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

NCT06464432 | Recruiting

• 2 other identifiers: 052024_000012023-2024-204
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• Feasibility ESTAIR Manual

  We will primarily assess feasibility by determining the percentage of participants who complete the study until the end (among those who sign the informed consent). Based on reported dropout rates from studies using similar modular interventions with trauma survivors, we will consider 80-90% participation and adherence as excellent, 70-80% as satisfactory, and 60-70% as acceptable.

  7 months

• Acceptability ESTAIR Manual

  We will assess the acceptability by conducting feedback qualitative interviews after each module and overall feedback on therapy process at the end of therapy.

  7 months

• Feasibility of ITI-Cultural Module

  We will assess the ITI feasibility, using the same method based on the percentage of participants who complete the ITI; 80-90% participation and adherence is considered as excellent, 70-80% as satisfactory, and 60-70% as acceptable.

  7 months

• Acceptability of ITI-Cultural Module

  We will assess the acceptability of the ITI through qualitative interviews after the diagnostic interview.

  7 months

Secondary Outcomes (5)

• Complex post-traumatic stress disorder

  7 months

• Depression

  7 months

• Anxiety

  7 months

• Somatic Symptoms

  7 months

• Well-being

  7 months

Study Arms (1)

Intervention: ESTAIR Psychotherapeutic Manual

EXPERIMENTAL

Behavioral: Enhanced Skills Training in Affective and Interpersonal Regulation

Interventions

Enhanced Skills Training in Affective and Interpersonal Regulation 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.

Intervention: ESTAIR Psychotherapeutic Manual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Egyptian
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Lausanne: lead
• The American University in Cairo: collaborator

Study Sites (1)

The American University in Cairo

Cairo, 11835, Egypt

RECRUITING

Central Study Contacts

Nadine Hosny, MSc

CONTACT

+41766380067; nadine.hosny@unil.ch

Eva Heim, PhD

CONTACT

+41 21 692 31 75; eva.heim@unil.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Assistant, PhD Candidate

Model Details: Un-randomized Pilot

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: August 1, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 1, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

EG (1)