Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients.

Официальное название

Feasibility and Efficacy of an EMDR Psychotherapeutic Intervention With Additional Procedures (EMDR Toolbox Method) in Improving the Psychological Well-Being of Patients Diagnosed With Oncological Disease: A Randomized Study.

Обзор

The incidence of adverse childhood experiences (ACEs) is significantly elevated in patients affected by organic diseases (Riedl, 2020). Adverse childhood experiences include life events such as physical, emotional, and sexual abuse; exposure to domestic violence; abandonment; and physical and emotional neglect occurring during early stages of life. One of the primary and most extensively studied mechanisms through which ACEs appear to influence the development of organic diseases across the lifespan is dysregulation of cortisol levels, which acts as a key mediator of increased macro- and microcellular inflammatory processes. In rhis context, it is important to integrate the standard triage and psychological distress screening interventions routinely provided by psychologists working in clinical liaison psychology services with specialized, evidence-based psychotherapeutic treatments delivered by appropriately trained professionals. Among the range of evidence-based psychotherapies currently available, Eye Movement Desensitization and Reprocessing (EMDR) psychotherapy-hereafter referred to as EMDR-was recognized by the World Health Organization (WHO) in 2013 and reaffirmed in 2024 as one of the treatments of choice for trauma and the psychophysiological consequences of adverse events. Since 2015, Manuela Spadoni has systematized the empirical evidence, theoretical concepts, the parts model, and the operational tools of the additional EMDR procedures introduced by Jim Knipe beginning in 2001 into a structured psychotherapeutic approach known as the EMDR Toolbox method. This method appears to be particularly well suited for treating individuals whose clinical history is characterized by multiple adverse experiences. The present randomized trial aims to evaluate the feasibility and efficacy of the EMDR Toolbox Method (ETM) in patients diagnosed with oncological disease.

Вмешательства

• Поведенческое STANDARD EMDR
  Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002).
• Поведенческое EMDR TOOLBOX METHOD
  Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026).

Первичные конечные точки

• Feasibility outcome [Срок оценки: From randomization (week 0) to post-treatment assessment (approximately 28 weeks).]
• Change in Overall Psychological Wellbeing as Measured by CORE-OM Total Score [Срок оценки: Baseline, 14 weeks (mid-treatment), and 28 weeks (post-treatment).]
• Change in Psychological Symptoms as Measured by CORE-OM Symptoms Subscale [Срок оценки: Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).]

Вторичные конечные точки (2)

• Change in Self-Compassion as Measured by the Self-Compassion Scale (SCS) Total Score [Срок оценки: Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).]
• Change in Perceived Nighttime Rest Quality as Measured by a Study-Specific Visual Analog Scale (VAS) [Срок оценки: From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out)]

Критерии участия

Критерии включения

• Clinical stage of the tumor: Stage I, II (TNM classification)
• Age ≥ 18 years <=65
• Conditions enabling correct implementation of the proposed program (ability to complete questionnaires)
• Written informed consent

Критерии исключения

• Psychiatric or other disorders that may impair the ability to provide informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 2 центра

• Lega cancro Ticino — Bellinzona
• Lega Cancro Ticino — Bellinzona

Публикации

• Arnaboldi P, Massari I, Lombardi E, Cavallo M. Prevalence of Personality Disorders in Cancer Patients: A Systematic Literature Review in the Era of Personalized Cancer Care. Cancers (Basel). 2025 Dec 5;17(24):3901. doi: 10.3390/cancers17243901. PMID 41463152
• Portigliatti Pomeri A, La Salvia A, Carletto S, Oliva F, Ostacoli L. EMDR in Cancer Patients: A Systematic Review. Front Psychol. 2021 Jan 18;11:590204. doi: 10.3389/fpsyg.2020.590204. eCollection 2020. PMID 33536968
• Manuela Spadoni, Paola Arnaboldi, Jim Knipe. The EMDR Toolbox Method (ETM): Expanding Jim Knipe's work and Enhancing the AIP Model. J EMDR Pract and Res. 0:DOI:10.34133/jemdr.0027
• Ramallo-Machin A, Gomez-Salas FJ, Burgos-Julian F, Santed-German MA, Gonzalez-Vazquez AI. Factors influencing quality of processing in EMDR therapy. Front Psychol. 2024 Sep 2;15:1432886. doi: 10.3389/fpsyg.2024.1432886. eCollection 2024. PMID 39286565
• Lutgendorf SK, Weinrib AZ, Penedo F, Russell D, DeGeest K, Costanzo ES, Henderson PJ, Sephton SE, Rohleder N, Lucci JA 3rd, Cole S, Sood AK, Lubaroff DM. Interleukin-6, cortisol, and depressive symptoms in ovarian cancer patients. J Clin Oncol. 2008 Oct 10;26(29):4820-7. doi: 10.1200/JCO.2007.14.1978. Epub 2008 Sep 8. PMID 18779606
• Inwood E, Ferrari M. Mechanisms of Change in the Relationship between Self-Compassion, Emotion Regulation, and Mental Health: A Systematic Review. Appl Psychol Health Well Being. 2018 Jul;10(2):215-235. doi: 10.1111/aphw.12127. Epub 2018 Apr 19. PMID 29673093
• Hughes K, Bellis MA, Hardcastle KA, Sethi D, Butchart A, Mikton C, Jones L, Dunne MP. The effect of multiple adverse childhood experiences on health: a systematic review and meta-analysis. Lancet Public Health. 2017 Aug;2(8):e356-e366. doi: 10.1016/S2468-2667(17)30118-4. Epub 2017 Jul 31. PMID 29253477
• Shapiro F, Maxfield L. Eye Movement Desensitization and Reprocessing (EMDR): information processing in the treatment of trauma. J Clin Psychol. 2002 Aug;58(8):933-46. doi: 10.1002/jclp.10068. PMID 12115716

Идентификаторы

NCT: NCT07481890 · 2025-02633

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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