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

Major Depressive Disorder Clinical Trial

Official title:

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*

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05785312
• Other study ID #: 12321
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2023
• Source: Khushal Khan Khattak Univeristy, Karak, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 50 Years

Eligibility

Inclusion Criteria:

1. Both male and female patients.

2. Patients between the age of 18 to 50 years (since this study is neither on children nor on old patients).

3. Patients who have basic knowledge & skills of computer, mobile and internet (although the recruited patients will be given training for using the online EMDR).

4. Patients do not suffer from severe neuropsychological and cognitive impairments.

5. Patients have not received any pharmacological therapy in the last three months.

6. Patients have not received any other psychotherapy like Cognitive Behavioral Therapy.

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Medically Unexplained Symptoms
• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder and Symptoms
• Panic Attacks
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder
• Somatic Symptom

Intervention

Device:
• Online EMDR Therapy System
Online EMDR Therapy System will be delivered through online computer system that will be specifically designed for delivering EMDR therapy online

Other:
• Face to Face Eye Movement Desensitization & Reprocessing Therapy
The Face to Face Eye Movement Desensitization & Reprocessing Therapy will be delivered in person inside clinician's room by following standard EMDR therapy protocol

Locations

Country	Name	City	State
Pakistan	Kushal Khan University	Lakki Marwat	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Khushal Khan Khattak Univeristy, Karak, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)	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)
Primary	Assessing changes in symptom of Major Depressive Disorder with time (i.e., treatment course)	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)
Primary	Assessing changes in symptom of Social Anxiety Disorder with time (i.e., treatment course)	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	Assessing changes in Panic symptoms with time (i.e., treatment course)	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)
Secondary	Assessing changes in Somatic symptoms	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)
Secondary	Assessing changes in Obsessive symptoms with time (i.e., treatment course)	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)