NCT07907848Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Testing Efficacy of Psychotherapeutic Interventions in Patients With ENDOmetriosis: A Randomized Controlled Trial Comparing Cognitive Behavioral Therapy vs Acceptance and Commitment Therapy
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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. It will include women with a recent diagnosis and women who have been living with the diagnosis for a longer time. The main questions are: * Do CBT and ACT differ in their effects on health-related quality of life? * Do the two therapies differ in their effects on pain-related difficulties, emotional well-being, fatigue, sexual functioning, and other aspects of daily life? 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 24 Oct 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Fiammetta Cosci
- Diseases
- Endometriosis
- NCT number
- NCT07907848
What you commit to
- Study type: Interventional
- Planned participants: 128
- From 1 Jan 2027 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current psychiatric diagnosis assessed with the Structured Clinical Interview for DSM-5 (SCID-5; First et al., 2016);
Other
- Ongoing psychotherapeutic treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Endometriosis Center, Department of Obstetrics and Gynecology, Careggi University Hospital (AOUC) Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.