Post-traumatic Stress Disorder (PTSD)SINDIANENCT05407337
The Effect of Narrative Exposure Therapy Intervention on Post-traumatic Stress Dissorder and Personal Recovery in Refugees and Asylum Seekers of Sindiane Programme
A study testing Psychotherapy using Narrative Exposure Therapy (NET) in people with Post-traumatic Stress Disorder (PTSD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Displaced people, like refugees or asylum seekers, have high rate of potentially traumatic events. PTSD is one of the most common psychiatric trouble in this population. It requires specialized support and psychosocial program. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- Psychotherapy using Narrative Exposure Therapy (NET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2022to 23 Apr 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 18
- Refugee or asylum seeker (habing applied to OFFPRA or with a residence permit)
- Belonging to the SINDIANE community project
- Having been exposed to at least one traumatic event (according to the DSM 5 definition validated by a doctor)
- Having a PCL5 score greater than 23
- Agreeing to participate in the study with an informed consent signed by the subject after explanations given by the investigating psychiatrist
- Patient affiliated to a social security health care
- Patient able to read and write arabic or french
Who cannot join
- Be under the age of 18
- Be included in another intervention research
- Presence of severe mental retardation or dementia according to DSM5
- Persons benefiting from special protection : under article L3212-1 and L3213-1 of the Public Health Code
- Persons referred to in articles L1121-5 to L1121-8 of the CSP
- Existence of a high suicide risk assessed by the R.U.D.
- Patient subject to a compulsory care measure (Law n°2011-803 of july 5, 2011 relating to the rights and protection of persons subject to psychiatric care and the terms of care)
- Patient refusing to sign the consent or unable to receive the information necessary to give informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux Marseille
Marseille, Bouches-du-Rhône, 13354
About this study
Official title: Single Center, Randomized, Comparative, Prospective Interventional Study Evaluating the Impact of Brief Psychotherapy by Narrative Exposure Therapy (NET) on the Reduction of Symptoms of Post Traumatic Stress Disorder in Refugee and Asylum Seeking Women in the Program SINDIANE in Marseille
Displaced people, like refugees or asylum seekers, have high rate of potentially traumatic events. PTSD is one of the most common psychiatric trouble in this population. It requires specialized support and psychosocial program. Narrative Exposure Therapy (NET), a german psychotherapy, was developed in the 2000 to specifically treat psycho-trauma in this population. It is brief, effective on complex trauma and can be delivered by trained non-caregivers. All published randomized studies have conclued that NET is effetive, but there are still insifficient numbers to make recomendations. To our knowledge, NET has never been tested in France. In Marseille, SINDIANE is a community support and program for refugees and asylum seekers. Many workshops led by peer workers are offered to increase empowerment of beneficiaries and hel them to recover. The development of a NET workshop would make it possible to combine community support and specific and validated psychotherapy. Through this study, the investigators hypothesize that tratment of PTSD with NET in the community-based SINDIANE program decrease symptoms of PTSD.
Read the detailed description
Methods and design Forty-six participants with a diagnosis of PTSD disorder within the SINDIANE program will be recruited. A prospective single-blind randomized clinical trial will be conducted comparing two groups, one participant in the classic SINDIANE program and one being treated in addition by NET workshp. The evaluations will be done at the baseline, after the intervention and at three and six months follow-up. IN addition, the qualitative and participatory research method called photovoice will be used to better understand the experiences of participants who recieve NETtroughout their recovery.
The primary objective is the assessment of the symptom intensity score (PCL-5) of posttraumatic stress disorder (PTSD).
Secondary objectives are represented by:
- The assessment of the stability over time of the PTSD symptom intensity score at three months and six months (PCL-5).
- Assessment of the intensity of global psychiatric comorbidities (RHS-15)
- Evaluation of life indicators: ability to act, quality of life (GSE self-efficacy questionnaire).
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Being tested
- Psychotherapy using Narrative Exposure Therapy (NET)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy using Narrative Exposure Therapy (NET)Behavioural
There are four NET sessions, each lasting thirty minutes and defined in advance on a weekly basis. The first session is the one where the person concerned will establish his/her "Life Line" and start his/her life story with the peer mediator.
The second and third session will be the one where the person will continue his life story. Each session will begin with the mediator reading the story from the previous session, with the person concerned modifying the story if they wish.
The fourth session will also start with the reading of the story from the previous session and will finish the story if necessary. It will also be the occasion to give the printed story to the person concerned at the end of the session and have it signed by the mediator and the patient.
To prevent a possible risk of decompensation of the subject during the session, there will be a psychiatrist on site at the time of the NET to be available if the patient needs it.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Beneficiaries of NET therapy + standard Sindiane program management. Receives: Behavioral: Psychotherapy using Narrative Exposure Therapy (NET) |
| Control group | No intervention | Beneficiaries of the standard care of the Sindiane program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms measure by PCL5
The PCL-5 is a self reported score. The higher the score, the greater intensity of the symptoms of PTSD. It is validated in english and french with goof psychometric characteristic. The total score of the questionnaire is 80. The scale varies per question from 0 to 4:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely
If the patient gets a 0, it means that he/she does not have this symptom of post-traumatic stress. On the contrary, the more the score increases and tends towards 4, the more the symptom will be present in the patient.
Measured: 1 month post NET therapy
Secondary outcomes (3)
Evolution of PCL5 score
Comparaison of the PCL-5 score after therapy and at 3 and 6 moth. This endpoint is intersted in highlighting a possible improvement in symptoms at a distance from the therapy.
The total score of the questionnaire is 80. The scale varies per question from 0 to 4:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely
If the patient gets a 0, it means that he/she does not have this symptom of post-traumatic stress. On the contrary, the more the score increases and tends towards 4, the more the symptom will be present in the patient.
Measured: 3 months and 6 months
Psychiatric comorbidity intensity score RHS15
Since post traumatic stress disorder is often accompanied by comorbid disorders such as depression or addictive behavior disorder. This evaluation will allow us to assess the possible effectiveness of NET on the associated disorder. This judgment criterion will be assessed using RHS15 wich is a self administrated questionnaire validated in the creening of the main psychiatric disorders.
The total of the base varies between 0 and 56. By question the scale varies between 0 and 4:
0 = Not at all
- = A little bit
- = Moderately
- = Quite a bit
- = Extremely A score of 0 means that the patient does not have a psychiatric disorder. The higher the score, the more the patient will have more and more mental disorders.
Measured: before the intervention, 1 month post therapy, 3 months and 6 months
EvExperience indicators intensity score (GSE)
This main judgment criterion is concerned with the overall functioning of person concerned. Indeed, it makes it possible to evaluate the satisfaction and the power to act of the person. It is used to have a broader assesment of the expected benefits of PTSD treatment.
The total score varies between 10 and 40. The more the patient scores, the higher his or her sense of self-efficacy.
Measured: before the intervention, 1 month post therapy, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start22 Nov 2022
- Primary completion23 Oct 2023
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique Hôpitaux MarseilleClotilde IZABELLE, Dr, Principal investigator, Assistance Publique Hôpitaux Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407337
- Sponsor's protocol ID
- 2021-A01172-39
- Acronym
- SINDIANE
- Status last verified
- Aug 2024
- First submitted
- 23 May 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized, Comparative, Prospective Interventional Study Evaluating the Impact of Brief Psychotherapy by Narrative Exposure Therapy (NET) on the Reduction of Symptoms of Post Traumatic Stress Disorder in Refugee and Asylum Seeking Women in the Program SINDIANE in Marseille
- ClinicalTrials.gov ID
- NCT05407337
- Acronym / sponsor ID
- SINDIANE / 2021-A01172-39
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 7 Jun 2022 (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.
Displaced people, like refugees or asylum seekers, have high rate of potentially traumatic events. PTSD is one of the most common psychiatric trouble in this population. It requires specialized support and psychosocial program. Narrative Exposure Therapy (NET), a german psychotherapy, was developed in the 2000 to specifically treat psycho-trauma in this population. It is brief, effective on complex trauma and can be delivered by trained non-caregivers. All published randomized studies have conclued that NET is effetive, but there are still insifficient numbers to make recomendations. To our knowledge, NET has never been tested in France. In Marseille, SINDIANE is a community support and program for refugees and asylum seekers. Many workshops led by peer workers are offered to increase empowerment of beneficiaries and hel them to recover. The development of a NET workshop would make it possible to combine community support and specific and validated psychotherapy. Through this study, the investigators hypothesize that tratment of PTSD with NET in the community-based SINDIANE program decrease symptoms of PTSD.
Detailed description
Methods and design Forty-six participants with a diagnosis of PTSD disorder within the SINDIANE program will be recruited. A prospective single-blind randomized clinical trial will be conducted comparing two groups, one participant in the classic SINDIANE program and one being treated in addition by NET workshp. The evaluations will be done at the baseline, after the intervention and at three and six months follow-up. IN addition, the qualitative and participatory research method called photovoice will be used to better understand the experiences of participants who recieve NETtroughout their recovery.
The primary objective is the assessment of the symptom intensity score (PCL-5) of posttraumatic stress disorder (PTSD).
Secondary objectives are represented by:
- The assessment of the stability over time of the PTSD symptom intensity score at three months and six months (PCL-5).
- Assessment of the intensity of global psychiatric comorbidities (RHS-15)
- Evaluation of life indicators: ability to act, quality of life (GSE self-efficacy questionnaire).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Psychotherapy using Narrative Exposure Therapy (NET)Beneficiaries of NET therapy + standard Sindiane program management. |
| Control group | No intervention | –Beneficiaries of the standard care of the Sindiane program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Woman over 18
- Refugee or asylum seeker (habing applied to OFFPRA or with a residence permit)
- Belonging to the SINDIANE community project
- Having been exposed to at least one traumatic event (according to the DSM 5 definition validated by a doctor)
- Having a PCL5 score greater than 23
Key exclusion criteria (8 listed)
- Be under the age of 18
- Be included in another intervention research
- Presence of severe mental retardation or dementia according to DSM5
- Persons benefiting from special protection : under article L3212-1 and L3213-1 of the Public Health Code
- Persons referred to in articles L1121-5 to L1121-8 of the CSP
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 |
|---|---|---|
| Psychotherapy using Narrative Exposure Therapy (NET)There are four NET sessions, each lasting thirty minutes and defined in advance on a weekly basis. The first session is the one where the person concerned will establish his/her "Life Line" and start his/her life story with the peer mediator. The second and third session will be the one where the person will continue his life story. Each session will begin with the mediator reading the story from the previous session, with the person concerned modifying the story if they wish. The fourth session will also start with the reading of the story from the previous session and will finish the story if necessary. It will also be the occasion to give the printed story to the person concerned at the end of the session and have it signed by the mediator and the patient. To prevent a possible risk of decompensation of the subject during the session, there will be a psychiatrist on site at the time of the NET to be available if the patient needs it. | Behavioural | Experimental group |
Primary outcome
PTSD symptoms measure by PCL5
Time frame: 1 month post NET therapy
The PCL-5 is a self reported score. The higher the score, the greater intensity of the symptoms of PTSD. It is validated in english and french with goof psychometric characteristic. The total score of the questionnaire is 80. The scale varies per question from 0 to 4: 0 = Not at all 1. = A little bit 2. = Moderately 3. = Quite a bit 4. = Extremely If the patient gets a 0, it means that he/she does not have this symptom of post-traumatic stress. On the contrary, the more the score increases and tends towards 4, the more the symptom will be present in the patient.
3 secondary outcomes
Evolution of PCL5 score
Time frame: 3 months and 6 months
Psychiatric comorbidity intensity score RHS15
Time frame: before the intervention, 1 month post therapy, 3 months and 6 months
EvExperience indicators intensity score (GSE)
Time frame: before the intervention, 1 month post therapy, 3 months and 6 months
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 9 Aug 2024.
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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.
François CREMIEUX study director
Assistance Publique Hôpitaux Marseille
Clotilde IZABELLE, Dr principal investigator
Assistance Publique Hôpitaux Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy using Narrative Exposure Therapy (NET) in people with Post-traumatic Stress Disorder (PTSD), run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 8 inclusion and 8 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 9 Aug 2024. 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 France. 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?
PTSD symptoms measure by PCL5 (time frame: 1 month post NET therapy). 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 9 Aug 2024.