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

NCT05407337 | Completed

• 1 other identifier: 2021-A01172-39
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month post NET therapy

Secondary Outcomes (3)

• Evolution of PCL5 score

  3 months and 6 months

• Psychiatric comorbidity intensity score RHS15

  before the intervention, 1 month post therapy, 3 months and 6 months

• EvExperience indicators intensity score (GSE)

  before the intervention, 1 month post therapy, 3 months and 6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Beneficiaries of NET therapy + standard Sindiane program management.

Behavioral: Psychotherapy using Narrative Exposure Therapy (NET)

Control group

NO INTERVENTION

Beneficiaries of the standard care of the Sindiane program.

Interventions

Psychotherapy using Narrative Exposure Therapy (NET) 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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Refugee women aged 18 and over and asylum seekers in the SINDIANE program
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-Rhône, 13354, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• François CREMIEUX

  Assistance Publique Hôpitaux Marseille

  STUDY DIRECTOR

• Clotilde IZABELLE, Dr

  Assistance Publique Hôpitaux Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 7, 2022
• Study Start: November 22, 2022
• Primary Completion: October 23, 2023
• Study Completion: April 23, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

FR (1)