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

NCT06439043 | Recruiting

• 1 other identifier: 1213
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder 1

Keywords

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: EMDR Psychotherapy

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.

Other: Online EMDR Psychotherapy

Interventions

EMDR Psychotherapy OTHER

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

Face to Face Eye Movement Desensitization & Reprocessing Therapy

Online EMDR Psychotherapy OTHER

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

Online Eye Movement Desensitization and Reprocessing therapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: both male and female patients will be selected
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Khushal Khan Khattak Univeristy, Karak, Pakistan: lead

Study Sites (1)

KKKUk

Kohat, 27200, Pakistan

RECRUITING

MeSH Terms

Conditions

Major Depressive Disorder 1; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: January 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

PA (1)