跳至主要内容
临床试验/NCT06464432
NCT06464432招募中不适用

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

University of Lausanne2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Acceptability ESTAIR Manual

研究概览

简要总结

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.

详细描述

For further information, please see the attached protocol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Acceptability ESTAIR Manual

时间窗: 7 months

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

Feasibility of ITI-Cultural Module

时间窗: 7 months

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.

Acceptability of ITI-Cultural Module

时间窗: 7 months

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

Feasibility ESTAIR Manual

时间窗: 7 months

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.

次要结局

  • Depression(7 months)
  • Somatic Symptoms(7 months)
  • Complex post-traumatic stress disorder(7 months)
  • Anxiety(7 months)
  • Well-being(7 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadine Hosny

Doctoral Assistant, PhD Candidate

University of Lausanne

研究点 (2)

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