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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (2)

Other trials for the same condition