An interventional study of Psychotherapy using Narrative Exposure Therapy (NET) in Post-traumatic Stress Disorder (PTSD), sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Other
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.
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:
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Beneficiaries of NET therapy + standard Sindiane program management.
Behavioral: Psychotherapy using Narrative Exposure Therapy (NET)
Beneficiaries of the standard care of the Sindiane program.
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.
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 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.
Time frame: 1 month post NET therapy
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 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.
Time frame: 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 1. = A little bit 2. = Moderately 3. = Quite a bit 4. = 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.
Time frame: 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.
Time frame: before the intervention, 1 month post therapy, 3 months and 6 months
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique Hopitaux De Marseille