Major Depressive Disorder 1EMDRNCT06439043
Cultural Adaptation of EMDR for Major Depressive Disorder and Compaire Its Online and Face-to-Face Testing
A study testing EMDR Psychotherapy and Online EMDR Psychotherapy in people with Major Depressive Disorder 1, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder 1
- What is being tested?
- EMDR Psychotherapy and Online EMDR Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- There must be no significant neuropsychological or cognitive disorders among the patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
KKKUk
Kohat, 27200
Anwar Khan, 03245603231 ext. 232, akpashtoon1981@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder 1
- Being tested
- EMDR Psychotherapy, Online EMDR Psychotherapy
- Keywords
- Depressive Disorder, Major
- Medical subject headings
- Major Depressive Disorder 1, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR PsychotherapyOther
EMDR psychotherapy will be delivered in person by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions.
Online EMDR PsychotherapyOther
Online EMDR Psychotherapy will be delivered online by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Online EMDR Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Depressive Disorder
Major Depressive Disorder will be assess by Hamilton Depression rating scale with score more than 30 as cut off point
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jan 2025
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anwar Khan, University Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439043
- Sponsor's protocol ID
- 1213
- Acronym
- EMDR
- Status last verified
- Jan 2025
- First submitted
- 27 May 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06439043
- Acronym / sponsor ID
- EMDR / 1213
- Conditions
- Major Depressive Disorder 1
- Keywords
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Face to Face Eye Movement Desensitization & Reprocessing Therapy | Experimental | Other: EMDR PsychotherapyThe 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. |
| Online Eye Movement Desensitization and Reprocessing therapy | Active comparator | Other: Online EMDR PsychotherapyThe 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- There must be no significant neuropsychological or cognitive disorders among the patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR PsychotherapyEMDR psychotherapy will be delivered in person by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions. | Other | Face to Face Eye Movement Desensitization & Reprocessing Therapy |
| Online EMDR PsychotherapyOnline EMDR Psychotherapy will be delivered online by the psychotherapist to treat symptoms of Major Depressive Disorder, consisting of 12 weekly sessions. | Other | Online Eye Movement Desensitization and Reprocessing therapy |
Primary outcome
Major Depressive Disorder
Time frame: 6 months
Major Depressive Disorder will be assess by Hamilton Depression rating scale with score more than 30 as cut off point
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR Psychotherapy and Online EMDR Psychotherapy in people with Major Depressive Disorder 1, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Depressive Disorder (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.