- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05785312
Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan
March 24, 2023 updated by: Dr. Anwar Khan, Khushal Khan Khattak Univeristy, Karak, Pakistan
Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study*
This study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan.
Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Depressive and Anxiety disorders have higher global prevalence.
Moreover, they are leading causes of global burden of mental diseases (i.e., 24th leading cause of global Disability-adjusted Life Years).
Such increase in the global prevalence of Depression and Anxiety disorders is due to the complexities of modern life.
Nowadays various evidence-based psychotherapies, like e.g., EMDR therapy are available.
Therapists have been using face-to-face modes for a long time, but with the expansion of Computer Technologies, online psychotherapies have been developed.
The need for online psychotherapies was further increased due to Corona Virus-19 pandemic.
Scientists have developed online modes of Cognitive Behavioral Therapy, Prolonged Exposure Therapy and Mindfulness Therapy, etc., but there are limited research studies on the online EMDR therapy, especially in the Asian countries.
Therefore, questions arises a) Is it possible to treat Anxiety & Depressive disorders through online EMDR therapy?
b) What adaptations would be required to be made in the face-to-face protocols of EMDR therapy?
c) Whether the online EMDR therapy will be: i) fit and safe for use; ii) usable; iii) operable & practicable; and iv) efficient in delivering a timely treatment?
The existing online programs of EMDR Therapy, e.g., VirtualEMDR have been built in the western-developed countries, hence may not be accessible to the local patients in Pakistan.
Moreover, these programs might not be compatible with the requirements of patients in Pakistan.
Keeping in view such facts, this study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan.
Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.
For this purpose, patients will be recruited through a consecutive sampling technique, with a sample size of n=30.
Data on symptomology and other technical data will be collected through standard scales.
Qualitative data were analyzed by qualitative techniques, while the quantitative data were analyzed by descriptive and multivariate statistics.
This study will be unique in its nature since a) an online EMDR therapy will be developed for Pakistani patients, b) this online system will be scientifically validated, c) and its efficacy will be compared with face-to-face EMDR therapy.
This study will provide a base for the future researchers to design and implement online psychotherapies in Pakistan.
In this way, the mental healthcare system of Pakistan could be ultimately revolutionized through the online treatment facilities.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
Pakistan
-
Khyber Pakhtunkhwa
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Lakki Marwat, Khyber Pakhtunkhwa, Pakistan, 28420
- Kushal Khan University
-
Contact:
- Anwar Khan, PhD
- Phone Number: +92334560433
- Email: [email protected]
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both male and female patients.
- Patients between the age of 18 to 50 years (since this study is neither on children nor on old patients).
- Patients who have basic knowledge & skills of computer, mobile and internet (although the recruited patients will be given training for using the online EMDR).
- Patients do not suffer from severe neuropsychological and cognitive impairments.
- Patients have not received any pharmacological therapy in the last three months.
- Patients have not received any other psychotherapy like Cognitive Behavioral Therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Face to Face Eye Movement Desensitization & Reprocessing Therapy
The standard Face to Face Eye Movement Desensitization & Reprocessing Therapy will be applied by a trained clinical psychologist through in person face to face sessions.
|
The Face to Face Eye Movement Desensitization & Reprocessing Therapy will be delivered in person inside clinician's room by following standard EMDR therapy protocol
|
Active Comparator: Online Eye Movement Desensitization & Reprocessing Therapy
The Online Eye Movement Desensitization & Reprocessing Therapy will be applied by a trained clinical psychologist through computer system by connecting through internet.
For this purpose the online EMDR therapy application software will be installed
|
Online EMDR Therapy System will be delivered through online computer system that will be specifically designed for delivering EMDR therapy online
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)
Time Frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Generalized Anxiety Disorder by Generalized Anxiety Disorder Questionnaire-IV.
Score of 5.7 or above will indicate that the patient is suffering from Generalized Anxiety Disorder.
|
A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Assessing changes in symptom of Major Depressive Disorder with time (i.e., treatment course)
Time Frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Major Depressive Disorder by Beck Depression Inventory-II.
Score of 30 or above will indicate that the patient is suffering from major depressive disorder
|
A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Assessing changes in symptom of Social Anxiety Disorder with time (i.e., treatment course)
Time Frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Social Anxiety Disorder will be assed by Social Anxiety Scale.
Score of 60 or above will indicate that the patient is suffering from Social Anxiety Disorder.
|
A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing changes in Panic symptoms with time (i.e., treatment course)
Time Frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Panic Attacks by Panic Disorder Severity Scale.
Score of 20 or above will indicate that the patient is suffering form panic symptoms.
|
A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Assessing changes in Somatic symptoms
Time Frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Somatic Symptoms by the Somatic Symptom Scale-8.
Score of 11 or above will indicate that the patient is suffering from somatic symptoms.
|
A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Assessing changes in Obsessive symptoms with time (i.e., treatment course)
Time Frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Obsessive Compulsive Symptoms by Dimensional Obsessive-Compulsive Scale.
Score of 15 or above on each dimension will indicate that the patient is having Obsessive Compulsive Symptoms.
|
A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2023
Primary Completion (Anticipated)
July 1, 2025
Study Completion (Anticipated)
August 1, 2025
Study Registration Dates
First Submitted
February 1, 2023
First Submitted That Met QC Criteria
March 24, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12321
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
will only be shared after placing valid request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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