Cultural Adaptation of EMDR for Major Depressive Disorder and Compaire Its Online and Face-to-Face Testing

NCT ID: NCT06439043

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Face to Face Eye Movement Desensitization & Reprocessing Therapy

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.

Group Type EXPERIMENTAL

EMDR Psychotherapy

Intervention Type OTHER

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

Online Eye Movement Desensitization and Reprocessing therapy

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.

Group Type ACTIVE_COMPARATOR

Online EMDR Psychotherapy

Intervention Type OTHER

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

Interventions

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EMDR Psychotherapy

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khushal Khan Khattak Univeristy, Karak, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Anwar Khan

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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KKKUk

Kohat, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Facility Contacts

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Anwar Khan

Role: primary

03245603231 ext. 232

Other Identifiers

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1213

Identifier Type: -

Identifier Source: org_study_id

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