Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy (T-ENDO)
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Fiammetta Cosci
- 전화번호: 0552755066
- 이메일: fiammetta.cosci@unifi.it
연구 장소
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-
FI
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Florence, FI, 이탈리아, 50134
- Endometriosis Center, Department of Obstetrics and Gynecology, Careggi University Hospital (AOUC)
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연락하다:
- Silvia Vannuccini
- 전화번호: 055 794 7150
- 이메일: silvia.vannuccini@unifi.it
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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EQ-5D-5L
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Endometriosis Health Profile Questionnaire (EHP-5)
기간: 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
|
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Brief Pain Inventory - Short Form (BPI-SF)
기간: 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)
기간: 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
|
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Symptom Questionnaire (SQ)
기간: 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
|
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Somatic Symptom Disorder - B Criteria Scale (SSD-12)
기간: 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)
기간: 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)
기간: 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
|
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Multidimensional Psychological Flexibility Inventory (MPFI)
기간: 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
|
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Acceptance and Action Questionnaire - II (AAQ-II)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
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Female Sexual Function Index (FSFI)
기간: 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)
기간: 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
|
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Fatigue Severity Scale (FSS)
기간: change from baseline to 6-month follow up
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Fatigue Severity Scale (FSS), with higher scores indicating greater fatigue severity. |
change from baseline to 6-month follow up
|
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Beck Hopelessness Scale (BHS)
기간: 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)
기간: 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)
기간: 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)
기간: change from baseline to 6-month follow up
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Somatosensory Amplification Scale (SSAS), with higher scores indicating greater somatic amplification. |
change from baseline to 6-month follow up
|
|
Eating Disorder Inventory (EDI)
기간: 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
|
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Childhood Trauma Questionnaire - Short Form (CTQ-SF)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- Donatti 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.
- Evans 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.
- Nakao 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.
- Del 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.
- World 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.
- Sundstrom 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.
- Shih 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.
- Samami 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.
- Rostvall 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.
- Ramin-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.
- Pontoppidan 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.
- Pilevar S, Teymouri S, Bayazi MH, Rajaei AR. The effectiveness of acceptance and commitment therapy (ACT) on illness perception in orthopedic patients. J Educ Health Promot. 2023 Oct 31;12:342. doi: 10.4103/jehp.jehp_918_22. eCollection 2023.
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- Hansen KE, Brandsborg B, Kesmodel US, Forman A, Kold M, Pristed R, Donchulyesko O, Hartwell D, Vase L. Psychological interventions improve quality of life despite persistent pain in endometriosis: results of a 3-armed randomized controlled trial. Qual Life Res. 2023 Jun;32(6):1727-1744. doi: 10.1007/s11136-023-03346-9. Epub 2023 Feb 17.
- Grinberg, K., Sela, Y., & Nissim, S. (2024). The psychological well-being, catastrophizing, quality of life of among women diagnosed with endometriosis. Women's Health Reports, 5(1), 860-866. https://doi.org/10.1089/whr.2024.0095
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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- T-ENDO
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.
IPD 공유 기간
From 01.01.2030 to 31.12.2030
IPD 공유 액세스 기준
Researchers will be able to access.
IPD 공유 지원 정보 유형
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .