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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Fiammetta Cosci
- 電話番号：0552755066
- メール：fiammetta.cosci@unifi.it
研究場所
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FI
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Florence、FI、イタリア、50134
- Endometriosis Center, Department of Obstetrics and Gynecology, Careggi University Hospital (AOUC)
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コンタクト：
- Silvia Vannuccini
- 電話番号：055 794 7150
- メール：silvia.vannuccini@unifi.it
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：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. |
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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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EQ-5D-5L
時間枠：change from baseline to 6-month follow up
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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
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Endometriosis Health Profile Questionnaire (EHP-5)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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Brief Pain Inventory - Short Form (BPI-SF), with higher scores indicating greater pain-related disability. |
change from baseline to 6-month follow up
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Psychological Pain Index (PPI)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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Somatic Symptom Disorder - B Criteria Scale (SSD-12), with higher scores indicating greater somatic symptom burden. |
change from baseline to 6-month follow up
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Pain Catastrophizing Scale (PCS)
時間枠：change from baseline to 6-month follow up
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Pain Catastrophizing Scale (PCS), with higher scores indicating greater pain catastrophizing. |
change from baseline to 6-month follow up
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Chronic Pain Acceptance Questionnaire (CPAQ)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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Acceptance and Action Questionnaire - II (AAQ-II), with higher scores indicating greater psychological inflexibility. |
change from baseline to 6-month follow up
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Cognitive Fusion Questionnaire (CFQ)
時間枠：change from baseline to 6-month follow up
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Cognitive Fusion Questionnaire (CFQ), with higher scores indicating greater cognitive fusion. |
change from baseline to 6-month follow up
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Cognitive Emotion Regulation Questionnaire (CERQ)
時間枠：change from baseline to 6-month follow up
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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
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Satisfaction with Life Scale (SWLS)
時間枠：change from baseline to 6-month follow up
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Satisfaction with Life Scale (SWLS), with higher scores indicating greater life satisfaction. |
change from baseline to 6-month follow up
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World Health Organization-Five Well-Being Index (WHO-5)
時間枠：change from baseline to 6-month follow up
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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
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Illness Attitudes Scale (IAS)
時間枠：change from baseline to 6-month follow up
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Illness Attitudes Scale (IAS), with higher scores indicating more dysfunctional illness-related attitudes. |
change from baseline to 6-month follow up
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Brief Illness Perception Questionnaire (BIPQ)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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Female Sexual Function Index (FSFI), with higher scores indicating better sexual functioning. |
change from baseline to 6-month follow up
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Chalder Fatigue Scale (CFS)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：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)
時間枠：change from baseline to 6-month follow up
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Beck Hopelessness Scale (BHS), with higher scores indicating greater hopelessness. |
change from baseline to 6-month follow up
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Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI)
時間枠：change from baseline to 6-month follow up
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Demoralization Scale (Psychiatric Epidemiology Research Interview - PERI), with higher scores indicating greater demoralization. |
change from baseline to 6-month follow up
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Frost Multidimensional Perfectionism Scale (FMPS)
時間枠：change from baseline to 6-month follow up
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Frost Multidimensional Perfectionism Scale (FMPS), with higher scores indicating higher levels of perfectionism. |
change from baseline to 6-month follow up
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Somatosensory Amplification Scale (SSAS)
時間枠：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
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Eating Disorder Inventory (EDI)
時間枠：change from baseline to 6-month follow up
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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)
時間枠：change from baseline to 6-month follow up
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Childhood Trauma Questionnaire - Short Form (CTQ-SF), with higher scores indicating greater exposure to childhood trauma. |
change from baseline to 6-month follow up
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Social Readjustment Rating Scale (SRRS)
時間枠：change from baseline to 6-month follow up
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Social Readjustment Rating Scale (SRRS), with higher scores indicating greater exposure to stressful life events. |
change from baseline to 6-month follow up
|
協力者と研究者
出版物と役立つリンク
一般刊行物
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- 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.
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研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- T-ENDO
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data will be shared upon request to the PI. Data can be shared as aggregated, anonymized information.
IPD 共有時間枠
From 01.01.2030 to 31.12.2030
IPD 共有アクセス基準
Researchers will be able to access.
IPD 共有サポート情報タイプ
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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