Posttraumatic Stress Disorder (PTSD)NCT07731906
EMDR Group Therapy for Posttraumatic Stress Symptoms in Migrants
A study testing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in people with Posttraumatic Stress Disorder (PTSD) and Trauma and Stressor Related Disorders, run by Azienda Sanitaria Locale Salerno at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Trauma and Stressor Related Disorders, Psychological Distress
- What is being tested?
- Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2025to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro Provinciale Istruzione Adulti Salerno "Paulo Freire"
Salerno, Italy, 84131
About this study
Official title: Effectiveness of an EMDR-IGTP-OTS Intervention for Posttraumatic Symptoms in Migrants Attending an Adult Education Center: A Pilot Randomized Controlled Trial
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Posttraumatic Stress Disorder (PTSD), Trauma and Stressor Related Disorders, Psychological Distress
- Being tested
- Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS)
- Keywords
- EMDR-IGTP-OTS, Posttraumatic Stress Symptoms, Migrants, Ongoing Traumatic Stress, Trauma-Focused Intervention, Randomized Controlled Trial, Educational Setting
- Medical subject headings
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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
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.
Measured: Assessed during each of the four consecutive intervention sessions (Days 1-4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start3 Dec 2025
- Primary completion26 Feb 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731906
- Sponsor's protocol ID
- 87271/2025
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the reported results will be shared, including demographic characteristics, baseline clinical characteristics, intervention allocation, and outcome measures collected at baseline, post-intervention, and 30-day follow-up. Shared outcome data will include scores from the Impact of Event Scale-Revised (IES-R), Short PTSD Rating Interview (SPRINT), and Clinical Outcomes in Routine Evaluation-10 (CORE-10).
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an EMDR-IGTP-OTS Intervention for Posttraumatic Symptoms in Migrants Attending an Adult Education Center: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07731906
- Acronym / sponsor ID
- 87271/2025
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale SalernoUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMDR-IGTP-OTS intervention group | Experimental | Behavioral: Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS)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. |
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS)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. | Behavioural | EMDR-IGTP-OTS intervention group |
Primary outcome
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.
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.
2 secondary outcomes
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.
Protocol adherence to the EMDR-IGTP-OTS intervention
Time frame: Assessed during each of the four consecutive intervention sessions (Days 1-4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the reported results will be shared, including demographic characteristics, baseline clinical characteristics, intervention allocation, and outcome measures collected at baseline, post-intervention, and 30-day follow-up. Shared outcome data will include scores from the Impact of Event Scale-Revised (IES-R), Short PTSD Rating Interview (SPRINT), and Clinical Outcomes in Routine Evaluation-10 (CORE-10).
Related trials for Posttraumatic Stress Disorder (PTSD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Group Treatment Protocol for Ongoing Traumatic Stress (EMDR-IGTP-OTS) in people with Posttraumatic Stress Disorder (PTSD) and Trauma and Stressor Related Disorders, run by Azienda Sanitaria Locale Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.