Clinical trial NCT05407337: The Effect of Narrative Exposure Therapy Intervention on Post-traumatic Stress Dissorder and Personal Recovery in Refugees and Asylum Seekers of Sindiane Programme
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PTSD symptoms measure by PCL5
timeFrame: 1 month post NET therapy
Secondary outcomes:
measure: Evolution of PCL5 score
timeFrame: 3 months and 6 months
measure: Psychiatric comorbidity intensity score RHS15
timeFrame: before the intervention, 1 month post therapy, 3 months and 6 months
measure: EvExperience indicators intensity score (GSE)
timeFrame: before the intervention, 1 month post therapy, 3 months and 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux Marseille
state: Bouches-du-Rhône
Study officials:
affiliation: Assistance Publique Hôpitaux Marseille
name: François CREMIEUX
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hôpitaux Marseille
name: Clotilde IZABELLE, Dr
role: PRINCIPAL_INVESTIGATOR
References: