Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic

NCT ID: NCT06464432

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-03-01

Brief Summary

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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

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For further information, please see the attached protocol.

Conditions

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Complex Post-Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Un-randomized Pilot
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention: ESTAIR Psychotherapeutic Manual

Group Type EXPERIMENTAL

Enhanced Skills Training in Affective and Interpersonal Regulation

Intervention Type BEHAVIORAL

Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR); Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD) consisting of 4 therapeutic modules: 1. Emotion Regulation, 2, Self-concept, 3. Relationship Patterns, 4. Prolonged Exposure.

Interventions

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Enhanced Skills Training in Affective and Interpersonal Regulation

Enhanced Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR); Psychotherapeutic manual for the treatment of Complex Post-Traumatic Stress Disorder (CPTSD) consisting of 4 therapeutic modules: 1. Emotion Regulation, 2, Self-concept, 3. Relationship Patterns, 4. Prolonged Exposure.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The American University in Cairo

OTHER

Sponsor Role collaborator

University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Nadine Hosny

Doctoral Assistant, PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The American University in Cairo

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nadine Hosny, MSc

Role: CONTACT

+41766380067

Eva Heim, PhD

Role: CONTACT

+41 21 692 31 75

Facility Contacts

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Nadine Hosny, MSc

Role: primary

+201005557273

Kate Ellis, PhD

Role: backup

0020 2615 1817

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2023-2024-204

Identifier Type: OTHER

Identifier Source: secondary_id

052024_00001

Identifier Type: -

Identifier Source: org_study_id

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