Clinical trial NCT06464432: Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic
Official title: Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: The American University in Cairo
First posted: 2024-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Un-randomized Pilot
Primary purpose: TREATMENT

Brief summary: Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such diagnoses and therapeutic interventions. Along with cultural aspects, there are relevant structural aspects e.g., economic, and social inequalities, which impact mental health. These aspects remain understudied in low middle income countries like Egypt, where there are considerable rates of violence.

Aims: The project aims to i) culturally adapt and pilot test the therapeutic manual ESTAIR/MPE in urban Egypt, and ii) to pilot test a cultural and structural module for the diagnostic assessment of CPTSD among the same target population. The objective is to assess the feasibility, acceptability, and initial impact on clinical outcomes of both the manual and diagnostic modules.

Methods: In earlier phases, the project gathered qualitative data from key informants on the cultural and structural dimensions of CPTSD in urban Egypt. Using the collected data, investigators culturally adapted this intervention and developed a diagnostic cultural module. Subsequently, the investigators will pilot-test it in four groups of five participants each, 20 participants in total. The project intends to collect both quantitative and qualitative measures to explore determined outcomes and analyze them accordingly.

Detailed description: For further information, please see the attached protocol.

Eligibility criteria: Inclusion Criteria:

* Egyptian
* 18 years of age or older
* Literate, can give written or oral consent
* History of severe and/or prolonged trauma, and screen positive for CPTSD
* Reside in any other major city

Exclusion Criteria:

* Imminent risk of suicide, psychotic symptoms, and/or severe alcohol and/or drug abuse
* Have been in therapy before (i.e., completed more than 5-10 sessions of psychotherapy)

Primary outcomes:
measure: Feasibility ESTAIR Manual
timeFrame: 7 months
measure: Acceptability ESTAIR Manual
timeFrame: 7 months
measure: Feasibility of ITI-Cultural Module
timeFrame: 7 months
measure: Acceptability of ITI-Cultural Module
timeFrame: 7 months
Secondary outcomes:
measure: Complex post-traumatic stress disorder
timeFrame: 7 months
measure: Depression
timeFrame: 7 months
measure: Anxiety
timeFrame: 7 months
measure: Somatic Symptoms
timeFrame: 7 months
measure: Well-being
timeFrame: 7 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The American University in Cairo
Study officials:
References: