EndometriosisT-ENDONCT07907848
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
A study testing Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) in people with Endometriosis and Adenomyosis, run by Fiammetta Cosci at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Adenomyosis
- What is being tested?
- Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2027to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- Under stable pharmacological treatment for at least 3 months;
- For Study 1: ≤12 months from diagnosis;
- For Study 2: >12 months from diagnosis.
Who cannot join
- Current psychiatric diagnosis assessed with the Structured Clinical Interview for DSM-5 (SCID-5; First et al., 2016);
- Ongoing psychotherapeutic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Endometriosis Center, Department of Obstetrics and Gynecology, Careggi University Hospital (AOUC)
Florence, FI, 50134
Silvia Vannuccini, 055 794 7150, silvia.vannuccini@unifi.it
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Endometriosis, Adenomyosis
- Being tested
- Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT)
- Keywords
- Endometriosis, Adenomyosis, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Health-Related Quality of Life, Psychotherapeutic Intervention
- Medical subject headings
- Endometriosis, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
| Acceptance and Commitment Therapy (ACT) | Active comparator | 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. Receives: Behavioral: Acceptance and Commitment Therapy (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: change from baseline to 6-month follow up
Secondary outcomes (25)
Endometriosis Health Profile Questionnaire (EHP-5)
Endometriosis Health Profile Questionnaire (EHP-5), with higher scores indicating worse endometriosis-related quality of life.
Measured: 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.
Measured: change from baseline to 6-month follow up
Psychological Pain Index (PPI)
Psychological Pain Index (PPI), with higher scores indicating greater psychological pain.
Measured: change from baseline to 6-month follow up
Symptom Questionnaire (SQ)
Symptom Questionnaire (SQ), with higher scores indicating greater psychological distress.
Measured: 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.
Measured: change from baseline to 6-month follow up
Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale (PCS), with higher scores indicating greater pain catastrophizing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline to 6-month follow up
Cognitive Fusion Questionnaire (CFQ)
Cognitive Fusion Questionnaire (CFQ), with higher scores indicating greater cognitive fusion.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline to 6-month follow up
Chalder Fatigue Scale (CFS)
Chalder Fatigue Scale (CFS), with higher scores indicating greater fatigue.
Measured: change from baseline to 6-month follow up
Fatigue Severity Scale (FSS)
Fatigue Severity Scale (FSS), with higher scores indicating greater fatigue severity.
Measured: change from baseline to 6-month follow up
Beck Hopelessness Scale (BHS)
Beck Hopelessness Scale (BHS), with higher scores indicating greater hopelessness.
Measured: 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.
Measured: 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.
Measured: change from baseline to 6-month follow up
Somatosensory Amplification Scale (SSAS)
Somatosensory Amplification Scale (SSAS), with higher scores indicating greater somatic amplification.
Measured: change from baseline to 6-month follow up
Eating Disorder Inventory (EDI)
Eating Disorder Inventory (EDI), with higher scores indicating greater eating-related psychopathology.
Measured: 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.
Measured: 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.
Measured: change from baseline to 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized (1:1) controlled trial comparing CBT-based versus ACT-based psychotherapeutic interventions in women with endometriosis and/or adenomyosis. During the screening phase, eligibility will be assessed based on the study's inclusion and exclusion criteria. At baseline, sociodemographic and clinical variables (including age, marital status, education, employment status, anthropometric data, reproductive history, endometriosis/adenomyosis characteristics, symptom history, previous treatments, and pain-related clinical features), as well as psychological status, will be assessed. Participants will then be randomly assigned to either the CBT-based or ACT-based intervention. Assessments will be repeated after Session 4 (mid-intervention assessment), after Session 8 (post-intervention assessment), and at the 3- and 6-month follow-ups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fiammetta Cosci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fiammetta Cosci, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907848
- Sponsor's protocol ID
- T-ENDO
- Acronym
- T-ENDO
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.
Publications
Geller S, Levy S, Ashkeloni S, Roeh B, Sbiet E, Avitsur R. Predictors of Psychological Distress in Women with Endometriosis: The Role of Multimorbidity, Body Image, and Self-Criticism. Int J Environ Res Public Health. 2021 Mar 26;18(7):3453. doi: 10.3390/ijerph18073453.
PubMed 33810403Donatti L, Malvezzi H, Azevedo BC, Baracat EC, Podgaec S. Cognitive Behavioral Therapy in Endometriosis, Psychological Based Intervention: A Systematic Review. Rev Bras Ginecol Obstet. 2022 Mar;44(3):295-303. doi: 10.1055/s-0042-1742406. Epub 2022 May 16.
PubMed 35576938Evans S, Skvarc D, Esterman A, Mackay MI, O'Shea M, Van Niekerk L, Druitt ML, Tsaltas J, Knowles SR, Parigi E, Stanley K, Harris J, Barber M, Dober M, Dowding C, Mikocka-Walus A. Telehealth cognitive behavioural therapy improves health-related quality of life and pain in endometriosis: the Healing Pelvic Pain Intervention (HaPPI)-a randomized controlled trial. Hum Reprod Open. 2026 Jan 22;2026(1):hoag006. doi: 10.1093/hropen/hoag006. eCollection 2026.
PubMed 41717450Nakao M, Shirotsuki K, Sugaya N. Cognitive-behavioral therapy for management of mental health and stress-related disorders: Recent advances in techniques and technologies. Biopsychosoc Med. 2021 Oct 3;15(1):16. doi: 10.1186/s13030-021-00219-w.
PubMed 34602086Del Pino-Sedeno T, Cabrera-Maroto M, Abrante-Luis A, Gonzalez-Hernandez Y, Ortiz Herrera MC. Effectiveness of psychological interventions in endometriosis: a systematic review with meta-analysis. Front Psychol. 2024 Oct 28;15:1457842. doi: 10.3389/fpsyg.2024.1457842. eCollection 2024.
PubMed 39529727World Health Organization. (2019). International statistical classification of diseases and related health problems (11th ed.). https://icd.who.int/
First, M. B., Williams, J. B. W., Karg, R. S., & Spitzer, R. L. (2016). Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). American Psychiatric Association Publishing.
Alizadeh, P., Kooshki, S., & Tarvirdizadeh, H. (2024). The effectiveness of cognitive-behavioral therapy on pain intensity, childhood trauma, perfectionism, and psychological flexibility in patients with chronic pain. Health Nexus, 2(3), 8-17. https://doi.org/10.61838/kman.hn.2.3.2
Yu L, Scott W, McCracken LM. Change in fatigue in acceptance and commitment therapy-based treatment for chronic pain and its association with enhanced psychological flexibility. Eur J Pain. 2020 Jan;24(1):234-247. doi: 10.1002/ejp.1480. Epub 2019 Oct 13.
PubMed 31487413Sundstrom FTA, Lavefjord A, Buhrman M, McCracken LM. Associations between psychological flexibility and daily functioning in endometriosis-related pain. Scand J Pain. 2023 Oct 23;24(1). doi: 10.1515/sjpain-2022-0157. eCollection 2024 Jan 1.
PubMed 37867345Shih YH, Wang SJ, Fan CT, Lu TF, Chen YF, Sun L, Hsu ST, Tseng JJ, Lu CH. Long-term risk of psychiatric disorders in women with endometriosis: A retrospective cohort study. Compr Psychiatry. 2026 Jan;144:152649. doi: 10.1016/j.comppsych.2025.152649. Epub 2025 Nov 21.
PubMed 41308609Samami E, Shahhosseini Z, Khani S, Elyasi F. Pain-focused psychological interventions in women with endometriosis: A systematic review. Neuropsychopharmacol Rep. 2023 Sep;43(3):310-319. doi: 10.1002/npr2.12348. Epub 2023 Jun 27.
PubMed 37366616Rostvall M, Magnusson C, Gemzell-Danielsson K, Kosidou K, Sieurin J. Adverse childhood experiences and the risk of endometriosis-a nationwide cohort study. Hum Reprod. 2025 Sep 1;40(9):1735-1743. doi: 10.1093/humrep/deaf101.
PubMed 40495636Ramin-Wright A, Schwartz ASK, Geraedts K, Rauchfuss M, Wolfler MM, Haeberlin F, von Orelli S, Eberhard M, Imthurn B, Imesch P, Fink D, Leeners B. Fatigue - a symptom in endometriosis. Hum Reprod. 2018 Aug 1;33(8):1459-1465. doi: 10.1093/humrep/dey115.
PubMed 29947766Pontoppidan K, Olovsson M, Grundstrom H. Clinical factors associated with quality of life among women with endometriosis: a cross-sectional study. BMC Womens Health. 2023 Oct 24;23(1):551. doi: 10.1186/s12905-023-02694-5.
PubMed 37875883
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Efficacy of Psychotherapeutic Interventions in Patients With ENDOmetriosis: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy vs Acceptance and Commitment Therapy
- ClinicalTrials.gov ID
- NCT07907848
- Acronym / sponsor ID
- T-ENDO / T-ENDO
- Conditions
- Endometriosis, Adenomyosis
- Keywords
- Endometriosis, Adenomyosis, Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Health-Related Quality of Life, Psychotherapeutic Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fiammetta CosciUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized (1:1) controlled trial comparing CBT-based versus ACT-based psychotherapeutic interventions in women with endometriosis and/or adenomyosis. During the screening phase, eligibility will be assessed based on the study's inclusion and exclusion criteria. At baseline, sociodemographic and clinical variables (including age, marital status, education, employment status, anthropometric data, reproductive history, endometriosis/adenomyosis characteristics, symptom history, previous treatments, and pain-related clinical features), as well as psychological status, will be assessed. Participants will then be randomly assigned to either the CBT-based or ACT-based intervention. Assessments will be repeated after Session 4 (mid-intervention assessment), after Session 8 (post-intervention assessment), and at the 3- and 6-month follow-ups.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: 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. |
| Acceptance and Commitment Therapy (ACT) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (2 listed)
- Current psychiatric diagnosis assessed with the Structured Clinical Interview for DSM-5 (SCID-5; First et al., 2016);
- Ongoing psychotherapeutic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)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. | Behavioural | Cognitive Behavioral Therapy (CBT) |
| Acceptance and Commitment Therapy (ACT)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. | Behavioural | Acceptance and Commitment Therapy (ACT) |
Primary outcome
EQ-5D-5L
Time frame: 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).
25 secondary outcomes
Endometriosis Health Profile Questionnaire (EHP-5)
Time frame: change from baseline to 6-month follow up
Brief Pain Inventory - Short Form (BPI-SF)
Time frame: change from baseline to 6-month follow up
Psychological Pain Index (PPI)
Time frame: change from baseline to 6-month follow up
Symptom Questionnaire (SQ)
Time frame: change from baseline to 6-month follow up
Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Time frame: change from baseline to 6-month follow up
Pain Catastrophizing Scale (PCS)
Time frame: change from baseline to 6-month follow up
Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: change from baseline to 6-month follow up
Multidimensional Psychological Flexibility Inventory (MPFI)
Time frame: change from baseline to 6-month follow up
Acceptance and Action Questionnaire - II (AAQ-II)
Time frame: change from baseline to 6-month follow up
Cognitive Fusion Questionnaire (CFQ)
Time frame: change from baseline to 6-month follow up
Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: change from baseline to 6-month follow up
Satisfaction with Life Scale (SWLS)
Time frame: change from baseline to 6-month follow up
World Health Organization-Five Well-Being Index (WHO-5)
Time frame: change from baseline to 6-month follow up
Illness Attitudes Scale (IAS)
Time frame: change from baseline to 6-month follow up
Brief Illness Perception Questionnaire (BIPQ)
Time frame: change from baseline to 6-month follow up
Female Sexual Function Index (FSFI)
Time frame: change from baseline to 6-month follow up
Chalder Fatigue Scale (CFS)
Time frame: change from baseline to 6-month follow up
Fatigue Severity Scale (FSS)
Time frame: change from baseline to 6-month follow up
Beck Hopelessness Scale (BHS)
Time frame: change from baseline to 6-month follow up
Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI)
Time frame: change from baseline to 6-month follow up
Frost Multidimensional Perfectionism Scale (FMPS)
Time frame: change from baseline to 6-month follow up
Somatosensory Amplification Scale (SSAS)
Time frame: change from baseline to 6-month follow up
Eating Disorder Inventory (EDI)
Time frame: change from baseline to 6-month follow up
Childhood Trauma Questionnaire - Short Form (CTQ-SF)
Time frame: change from baseline to 6-month follow up
Social Readjustment Rating Scale (SRRS)
Time frame: change from baseline to 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Results publication: PubMed 33810403Geller S, Levy S, Ashkeloni S, Roeh B, Sbiet E, Avitsur R. Predictors of Psychological Distress in Women with Endometriosis: The Role of Multimorbidity, Body Image, and Self-Criticism. Int J Environ Res Public Health. 2021 Mar 26;18(7):3453. doi: 10.3390/ijerph18073453.
- Results publication: PubMed 35576938Donatti L, Malvezzi H, Azevedo BC, Baracat EC, Podgaec S. Cognitive Behavioral Therapy in Endometriosis, Psychological Based Intervention: A Systematic Review. Rev Bras Ginecol Obstet. 2022 Mar;44(3):295-303. doi: 10.1055/s-0042-1742406. Epub 2022 May 16.
- Results publication: PubMed 41717450Evans S, Skvarc D, Esterman A, Mackay MI, O'Shea M, Van Niekerk L, Druitt ML, Tsaltas J, Knowles SR, Parigi E, Stanley K, Harris J, Barber M, Dober M, Dowding C, Mikocka-Walus A. Telehealth cognitive behavioural therapy improves health-related quality of life and pain in endometriosis: the Healing Pelvic Pain Intervention (HaPPI)-a randomized controlled trial. Hum Reprod Open. 2026 Jan 22;2026(1):hoag006. doi: 10.1093/hropen/hoag006. eCollection 2026.
- Results publication: PubMed 34602086Nakao M, Shirotsuki K, Sugaya N. Cognitive-behavioral therapy for management of mental health and stress-related disorders: Recent advances in techniques and technologies. Biopsychosoc Med. 2021 Oct 3;15(1):16. doi: 10.1186/s13030-021-00219-w.
- Results publication: PubMed 39529727Del Pino-Sedeno T, Cabrera-Maroto M, Abrante-Luis A, Gonzalez-Hernandez Y, Ortiz Herrera MC. Effectiveness of psychological interventions in endometriosis: a systematic review with meta-analysis. Front Psychol. 2024 Oct 28;15:1457842. doi: 10.3389/fpsyg.2024.1457842. eCollection 2024.
- Results publicationWorld Health Organization. (2019). International statistical classification of diseases and related health problems (11th ed.). https://icd.who.int/
- Results publicationFirst, M. B., Williams, J. B. W., Karg, R. S., & Spitzer, R. L. (2016). Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). American Psychiatric Association Publishing.
- Results publicationAlizadeh, P., Kooshki, S., & Tarvirdizadeh, H. (2024). The effectiveness of cognitive-behavioral therapy on pain intensity, childhood trauma, perfectionism, and psychological flexibility in patients with chronic pain. Health Nexus, 2(3), 8-17. https://doi.org/10.61838/kman.hn.2.3.2
- Results publication: PubMed 31487413Yu L, Scott W, McCracken LM. Change in fatigue in acceptance and commitment therapy-based treatment for chronic pain and its association with enhanced psychological flexibility. Eur J Pain. 2020 Jan;24(1):234-247. doi: 10.1002/ejp.1480. Epub 2019 Oct 13.
- Results publication: PubMed 37867345Sundstrom FTA, Lavefjord A, Buhrman M, McCracken LM. Associations between psychological flexibility and daily functioning in endometriosis-related pain. Scand J Pain. 2023 Oct 23;24(1). doi: 10.1515/sjpain-2022-0157. eCollection 2024 Jan 1.
- Results publication: PubMed 41308609Shih YH, Wang SJ, Fan CT, Lu TF, Chen YF, Sun L, Hsu ST, Tseng JJ, Lu CH. Long-term risk of psychiatric disorders in women with endometriosis: A retrospective cohort study. Compr Psychiatry. 2026 Jan;144:152649. doi: 10.1016/j.comppsych.2025.152649. Epub 2025 Nov 21.
- Results publication: PubMed 37366616Samami E, Shahhosseini Z, Khani S, Elyasi F. Pain-focused psychological interventions in women with endometriosis: A systematic review. Neuropsychopharmacol Rep. 2023 Sep;43(3):310-319. doi: 10.1002/npr2.12348. Epub 2023 Jun 27.
- Individual participant dataSharing planned: Yes. Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) in people with Endometriosis and Adenomyosis, run by Fiammetta Cosci at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiammetta Cosci (0552755066, fiammetta.cosci@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L (time frame: change from baseline to 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07907848, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.