- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447089
EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study
March 2, 2026 updated by: Cesare Cavalera, Università Cattolica di Milano
Combination of the EMDR Integrative Group Protocol and Individual EMDR Treatment in Patients With Advanced Thyroid 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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cesare Cavalera
- Phone Number: +393409373408
- Email: cesarem.cavalera@unicatt.it
Study Locations
-
-
-
Milan, Italy, 20123
- Recruiting
- Università Cattolica del Sacro Cuore
-
Contact:
- Cesare Cavalera
- Phone Number: 3409373408
- Email: cesarem.cavalera@unicatt.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMDR Treatment Group
Participants receive an integrated EMDR intervention consisting of the EMDR Integrative Group Protocol (IGTP-OTS) followed by additional individual EMDR sessions when needed.
The treatment focuses on processing traumatic memories related to personal experiences cancer-related.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Baseline (T1) and Post-intervention (T2, approximately 1 month), Follow-up (T3, approximately 3 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Quaranta-Leech, A., Zaporozhets, O., Jarero, I., & Holland, D. (2025). Randomized Controlled Trial on the Provision of the EMDR-IGTP-OTS-R for Reduction of Posttraumatic Stress Disorder Symptomology with Mental Health Professionals in Ukraine during the War. Journal of EMDR Practice and Research, 19, 0007.
- Jarero, I., Artigas, L., Uribe, S., & García, L. E. (2016). The EMDR integrative group treatment protocol for patients with cancer. Journal of EMDR Practice and Research, 10(3), 199-207.
- Jarero, I., Givaudan, M., & Osorio, A. (2018). Randomized controlled trial on the provision of the EMDR integrative group treatment protocol adapted for ongoing traumatic stress to female patients with cancer-related posttraumatic stress disorder symptoms. Journal of EMDR Practice and Research, 12(3), 94-104.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 5, 2026
Study Registration Dates
First Submitted
February 25, 2026
First Submitted That Met QC Criteria
February 25, 2026
First Posted (Actual)
March 3, 2026
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Endocrine System Diseases
- Mental Disorders
- Neoplasms by Site
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Thyroid Diseases
- Stress Disorders, Traumatic
- Neoplasms
- Stress Disorders, Post-Traumatic
- Thyroid Neoplasms
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Desensitization, Psychologic
- Eye Movement Desensitization Reprocessing
Other Study ID Numbers
- CET 435-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data, after de-identification, will be shared with researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee
IPD Sharing Time Frame
Available between 2 months and 1 year following article publication.
IPD Sharing Access Criteria
Data will be provided in a de-identified format to ensure participant anonymity in accordance with EU General Data Protection Regulation (GDPR) and will be shared to researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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