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

Primary Purpose

Post-traumatic Stress Disorder (PTSD)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychotherapy using Narrative Exposure Therapy (NET)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-traumatic Stress Disorder (PTSD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hôpitaux MarseilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Beneficiaries of NET therapy + standard Sindiane program management.

Beneficiaries of the standard care of the Sindiane program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 23, 2022
Last Updated
July 25, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05407337
Brief Title
The Effect of Narrative Exposure Therapy Intervention on Post-traumatic Stress Dissorder and Personal Recovery in Refugees and Asylum Seekers of Sindiane Programme
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Beneficiaries of NET therapy + standard Sindiane program management.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Beneficiaries of the standard care of the Sindiane program.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy using Narrative Exposure Therapy (NET)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD symptoms measure by PCL5
Description
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.
Time Frame
1 month post NET therapy
Secondary Outcome Measure Information:
Title
Evolution of PCL5 score
Description
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.
Time Frame
3 months and 6 months
Title
Psychiatric comorbidity intensity score RHS15
Description
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.
Time Frame
before the intervention, 1 month post therapy, 3 months and 6 months
Title
EvExperience indicators intensity score (GSE)
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Refugee women aged 18 and over and asylum seekers in the SINDIANE program
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clotilde IZABELLE, Dr
Phone
0660536125
Email
clotilde.izabelle@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
Assistance Publique Hôpitaux Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Clotilde IZABELLE, Dr
Organizational Affiliation
Assistance Publique Hôpitaux Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux Marseille
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjorie Saccone
Email
marjorie.saccone@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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

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