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

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: Generalized Anxiety Disorder; Major Depressive Disorder; Social Anxiety Disorder; Panic Attacks; Somatic Symptom; Obsessive-Compulsive Disorder and Symptoms
• Intervention / Treatment: Other: Face to Face Eye Movement Desensitization & Reprocessing Therapy; Device: Online EMDR Therapy System

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

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Lakki Marwat, Khyber Pakhtunkhwa, Pakistan, 28420
      • Kushal Khan University
      • Contact: Anwar Khan, PhD; Phone Number: +92334560433; Email: akpashtoon1981@gmail.com

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	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
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	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

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)	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)	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)	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)	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	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)	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

• Sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan

Study record dates

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: Depression; Anxiety; Pakistan; Pilot Study; EMDR; Online EMDR
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Phobic Disorders; Depression; Depressive Disorder; Disease; Obsessive-Compulsive Disorder; Anxiety Disorders; Depressive Disorder, Major; Phobia, Social; Panic Disorder; Medically Unexplained Symptoms
• 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