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Completed

NCT Number: NCT07731906

EMDR Group Therapy for Posttraumatic Stress Symptoms in Migrants

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Provinciale Istruzione Adulti Salerno "Paulo Freire"

Salerno, Italy, 84131

About this study

Posttraumatic stress symptoms are highly prevalent among migrants who have experienced potentially traumatic events during their life course and migration trajectories. These symptoms may negatively affect psychological functioning, adaptation, and participation in educational and social contexts. The present randomized controlled trial evaluates the effectiveness and feasibility of the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in reducing posttraumatic stress symptoms and psychological distress among adult migrants attending an adult education center (CPIA Salerno) in Italy.

The EMDR-IGTP-OTS is a structured group intervention based on the principles of Eye Movement Desensitization and Reprocessing (EMDR), adapted for individuals exposed to ongoing traumatic stress and for group-based delivery. The intervention is designed to facilitate the processing of traumatic memories and reduce trauma-related emotional distress through standardized therapeutic procedures conducted in a group format.

Participants are randomly assigned to an intervention group receiving EMDR-IGTP-OTS or to a control condition. The study examines whether participation in the intervention is associated with greater improvements in posttraumatic stress symptoms and psychological distress compared with the control condition. Assessments are conducted before the intervention, after completion of the intervention, and at follow-up to evaluate changes over time.

The primary endpoints are between-group differences in post-intervention posttraumatic stress symptoms assessed using the Impact of Event Scale-Revised (IES-R) and the Short PTSD Rating Interview (SPRINT). Secondary endpoints include: (a) between-group differences in change scores on the Clinical Outcomes in Routine Evaluation-10 (CORE-10), a measure of global psychological distress; (b) treatment completion, defined as attendance at ≥80% of scheduled EMDR-IGTP-OTS sessions among participants assigned to the intervention condition; and (c) protocol adherence, assessed through therapist session logs documenting fidelity to each phase of the intervention protocol.

The primary hypothesis is that participants receiving EMDR-IGTP-OTS will demonstrate greater reductions in posttraumatic stress symptoms compared with participants in the control condition. Secondary hypotheses concern improvements in global psychological distress and the feasibility of delivering the intervention in an adult education setting, including treatment completion and protocol adherence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    The Clinical Outcomes in Routine Evaluation-10 (CORE-10) is a 10-item self-report measure assessing global psychological distress. Items are rated on a 5-point response scale, producing total scores ranging from 0 to 40, with higher scores indicating greater distress.

  2. Protocol adherence to the EMDR-IGTP-OTS intervention

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

    Protocol adherence was assessed through therapist session logs documenting the completion of predefined intervention components and fidelity to each phase of the EMDR-IGTP-OTS protocol. This measure was used to evaluate intervention delivery fidelity.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Salerno

Other

Registry information

Official study title

Effectiveness of an EMDR-IGTP-OTS Intervention for Posttraumatic Symptoms in Migrants Attending an Adult Education Center: A Pilot Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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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