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临床试验/NCT06439043
NCT06439043招募中不适用

Developing a Culturally and Methodologically Adapted EMDR Protocol for the Treatment of Major Depressive Disorder and Determining Its Efficacy by Testing it Through Online and Face-to-face Modes of EMDR Therapy

Khushal Khan Khattak Univeristy, Karak, Pakistan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Major Depressive Disorder

研究概览

简要总结

The present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, determine its treatment fidelity, and then clinically test its efficacy in the treatment of Major Depressive Disorder in Pakistan by utilizing both in-person and online modalities of EMDR therapy.

详细描述

Background and Aim: Major Depressive Disorder(MDD) is a globally leading cause of disability. Currently, psychotherapies like Eye Movement Desensitization and Reprocessing(EMDR) and Cognitive Behavioral Therapy(CBT) are widely available. Since EMDR originated in the United States, it may not be completely appropriate for non-Western countries like Pakistan, necessitating possible modifications. Moreover, therapists have long practiced face-to-face EMDR, but recently, online EMDR modalities have emerged. Nonetheless, it is surprising that there is a dearth of research not only on adaptations of EMDR in Pakistan but also on testing its clinical efficacy, particularly its online modalities. Considering this, the present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, and clinically evaluate its efficacy in treating MDD in Pakistan by comparatively administering it through in-person and online modalities. Methods: This study will employ a mixed mode Randomized Controlled Trial design with a consecutive sample of (n=90). Patients will be treated by using adapted EMDR therapy protocol. Patients will be randomly allocated to in-person and online modes of EMDR. Various qualitative methods and quantitative techniques will be employed to data. Conclusion: This study is likely to make significant contributions by delivering insights about how to develop culturally and methodologically adapted EMDR. This study will extend our knowledge about the comparative effectiveness of EMDR in Pakistan.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

It will be a single-blinded study in which only the participants will be unaware of certain aspects of the research design. Typically, this means that the participants will not know which treatment they are receiving or the mode of treatment (online or face-to-face), while the researchers administering the treatment and collecting data will be aware.

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The patient should exhibit symptoms of Major Depressive Disorder.
  • •Male and female patients will be chosen equally.
  • •Patients between the ages of 20 and 50 will be selected.
  • •Patients should preferable be "treatment-naïve," meaning they have no recent history of any psychotherapy or medication.

排除标准

  • •a. There must be no significant neuropsychological or cognitive disorders among the patients

研究组 & 干预措施

Face to Face Eye Movement Desensitization & Reprocessing Therapy

Experimental

The face-to-face Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered by the psychotherapist at their clinic. The treatment will consist of a total of 12 to 13 sessions, with one session conducted per week.

干预措施: EMDR Psychotherapy (Other)

Online Eye Movement Desensitization and Reprocessing therapy

Active Comparator

The online Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered by the psychotherapist using BilateralBase software. The treatment will consist of 12 to 13 online sessions, with one session conducted per week.

干预措施: Online EMDR Psychotherapy (Other)

结局指标

主要结局

Major Depressive Disorder

时间窗: 6 months

Major Depressive Disorder will be assess by Hamilton Depression rating scale with score more than 30 as cut off point

次要结局

未报告次要终点

研究者

发起方
Khushal Khan Khattak Univeristy, Karak, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Anwar Khan

PhD Student

University Malaysia Sarawak

研究点 (1)

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