The Effect of Narrative Exposure Therapy Intervention on Post-traumatic Stress Dissorder and Personal Recovery in Refugees and Asylum Seekers of Sindiane Programme

NCT ID: NCT05407337

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2024-04-23

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).

Conditions

Post-traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Beneficiaries of NET therapy + standard Sindiane program management.

Group Type: EXPERIMENTAL

Psychotherapy using Narrative Exposure Therapy (NET)

Intervention Type: BEHAVIORAL

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.

Control group

Beneficiaries of the standard care of the Sindiane program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux Marseille

Clotilde IZABELLE, Dr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hôpitaux Marseille

Locations

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-Rhône, France

Countries

France

Other Identifiers

2021-A01172-39

Identifier Type: -

Identifier Source: org_study_id