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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06439043
Other study ID # 1213
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date September 30, 2025

Study information

Verified date May 2024
Source Khushal Khan Khattak Univeristy, Karak, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date September 30, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility 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

Study Design


Intervention

Other:
EMDR Psychotherapy
EMDR psychotherapy will be delivered in person by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions.
Online EMDR Psychotherapy
Online EMDR Psychotherapy will be delivered online by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Khushal Khan Khattak Univeristy, Karak, Pakistan

Outcome

Type Measure Description Time frame Safety issue
Primary Major Depressive Disorder Major Depressive Disorder will be assess by Hamilton Depression rating scale with score more than 30 as cut off point 6 months
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