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

Post-traumatic Stress Disorder (PTSD) Clinical Trial

— SINDIANE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407337
• Other study ID #: 2021-A01172-39
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: February 15, 2025

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Clotilde IZABELLE, Dr
• Phone: 0660536125
• Email: clotilde.izabelle[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: February 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux Marseille	Marseille	Bouches-du-Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month post NET therapy
Secondary	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.	3 months and 6 months
Secondary	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.	before the intervention, 1 month post therapy, 3 months and 6 months
Secondary	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.	before the intervention, 1 month post therapy, 3 months and 6 months