Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT07015567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland
Sponsor:
Eva Heim
Organization:
Study Overview
Official Title:
Contextualised, Culture-sensitive Diagnosis and Psychotherapy for the Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland: A Two-step Multicentric Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTAIR_REFUGEE
Brief Summary:
In WHO ICD-11 (its latest edition), the diagnostic criteria for post-traumatic stress disorder (PTSD) were revised, and a new sibling disorder, complex post-traumatic stress disorder (CPTSD) was introduced. CPTSD is a debilitating condition associated with severe, prolonged, or chronic trauma. Refugee populations are affected by high prevalence of CPTSD because of high rates of such trauma (e.g. torture). Untreated CPTSD has negative consequences for quality of life and for integration into the host society. Evidence indicates cultural variation in the phenomenology of CPTSD.
Modular approaches, e.g., the Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE), have been recommended for the treatment of CPTSD. However, they have not been tested in a clinical trial among refugees so far and there are no available publications about their effectiveness in CPTSD symptom reduction among this population. Research suggests a higher symptom reduction of trauma-focused techniques, such as Narrative Exposure Therapy (NET), among refugee population. In a previous study, we pilot tested a version of ESTAIR/NET that was adapted to sociocultural and structural aspects related to psychopathology in refugee populations. The performance of these culturally adapted modules in CPTSD symptom reduction among the refugee population remains to be assessed.
The present clinical trial seeks to assess the effect of the culturally adapted modules of the ESTAIR manual on symptom reduction among refugees and asylum seekers diagnosed with CPTSD.
Modular approaches, e.g., the Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE), have been recommended for the treatment of CPTSD. However, they have not been tested in a clinical trial among refugees so far and there are no available publications about their effectiveness in CPTSD symptom reduction among this population. Research suggests a higher symptom reduction of trauma-focused techniques, such as Narrative Exposure Therapy (NET), among refugee population. In a previous study, we pilot tested a version of ESTAIR/NET that was adapted to sociocultural and structural aspects related to psychopathology in refugee populations. The performance of these culturally adapted modules in CPTSD symptom reduction among the refugee population remains to be assessed.
The present clinical trial seeks to assess the effect of the culturally adapted modules of the ESTAIR manual on symptom reduction among refugees and asylum seekers diagnosed with CPTSD.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10001G_212438 | OTHER_GRANT | Swiss National Science Foundation | View |