EMDR Group Therapy for Posttraumatic Stress Symptoms in Migrants

NCT07731906 | Completed

• 1 other identifier: 87271/2025
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to evaluate the effectiveness and feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in migrants with posttraumatic stress symptoms attending an adult education center (CPIA Salerno) in Italy. The main questions it aims to answer are:

• Do participants who receive the EMDR-IGTP-OTS intervention show greater reductions in posttraumatic stress symptoms compared with participants assigned to a control condition?
• Does the intervention lead to improvements in psychological distress and broader psychological functioning over time?
• Is the EMDR-IGTP-OTS intervention feasible in an adult education setting, as indicated by treatment completion and adherence to the intervention protocol? Researchers will compare participants receiving the EMDR-IGTP-OTS group intervention with participants assigned to a control condition to determine whether the intervention is effective in reducing posttraumatic stress symptoms and psychological distress. Participants will:
• Complete questionnaires assessing posttraumatic stress symptoms and psychological distress before the intervention, after the intervention, and at follow-up.
• Participate in four structured group sessions of EMDR-IGTP-OTS delivered on consecutive days.
• Be monitored for treatment completion and protocol adherence throughout the intervention period.

Conditions

Posttraumatic Stress Disorder (PTSD); Trauma and Stressor Related Disorders; Psychological Distress

Keywords

EMDR-IGTP-OTS; Posttraumatic Stress Symptoms; Migrants; Ongoing Traumatic Stress; Trauma-Focused Intervention; Randomized Controlled Trial; Educational Setting

Outcome Measures

Primary Outcomes (2)

• Change in posttraumatic stress symptoms assessed by the Impact of Event Scale-Revised (IES-R)

  The Impact of Event Scale-Revised (IES-R) is a 22-item self-report measure assessing posttraumatic stress symptoms across three domains: intrusion, avoidance, and hyperarousal. Total scores range from 0 to 88, with higher scores indicating greater symptom severity.

  Baseline, immediately after completion of the 4-day intervention (Day 4), and 30 days after completion of the intervention.

• Change in posttraumatic stress symptoms assessed by the Short PTSD Rating Interview (SPRINT)

  The Short PTSD Rating Interview (SPRINT) is an eight-item measure assessing posttraumatic stress symptom severity, distress, and functional impairment. Total scores range from 0 to 32, with higher scores indicating greater symptom severity.

  Baseline, immediately after completion of the 4-day intervention (Day 4), and 30 days after completion of the intervention.

Secondary Outcomes (2)

• Change in global psychological distress assessed by the Clinical Outcomes in Routine Evaluation-10 (CORE-10)

  Baseline, immediately after completion of the 4-day intervention (Day 4), and 30 days after completion of the intervention.

• Protocol adherence to the EMDR-IGTP-OTS intervention

  Assessed during each of the four consecutive intervention sessions (Days 1-4).

Study Arms (2)

EMDR-IGTP-OTS intervention group

EXPERIMENTAL

Participants assigned to this arm received the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS), a structured group intervention designed to reduce posttraumatic stress symptoms and trauma-related distress. The intervention consisted of four group sessions delivered on consecutive days.

Behavioral: Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS)

Waitlist Control Condition

NO INTERVENTION

Participants assigned to this arm were placed on a waitlist and did not receive the EMDR-IGTP-OTS intervention during the study comparison period.

Interventions

Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) BEHAVIORAL

The Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) is a structured group behavioral intervention based on the principles of Eye Movement Desensitization and Reprocessing (EMDR). The protocol is specifically adapted for individuals exposed to ongoing traumatic stress and is designed for delivery in group settings. The intervention consists of four structured group sessions delivered on consecutive days, following standardized procedures that include trauma processing, a form of art therapy, and bilateral stimulation techniques. The intervention aims to reduce posttraumatic stress symptoms and trauma-related distress.

EMDR-IGTP-OTS intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in courses at CPIA Salerno (adult education center).
• Age ≥16 years.
• Sufficient Italian or English language proficiency to complete study procedures.
• Provision of informed consent.
• Clinically significant posttraumatic stress symptoms, defined as an Impact of Event Scale-Revised (IES-R) score ≥24 or a Short PTSD Rating Interview (SPRINT) score ≥14 at baseline.

You may not qualify if:

• Current self-harm behavior or suicidal or homicidal ideation.
• Substance abuse.
• Psychotic disorders, bipolar disorders, or organic mental disorders.
• Lack of adequate structural or functional support.
• Significant cognitive impairment affecting participation in study procedures.

Sponsors & Collaborators

• Azienda Sanitaria Locale Salerno: lead

Study Sites (1)

Centro Provinciale Istruzione Adulti Salerno "Paulo Freire"

Salerno, Italy, 84131, Italy

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was used due to the nature of the behavioral intervention. Participants assigned to the EMDR-IGTP-OTS group and intervention providers were aware of treatment allocation. Investigators involved in intervention delivery were also aware of group assignment. Outcome measures were collected through standardized participant-reported questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to either the EMDR-IGTP-OTS intervention group or a waitlist control condition. The study followed a parallel-group design, with both groups assessed at baseline, post-intervention, and 30-day follow-up. Participants assigned to the waitlist control condition did not receive the intervention during the study comparison period.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 28, 2026
• Study Start: December 3, 2025
• Primary Completion: February 26, 2026
• Study Completion: May 28, 2026
• Last Updated: July 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning immediately following publication, with no planned end date.
• Access Criteria: Deidentified individual participant data and supporting documentation (study protocol, statistical analysis plan, and analytic code) will be publicly available through the study's Open Science Framework (OSF) repository following publication of the primary study results. Data will be shared in a deidentified format in accordance with the informed consent provided by participants, applicable privacy regulations, and ethical approval.

Locations

IT (1)