follow up
Chronic Pain Acceptance Questionnaire (CPAQ)
Chronic Pain Acceptance Questionnaire (CPAQ), with higher scores indicating greater pain acceptance.
Time frame: change from baseline to 6-month follow up
Multidimensional Psychological Flexibility Inventory (MPFI)
Multidimensional Psychological Flexibility Inventory (MPFI), with higher scores indicating greater psychological flexibility/inflexibility.
Time frame: change from baseline to 6-month follow up
Acceptance and Action Questionnaire - II (AAQ-II)
Acceptance and Action Questionnaire - II (AAQ-II), with higher scores indicating greater psychological inflexibility.
Time frame: change from baseline to 6-month follow up
Cognitive Fusion Questionnaire (CFQ)
Cognitive Fusion Questionnaire (CFQ), with higher scores indicating greater cognitive fusion.
Time frame: change from baseline to 6-month follow up
Cognitive Emotion Regulation Questionnaire (CERQ)
Cognitive Emotion Regulation Questionnaire (CERQ), with higher scores indicating greater use of that specific emotion regulation strategy.
Time frame: change from baseline to 6-month follow up
Satisfaction with Life Scale (SWLS)
Satisfaction with Life Scale (SWLS), with higher scores indicating greater life satisfaction.
Time frame: change from baseline to 6-month follow up
World Health Organization-Five Well-Being Index (WHO-5)
World Health Organization-Five Well-Being Index (WHO-5), with higher scores indicating greater psychological well-being.
Time frame: change from baseline to 6-month follow up
Illness Attitudes Scale (IAS)
Illness Attitudes Scale (IAS), with higher scores indicating more dysfunctional illness-related attitudes.
Time frame: change from baseline to 6-month follow up
Brief Illness Perception Questionnaire (BIPQ)
Brief Illness Perception Questionnaire (BIPQ), with higher scores indicating more negative illness perceptions.
Time frame: change from baseline to 6-month follow up
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI), with higher scores indicating better sexual functioning.
Time frame: change from baseline to 6-month follow up
Chalder Fatigue Scale (CFS)
Chalder Fatigue Scale (CFS), with higher scores indicating greater fatigue.
Time frame: change from baseline to 6-month follow up
Fatigue Severity Scale (FSS)
Fatigue Severity Scale (FSS), with higher scores indicating greater fatigue severity.
Time frame: change from baseline to 6-month follow up
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS), with higher scores indicating greater hopelessness.
Time frame: change from baseline to 6-month follow up
Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI)
Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI), with higher scores indicating greater demoralization.
Time frame: change from baseline to 6-month follow up
Frost Multidimensional Perfectionism Scale (FMPS)
Frost Multidimensional Perfectionism Scale (FMPS), with higher scores indicating higher levels of perfectionism.
Time frame: change from baseline to 6-month follow up
Somatosensory Amplification Scale (SSAS)
Somatosensory Amplification Scale (SSAS), with higher scores indicating greater somatic amplification.
Time frame: change from baseline to 6-month follow up
Eating Disorder Inventory (EDI)
Eating Disorder Inventory (EDI), with higher scores indicating greater eating-related psychopathology.
Time frame: change from baseline to 6-month follow up
Childhood Trauma Questionnaire - Short Form (CTQ-SF)
Childhood Trauma Questionnaire - Short Form (CTQ-SF), with higher scores indicating greater exposure to childhood trauma.
Time frame: change from baseline to 6-month follow up
Social Readjustment Rating Scale (SRRS)
Social Readjustment Rating Scale (SRRS), with higher scores indicating greater exposure to stressful life events.
Time frame: change from baseline to 6-month follow up
Plan to share: Yes — Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.
Supporting information: Informed consent form, Clinical study report
Time frame: From 01.01.2030 to 31.12.2030
Access criteria: Researchers will be able to access.
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