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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

Primary Purpose

Generalized Anxiety Disorder, Major Depressive Disorder, Social Anxiety Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Online EMDR Therapy System
Face to Face Eye Movement Desensitization & Reprocessing Therapy
Sponsored by
Khushal Khan Khattak Univeristy, Karak, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring EMDR, Online EMDR, Depression, Anxiety, Pakistan, Pilot Study

Eligibility Criteria

18 Months - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kushal Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Face to Face Eye Movement Desensitization & Reprocessing Therapy

Online Eye Movement Desensitization & Reprocessing Therapy

Arm Description

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 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

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 1, 2023
Last Updated
March 24, 2023
Sponsor
Khushal Khan Khattak Univeristy, Karak, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT05785312
Brief 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
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*
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khushal Khan Khattak Univeristy, Karak, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder, Major Depressive Disorder, Social Anxiety Disorder, Somatic Symptom, Panic Attacks, Obsessive-Compulsive Disorder and Symptoms
Keywords
EMDR, Online EMDR, Depression, Anxiety, Pakistan, Pilot Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Since this a comparative study, therefore after recruiting patients, the patients will be randomly allocated parallelly to the two arms. Arm One will will be Face-to-Face EMDR Therapy, in which the patients will receive standard EMDR therapy in a face-to-face meeting with the therapist. Arm two will be the online EMDR Therapy, in which the patients will receive EMDR therapy online via video conferencing. The patient will be randomly selected assigned to each arm with 1:1 allocation.
Masking
Participant
Masking Description
single blinded
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Face to Face Eye Movement Desensitization & Reprocessing Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Online Eye Movement Desensitization & Reprocessing Therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Online EMDR Therapy System
Intervention Description
Online EMDR Therapy System will be delivered through online computer system that will be specifically designed for delivering EMDR therapy online
Intervention Type
Other
Intervention Name(s)
Face to Face Eye Movement Desensitization & Reprocessing Therapy
Intervention Description
The Face to Face Eye Movement Desensitization & Reprocessing Therapy will be delivered in person inside clinician's room by following standard EMDR therapy protocol
Primary Outcome Measure Information:
Title
Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)
Description
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.
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)
Title
Assessing changes in symptom of Major Depressive Disorder with time (i.e., treatment course)
Description
Major Depressive Disorder by Beck Depression Inventory-II. Score of 30 or above will indicate that the patient is suffering from major depressive disorder
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)
Title
Assessing changes in symptom of Social Anxiety Disorder with time (i.e., treatment course)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Assessing changes in Panic symptoms with time (i.e., treatment course)
Description
Panic Attacks by Panic Disorder Severity Scale. Score of 20 or above will indicate that the patient is suffering form panic 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)
Title
Assessing changes in Somatic symptoms
Description
Somatic Symptoms by the Somatic Symptom Scale-8. Score of 11 or above will indicate that the patient is suffering from 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)
Title
Assessing changes in Obsessive symptoms with time (i.e., treatment course)
Description
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.
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)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
both males and females within the age range of 18 to 50 years
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Kushal Khan University
City
Lakki Marwat
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
28420
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anwar Khan, PhD
Phone
+92334560433
Email
akpashtoon1981@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
will only be shared after placing valid request

Learn more about this trial

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

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