NCT07447089

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 5, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2026

Last Updated

March 4, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

Thyroid NeoplasmsNeoplasmPost-traumatic Stress Disorder (PTSD)Psychological Distress

Keywords

PsychoncologyCancer

Outcome Measures

Primary Outcomes (1)

  • Impact of Event Scale-Revised (IES-R)

    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)

Study Arms (1)

EMDR Treatment Group

EXPERIMENTAL

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.

Behavioral: EMDR-IGTP-OTS

Interventions

EMDR-IGTP-OTSBEHAVIORAL

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.

Also known as: EMDR (classic individual setting)
EMDR Treatment Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Cattolica del Sacro Cuore

Milan, 20123, Italy

RECRUITING

Related Publications (3)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Thyroid NeoplasmsNeoplasmsStress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Cesare Cavalera

CONTACT

+393409373408cesarem.cavalera@unicatt.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor (tenure track)

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

December 5, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 5, 2026

Last Updated

March 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
SAP
Time Frame
Available between 2 months and 1 year following article publication.
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

Locations

IT(1)