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NCT Number: NCT07447089

EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study

The main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures.

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Key information

Conditions

Thyroid Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Mental Disorders Neoplasm Neoplasms Neoplasms by Site Post-traumatic Stress Disorder (PTSD) Psychological Distress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Thyroid Diseases Trauma and Stressor Related Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università Cattolica del Sacro Cuore

Milan, 20123, Italy

Location status: Recruiting

Location contact

Cesare Cavalera

CONTACT

[email protected]

3409373408

About this study

The diagnosis of cancer represents a potentially life-threatening event that can be considered a unique traumatic stressor. A cancer diagnosis can disrupt a person's life, affecting emotions, cognition, and physical pain impacting the individual sense of identity. Findings from the literature suggest that EMDR can be a valid treatment in the processing of cancer-related traumatic events. With this proposal, the investigators aim to evaluate the feasibility and the effects of a combined EMDR Integrative Group Treatment Protocol and an optional EMDR individual protocol for people with cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • cancer diagnosis
  • PTSD (IES-R > 32)

Exclusion criteria

  • receiving specialized trauma therapy
  • receiving current psychiatric pharmacological treatment, unless the dosage has been stable for at least 2 months prior to enrollment

Treatment and study plan

EMDR-IGTP-OTS

Behavioral

The intervention follows the EMDR 8-phase protocol as indicated by Jarero et al. (2018). The group sessions use the IGTP-OTS (Integrative Group Treatment Protocol for Ongoing Traumatic Stress) to provide early stabilization.

Other names: EMDR (classic individual setting)

Primary outcomes

  1. Impact of Event Scale-Revised (IES-R)

    Time frame: Baseline (T1) and Post-intervention (T2, approximately 1 month), Follow-up (T3, approximately 3 month)

    Impact of Event Scale-Revised range: The scale is composed by 22 items, each scored 0-4 (Min Score: 0; Max Score: 88).

    A higher score indicates a higher intensity of post-traumatic stress symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Cesare Cavalera

CONTACT

[email protected]

+393409373408

Sponsors and collaborators

Lead sponsor

Università Cattolica di Milano

Other

Collaborators

  • ASST Santi Paolo e Carlo

Registry information

Official study title

Combination of the EMDR Integrative Group Protocol and Individual EMDR Treatment in Patients With Advanced Thyroid Cancer: A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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