Developing an Adapted EMDR Therapy for Major Depressive Disorder and Assessing its Efficacy through Online and Face-to-Face Modalities: A Protocol for Mixed Method Randomized Controlled Trial (Preprint)

Abstract

Major Depressive Disorder (MDD) is a psychiatric condition that globally ranks as the 24th leading cause of Disability-adjusted Life Years. Pakistan, a developing nation, grapples with poverty, resource inequality, population growth, and political instability, which may probable cause MDD among general population. Resultantly high prevalence of MDD in Pakistan in evident from the existing literature. Currently, evidence-based psychotherapies such as Eye Movement Desensitization and Reprocessing(EMDR) are widely available. However, EMDR originated in the United States, it might not be consistent with requirements of non-western countries, so it may require cross-cultural and methodological adaptations. 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 on both the adaptations of EMDR in Pakistan and its clinical efficacy, particularly its online modes have never been scientifically validated in Pakistan.

Considering lack of research on adaptations and clinical efficacy EMDR in Pakistan, the present study aims to develop a culturally and methodologically adapted EMDR therapy protocol for MDD in Pakistan, determine its treatment fidelity, and then clinically test its efficacy by administering it through the face-to-face and online modalities of EMDR therapy.

This study adopted a mixed-mode exploratory sequential Randomized Controlled Trial design in two phases. In the first phase, qualitative exploratory data will be collected, followed by quantitative data, to accomplish the adaptation process of the EMDR therapy protocol. In the second phase, a consecutive sample of 80 patients will be randomly allocated in a 1:1 ratio to face-to-face and online groups to determine the clinical efficacy of the adapted EMDR therapy protocol in both modalities. Symptoms related data will be collected through clinician administered scales during start, mid, end and follow-up stages of therapy. Data will be analyzed using a variety of qualitative and quantitative statistical techniques.

This study has been approved by the Ethics Review Committees of Khushal Khan Khattak University Karak, Pakistan, and University Malaysia Sarawak, Malaysia. It is registered at ClinicalTrials.gov. The process of adapting the DeprEnd-EMDR Depression Protocol has already begun. Recruitment of patients for psychotherapy sessions will start in September 2024.

In conclusion, this study addresses significant research gaps concerning the adaptation and clinical efficacy of EMDR therapy in the Asian region, with a particular focus on its online modalities. By employing a rigorous research methodology, the results are likely to make substantial contributions by providing insights into both the adaptation and clinical efficacy of EMDR therapy. This study will extend our understanding of the comparative effectiveness of EMDR therapy in the Asian region, offering valuable information on its applicability and impact in diverse, particularly non-Western, settings.

ClinicalTrials.gov ID NCT06439043