Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05407337
Study type Interventional
Source Assistance Publique Hopitaux De Marseille
Contact Clotilde IZABELLE, Dr
Phone 0660536125
Email clotilde.izabelle@ap-hm.fr
Status Recruiting
Phase N/A
Start date November 22, 2022
Completion date February 15, 2025

See also
  Status Clinical Trial Phase
Terminated NCT05189977 - A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline Phase 1
Completed NCT01806168 - rTMS in the Treatment of PTSD N/A
Not yet recruiting NCT06194851 - Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD Phase 2
Completed NCT02187224 - Progesterone Effect on Individuals Diagnoses With AD and PTSD. Phase 2/Phase 3
Completed NCT02549508 - Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD N/A
Not yet recruiting NCT01940549 - Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy for Posttraumatic Stress Disorder N/A
Completed NCT02012738 - Treatment of Trauma and Violence in the Townships of South Africa N/A
Not yet recruiting NCT06419959 - NightWare and Cardiovascular Health in Veterans With PTSD N/A
Terminated NCT03209882 - Transcranial Infrared Laser Stimulation (TILS) of Prefrontal Cognition in Post-traumatic Stress Disorder (PTSD) N/A
Completed NCT04891614 - The PRISM Pilot Trial for Post-Traumatic Stress Disorder N/A
Completed NCT02030522 - Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma N/A
Completed NCT01729325 - Prevention of Post-Traumatic Stress Disorder in Soldiers Phase 2
Completed NCT02053532 - Functional Brain Imaging in PTSD N/A
Not yet recruiting NCT02598024 - Treating Earthquake in Nepal Trauma (TENT) Trial 2016 N/A
Terminated NCT02237703 - Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD) N/A
Withdrawn NCT02356861 - LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans N/A
Not yet recruiting NCT05974631 - Evaluating Treatments for Suicidal Veterans With PTSD N/A
Not yet recruiting NCT06288594 - TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability N/A
Completed NCT01847469 - Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence Phase 2
Terminated NCT02237677 - CB1 Receptor PET Imaging Reveals Gender Differences in PTSD N/A