A study to test whether a group EMDR therapy can reduce war-related stress in displaced people in Lebanon
| ISRCTN | ISRCTN57219158 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57219158 |
| Protocol serial number | CEC: 46/ 19.03.2025 |
| Sponsor | University of Bucharest |
| Funder | investigator initiated and funded |
- Submission date
- 03/05/2025
- Registration date
- 21/05/2025
- Last edited
- 20/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study explored whether the Eye Movement Desensitization and Reprocessing Group Traumatic Episode Protocol (EMDR G-TEP), a type of group therapy, could help young Lebanese adults who were forced to leave their homes during the 2024 Israeli war on Lebanon. The study included people born after the Lebanese civil war whose parents had lived through the war and who might also have been affected by its lasting impact. The study examined whether EMDR G-TEP reduced symptoms of posttraumatic stress, complex posttraumatic stress, anxiety, depression, and distress related to trauma passed from one generation to the next.
Who can participate?
The study included 70 eligible Lebanese adults aged 18 to 34 years who were born after the end of the Lebanese civil war (1991 onwards). Participants had to have lived in Lebanon since 2019, have been internally displaced from their homes due to the 2024 Israeli war on Lebanon, and have symptoms of both anxiety and depression and/or symptoms of posttraumatic stress or complex posttraumatic stress based on questionnaires completed in an earlier study. People who had been displaced before the major attacks in September 2024, moved into homes they already owned, or had been diagnosed with anxiety, depression, posttraumatic stress, or complex posttraumatic stress during the two years before September 2024 were not eligible. People who were receiving medication or psychological treatment for mental health problems, or who had psychosis, thoughts of suicide, substance dependence, or severe cognitive difficulties, also could not take part.
What does the study involve?
People who had taken part in an earlier related study, met the eligibility criteria, and agreed to be contacted again were invited by phone to take part. Those who agreed to participate were randomly assigned (by chance) to one of two groups. One group received the EMDR G-TEP therapy straight away, while the other group received the same therapy after a two-week wait. Before the therapy began, participants met with a trained mental health professional for a brief check to make sure it was safe and suitable for them to take part. The therapy was provided in small groups over two consecutive days and included four sessions (two sessions each day), with each session lasting up to two hours. The questionnaires completed in the earlier study were used as the starting point for the research. Participants in the group that waited for two weeks completed one additional online questionnaire at the end of the waiting period, just before starting the therapy. Participants in both groups then completed online questionnaires two weeks after the therapy and again one month later. These questionnaires asked about symptoms of anxiety, depression, posttraumatic stress, complex posttraumatic stress, and distress related to trauma passed down from the civil war.
What are the possible benefits and risks of participating?
Participants received free therapy that might have helped them manage trauma and emotional distress. The study also helped researchers learn more about how well this therapy worked for people affected by war and by trauma passed from one generation to the next. Answering the questionnaires or taking part in the therapy could have brought up upsetting memories or feelings. Participants could choose to skip any question and were free to leave a therapy session or withdraw from the study at any time. Support was available throughout the therapy, including one-on-one support if needed. All personal information was kept private and secure, and only summary findings were shared in reports or publications.
Where is the study run from?
The therapy sessions took place at community centers in Beirut and Mount Lebanon, Beqaa, and South Lebanon. All questionnaires were completed online.
When is the study starting and how long is it expected to run for?
March 2025 to July 2025
Who is funding the study?
This study is part of a PhD project and is not receiving any outside funding.
Who is the main contact?
Mrs Charlotte El Khalil, charlotte.el-khalil59@drd.unibuc.ro
Mr Johnny Moran, johnny@openmindscentre.ie
Contact information
Public, Scientific
Imaret Shalhoub, chant Building, 3rd floor
Zalqa
-
Lebanon
| 0009-0001-6156-9255 | |
| Phone | +961 3559777 |
| charlotte.el-khalil59@drd.unibuc.ro |
Principal investigator
Șoseaua Panduri 90 Romania
Bucharest
050663
Romania
| 0000-0001-5951-1401 | |
| Phone | +40314253445 |
| catalin.nedelcea@fpse.unibuc.ro |
Public, Scientific
10 Mellifont Ave, Dún Laoghaire
Dublin
A96 KE47
Ireland
| 0009-0008-8595-5119 | |
| Phone | +353 9025020 |
| johnny@openmindscentre.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter interventional open label randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effectiveness of EMDR Group Traumatic Episode Protocol (G-TEP) in reducing war-related distress among internally displaced Lebanese second-generation descendants: a randomised controlled trial |
| Study acronym | G-TEP RCT |
| Study objectives | Current study objectives as of 20/07/2026: Primary objective: To evaluate the effectiveness of EMDR G-TEP in reducing ICD-11 PTSD and CPTSD symptoms among Lebanese second-generation descendants internally displaced by the 2024 Israeli war Secondary objective: To evaluate the effectiveness of EMDR G-TEP in reducing symptoms of anxiety and depression and intergenerational trauma-related distress among Lebanese second-generation descendants internally displaced by the 2024 Israeli war _____ Previous study objectives: Hypothesis 1: EMDR G-TEP is effective in reducing war-related trauma symptoms (anxiety, depression, PTSD/CPTSD) among internally displaced second-generation Lebanese descendants Hypothesis 2: EMDR G-TEP is effective in reducing psychological distress related to intergenerational trauma from the Lebanese Civil War among internally displaced second-generation Lebanese descendants |
| Ethics approval(s) |
Approved 19/03/2025, The Scientific Research Ethics Committee of the University of Bucharest (Academic Street, Nr.14, Sector 5, Bucharest, 010014, Romania; +40213059730; cometc@unibuc.ro), ref: CEC: 46/19.03.2025 |
| Health condition(s) or problem(s) studied | Current condition as of 20/07/2026: EMDR intervention addressing symptoms of ICD-11 PTSD, complex PTSD (CPTSD), anxiety, depression, and intergenerational trauma-related distress among internally displaced Lebanese second-generation descendants. _____ Previous condition: EMDR intervention addressing symptoms of anxiety, depression, PTSD, complex PTSD and psychological distress related to intergenerational trauma from the Lebanese civil war in a sample of internally displaced Lebanese individuals. |
| Intervention | Current interventions as of 20/07/2026: This study was a follow-up study to a previous cross-sectional study examining the prevalence of probable anxiety, probable depression, probable PTSD, and probable CPTSD. Data collection for the prevalence study had already been completed. Participants who completed the prevalence study, screened positive for comorbid probable anxiety and depression and/or probable PTSD/CPTSD, and indicated their willingness to be contacted for this follow-up study were invited by phone to participate. During the phone conversation, each participant was assigned a unique study code and asked to read the information sheet and provide electronic informed consent to participate in the study. The LimeSurvey link to the information sheet and informed consent form was sent to each participant following the phone call. Of the 70 eligible participants, 48 provided informed consent and were randomly assigned within each of the three strata (Beirut and Mount Lebanon, Beqaa, and South Lebanon) to either an immediate intervention group (n = 24) or a delayed intervention (two-week waitlist) group (n = 24). Before the intervention began, 10 participants withdrew due to family or work commitments, resulting in a final sample of 38 participants (18 immediate intervention and 20 delayed intervention). On the day of the intervention, participants completed an in-person eligibility screening. This brief 10-minute screening was conducted by trained Emotional Protection Workers (licensed clinical psychologists) using a standardized set of questions adapted from the Structured Clinical Interview for DSM-5 (SCID-5), together with additional questions informed by standard clinical practice. The purpose of this screening was to determine whether participants met any of the study’s exclusion criteria, which included the presence of active psychosis, current treatment (e.g., psychotropic medication or psychotherapy), suicidal ideation, substance dependence, or severe cognitive impairment. Participants who met any of these exclusion criteria would not have proceeded with the intervention and would have been provided with a list of free or low-cost mental health resources in Lebanon to support them. However, no participants met these exclusion criteria, and all screened participants proceeded with the intervention as planned. • Immediate Intervention Group: Participants assigned to the immediate intervention group received EMDR group therapy in small groups over four sessions held across two consecutive days (two sessions per day). Each session lasted up to two hours. Two weeks after the final EMDR session, participants completed an online post-intervention assessment (T1) via LimeSurvey assessing symptoms of anxiety using the GAD-7, depression using the PHQ-9, ICD-11 PTSD and CPTSD using the ITQ, and intergenerational trauma-related distress related to the Lebanese civil war using the adapted HITTQ. One month after the post-test, participants completed an online follow-up assessment (T2) via LimeSurvey assessing the same outcomes. This study included three immediate intervention groups: one in Beirut and Mount Lebanon, one in South Lebanon, and one in the Beqaa region. • Delayed Intervention Group: Participants assigned to the delayed intervention group waited for two weeks without receiving any structured psychological intervention. Following this waiting period, they completed a pre-intervention online assessment (T0) via LimeSurvey assessing symptoms of anxiety using the GAD-7, depression using the PHQ-9, PTSD/CPTSD using the ITQ, and intergenerational trauma-related distress related to the Lebanese civil war using the adapted HITTQ. Participants then received the same EMDR group therapy delivered in small groups over four sessions held across two consecutive days (two sessions per day), with each session lasting up to two hours. Two weeks after the final EMDR session, participants completed an online post-intervention assessment (T1), followed by an online follow-up assessment (T2) via LimeSurvey one month later, assessing the same outcomes. This study included three delayed intervention groups: one in Beirut and Mount Lebanon, one in South Lebanon, and one in the Beqaa region. The intervention was delivered by the research investigator, Mrs. Charlotte El Khalil, an EMDRIA-certified EMDR therapist, and two licensed clinical psychologists serving as Emotional Protection Workers (EPWs). _____ Previous interventions: This study is a follow-up study (study II) to a previous study (study I) on the prevalence of anxiety, depression, PTSD/CPTSD. It is noteworthy that the data collection for study I (the prevalence study) had been completed. Participants who completed study I and who were found to have a comorbid anxiety and depression, and/or PTSD/CPTSD, and indicated their willingness to be contacted for this follow-up study (study II) will be invited by phone to participate in this study. During the phone conversation, each participant will be assigned a unique study code and asked to read the information sheet and provide consent to participate in the study. The LimeSurvey link to the information sheet and informed consent form will be sent to each participant directly the phone call. Upon their consent to participate, participants, in each of the three strata (Beirut, Beqaa, and South Lebanon), will be randomly assigned to one of two groups: an immediate intervention group or a delayed treatment control group. It is important to note that on the day of the intervention, participants will be asked to complete an initial eligibility screening in person. This brief 10-minute screening will be conducted by the research team using a standardized set of questions adapted from the Structured Clinical Interview for DSM-5 (SCID-5), along with additional items informed by standard clinical practice. The purpose of this screening is to determine whether each participant meet any of the study’s exclusion criteria, which include the presence of psychotic symptoms, current treatment (e.g., psychotropic medications or psychotherapy), active suicidal ideation, alcohol or substance dependence, or severe cognitive impairment. If any of these exclusion criteria are met, this participants will not proceed with the intervention; however, they will be provided with a list of free or low-cost mental health resources in Lebanon to support them. If none of the exclusion criteria are met, they will be eligible to continue with the study as planned. • Immediate Intervention Group: If the participant was assigned to the immediate intervention group, they will participate in EMDR group therapy with up to 12 participants over four sessions, held across two consecutive days (two sessions per day). Each session will last between 1.5 and 2 hours. Two weeks after the final EMDR session, this participant will be asked to complete an online post-test questionnaire (T1) via Lime Survey, which will measure symptoms of anxiety using the GAD-7, depression using the PHQ-9, PTSD/CPTSD using the ITQ, and psychological distress related to intergenerational trauma from the Lebanese civil war. One month after the post-test, this participant will be asked to complete a follow-up questionnaire online (T2) via Lime Survey, which will also assess symptoms of anxiety, depression, PTSD/CPTSD, and psychological distress related to intergenerational trauma from the Lebanese civil war, using the same questionnaires. We estimate that completing these measures at T1 and T2 will take 8-10 minutes each. Please note that this study includes a total of three immediate intervention groups, one in Beirut, one in South Lebanon, and one in the Beqaa region, each consisting of up to 12 participants. • Delayed Treatment Group: If the participant was assigned to the delayed treatment group, they will be asked to wait for two weeks without receiving any intervention. After this waiting period, they will be asked to complete a pre-test online questionnaire (T0) via Lime Survey, measuring symptoms of anxiety using the GAD-7, depression using the PHQ-9, PTSD/CPTSD using the ITQ, and psychological distress related to intergenerational trauma from the Lebanese civil war. Following the pre-test, this participant will participate in the EMDR group therapy with up to 12 participants over four sessions, held across two consecutive days (two sessions per day). Each session will last between 1.5 to 2 hours. Two weeks after the final EMDR session, they will be asked to complete an online post-test questionnaire (T1), which will measure symptoms of anxiety, depression, PTSD/CPTSD, and psychological distress related to intergenerational trauma from the Lebanese civil war, using the same questionnaires. One month after the post-test, they will be asked to complete a follow-up questionnaire online (T2) via Lime Survey, which will also assess symptoms of anxiety, depression, PTSD/CPTSD, and psychological distress related to intergenerational trauma from the Lebanese civil war, using the same questionnaires. We estimate that completing these measures at T0, T1, and T2 will take 8-10 minutes each. Please note that this study includes a total of three delayed treatment groups, one in Beirut, one in South Lebanon, and one in the Beqaa region, each consisting of 12 participants. The co-investigator, Mrs. Charlotte El Khalil, who will be responsible for administering EMDR G-TEP in this study, is a licensed psychologist and psychotherapist in Lebanon, and an EMDRIA (EMDR International Association) Certified Therapist. Mrs. El Khalil is also trained in administering EMDR Group Traumatic Episode Protocol (G-TEP). Notably, two facilitators, also licensed clinical psychologists, will accompany Mrs. El Khalil during the EMDR intervention. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcome(s) as of 20/07/2026: |
| Key secondary outcome measure(s) |
Current key secondary outcome(s) as of 20/07/2026: |
| Completion date | 10/07/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 34 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Total final enrolment | 48 |
| Key inclusion criteria | Current key inclusion criteria as of 20/07/2026: 1. Lebanese nationality 2. Adult, born after the end of the civil war (1991 and beyond), aged between 18 and 34 years 3. Residing in Lebanon for the past six years (i.e., from 2019 to the present) 4. Internally displaced from their home due to the recent Israeli war on Lebanon, which escalated in September 2024 5. Had screening scores indicative of comorbid probable anxiety and depression and/or probable PTSD/CPTSD _____ Previous key inclusion criteria: 1. Lebanese nationality 2. Adult, born after the end of the civil war (1991 and beyond), aged between 18 and 34 years 3. Residing in Lebanon for the past six years (i.e., from 2019 to the present) 4. Displaced from their home due to the recent Israeli war on Lebanon, which escalated in September 2024 5. Had scores indicative of comorbid anxiety and depression and/or PTSD/CPTSD |
| Key exclusion criteria | Current key exclusion criteria as of 20/07/2026: 1. Experiencing displacement between October 8th, 2023, and August 2024, during the Israeli strikes on villages along the Lebanese border, prior to the large-scale Israeli strike across Lebanon that began in September 2024 2. During displacement, moving to a house that the participant owned in the area of displacement 3. Having been diagnosed by a mental health professional (psychologist or psychiatrist) with depression, anxiety, or PTSD/CPTSD within the two years prior to the escalation of the Israeli war on Lebanon in September 2024 4. Active psychotic symtoms 5. Currently receiving treatment such as medication, psychotherapy, or similar interventions 6. Active suicidal ideation 7. Alcohol/substance dependency 8. Severe cognitive impairment _____ Previous key exclusion criteria: 1. Experiencing displacement between October 8th, 2023, and August 2024, during the Israeli strikes on villages along the Lebanese border, prior to the large-scale Israeli strike across Lebanon that began in September 2024 2. During displacement, moving to a house that you own in the area of displacement 3. Having been diagnosed by a mental health professional (psychologist or psychiatrist) with depression, anxiety, or PTSD/CPTSD within the two years prior to the escalation of the Israeli war on Lebanon in September 2024 4. Active psychotic symtoms 5. Currently receiving treatment such as medication, psychotherapy, or similar interventions 6. Active suicidal ideation 7. Alcohol/substance dependency 8. Severe cognitive impairment |
| Date of first enrolment | 20/03/2025 |
| Date of final enrolment | 30/04/2025 |
Locations
Countries of recruitment
- Lebanon
Study participating centre
Lebanon
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the results publication. |
Editorial Notes
20/07/2026: The following changes were made to the study record:
1. The scientific title was changed from "Effectiveness of EMDR Group Traumatic Episode Protocol (G-TEP) in reducing war-related distress among internally displaced Lebanese: a randomized controlled trial" to "Effectiveness of EMDR Group Traumatic Episode Protocol (G-TEP) in reducing war-related distress among internally displaced Lebanese second-generation descendants: a randomised controlled trial".
2. The study objectives were changed.
3. The Health condition(s) or problem(s) studied was changed.
4. The interventions were changed.
5. The primary outcome(s) were changed.
6. The key secondary outcome(s) were changed.
7. The total final enrolment was changed from 70 to 48.
8. The key inclusion criteria were changed.
9. The key exclusion criteria were changed.
10. The plain English summary was updated to reflect these changes.
19/08/2025: The completion date was changed from 31/08/2025 to 10/07/2025.
18/06/2025: Contact details updated.
06/05/2025: Trial's existence confirmed by The Scientific Research Ethics Committee of the University Of Bucharest.