Clinical trial NCT06439043: Cultural Adaptation of EMDR for Major Depressive Disorder and Compaire Its Online and Face-to-Face Testing
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder 1
Keywords: Depressive Disorder, Major
Lead sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The adapted EMDR treatment protocol will be administered both online and face-to-face. Patients will be randomly allocated to either the face-to-face mode or the online mode of EMDR at the same time.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Major Depressive Disorder
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kohat
country: Pakistan
facility: KKKUk
Study officials:
References: