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

NCT07481890 | Recruiting DMC

• 1 other identifier: 2025-02633
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer; Psychological Distress

Keywords

Cancer; Eye Movement Desensitization and Reprocessing; Psychosomatics; EMDR Toolbox Method; Trauma-focused psychotherapy; Psychotherapy

Outcome Measures

Primary Outcomes (3)

• Feasibility outcome

  Feasibility will be evaluated in this pilot randomized controlled trial comparing Standard EMDR and EMDR Toolbox Method delivered over 15 sessions. Feasibility indicators will include: \- Treatment adherence (proportion of participants attending at least 10 out of 15 sessions) Feasibility criteria will be considered met if: \- ≥65% of randomized participants complete at least 10 out of 15 sessions

  From randomization (week 0) to post-treatment assessment (approximately 28 weeks).

• Change in Overall Psychological Wellbeing as Measured by CORE-OM Total Score

  Overall psychological wellbeing will be assessed using the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) total score \[range score: 0-136\]. The CORE-OM is a self-report measure of global psychological distress and functioning, with higher scores indicating greater psychological distress. Assessments will be conducted at three time points: * Baseline (prior to randomization) * Mid-treatment (after 7 sessions; approximately 14 weeks post-randomization) * Post-treatment (after 15 sessions; approximately 28 weeks post-randomization) The primary analysis for this pilot study will estimate within-group and between-group mean changes in CORE-OM total scores over time. Effect size estimates (e.g., Cohen's d) and 95% confidence intervals will be calculated to inform the design and sample size estimation of a future definitive trial.

  Baseline, 14 weeks (mid-treatment), and 28 weeks (post-treatment).

• Change in Psychological Symptoms as Measured by CORE-OM Symptoms Subscale

  Psychological symptoms will be assessed using the Symptoms subscale of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) \[range score: 0-48\]. The Symptoms domain evaluates the severity of psychological distress, including anxiety, depression, trauma-related and somatic symptoms. Higher scores indicate greater symptom severity. Assessments will be conducted at three time points: * Baseline (prior to randomization) * Mid-treatment (after 7 sessions; approximately 14 weeks post-randomization) * Post-treatment (after 15 sessions; approximately 28 weeks post-randomization) For this trial comparing Standard EMDR and ETM EMDR, analyses will estimate: * Within-group mean changes over time * Between-group differences in change scores * Effect size estimates (e.g., Cohen's d) with 95% confidence intervals

  Baseline (randomization, week 0), 14 weeks (mid-treatment, session 7, week 14), and 28 weeks (post-treatment, session 15, week 28).

Secondary Outcomes (2)

• Change in Self-Compassion as Measured by the Self-Compassion Scale (SCS) Total Score

  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)

  From enrollment to the end of study (7 sessions, 14 weeks (mid-treatment, session 7, week 14), 15 sessions or drop out)

Study Arms (2)

STANDARD EMDR

ACTIVE COMPARATOR

Participants receive standard EMDR therapy following the standard EMDR protocol (Shapiro, 2002).

Behavioral: STANDARD EMDR

EMDR TOOLBOX METHOD

EXPERIMENTAL

Participants receive EMDR therapy using the EMDR Toolbox Method including the Ovals Tool as a case formulation tool and additional tools tools such as Loving Eyes (LE) and Constant Installation of Present Orientation and Safety (CIPOS).

Behavioral: EMDR TOOLBOX METHOD

Interventions

STANDARD EMDR BEHAVIORAL

Standard Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered according to established clinical guidelines (Shapiro, 2002).

STANDARD EMDR

EMDR TOOLBOX METHOD BEHAVIORAL

Eye Movement Desensitization and Reprocessing (EMDR) delivered using the EMDR Toolbox Method (Knipe, 2018; Spadoni, 2026).

EMDR TOOLBOX METHOD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lega Cancro Ticino: lead

Study Sites (2)

Lega cancro Ticino

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Lega Cancro Ticino

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Related Publications (14)

• Arnaboldi P,Massari I,Lombardi E,Cavallo M

  BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Shapiro F. The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences. Perm J. 2014 Winter;18(1):71-7. doi: 10.7812/TPP/13-098.

  PMID: 24626074 BACKGROUND

• Hinnen C, von Haeseler E, Tijssens F, Mols F. Adverse childhood events and mental health problems in cancer survivors: a systematic review. Support Care Cancer. 2024 Jan 4;32(1):80. doi: 10.1007/s00520-023-08280-7.

  PMID: 38175303 BACKGROUND

• Cocchi M, Girone N, Leonardi M, Achilli F, Benatti B, dell'Osso B. Evaluation of Adherence to Pharmacological Treatment in a Large Sample of Patients with Personality Disorder. Clin Neuropsychiatry. 2025 Aug;22(4):279-286. doi: 10.36131/cnfioritieditore20250402.

  PMID: 40989040 BACKGROUND

• Carlson EB, Putnam FW, Ross CA, Torem M, Coons P, Dill DL, Loewenstein RJ, Braun BG. Validity of the Dissociative Experiences Scale in screening for multiple personality disorder: a multicenter study. Am J Psychiatry. 1993 Jul;150(7):1030-6. doi: 10.1176/ajp.150.7.1030.

  PMID: 8317572 BACKGROUND

• Brown MJ, Thacker LR, Cohen SA. Association between adverse childhood experiences and diagnosis of cancer. PLoS One. 2013 Jun 11;8(6):e65524. doi: 10.1371/journal.pone.0065524. Print 2013.

  PMID: 23776494 BACKGROUND

• Bremner JD. Effects of traumatic stress on brain structure and function: relevance to early responses to trauma. J Trauma Dissociation. 2005;6(2):51-68. doi: 10.1300/J229v06n02_06.

  PMID: 16150669 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paola Arnaboldi

  Lega Cancro Ticino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Arnaboldi, PsyD

CONTACT

+41782192859; paola.arnaboldi@legacancro-ti.ch

Loredana Turri, MSc

CONTACT

+410918206420

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 19, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)