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

NCT ID: NCT05785312

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Generalized Anxiety Disorder Major Depressive Disorder Social Anxiety Disorder Somatic Symptom Panic Attacks Obsessive-Compulsive Disorder and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
single blinded

Study Groups

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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.

Group Type EXPERIMENTAL

Face to Face Eye Movement Desensitization & Reprocessing Therapy

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Online EMDR Therapy System

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khushal Khan Khattak Univeristy, Karak, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Dr. Anwar Khan

Dr. Anwar Khan, Director and Principal Investigator, Office of Research, Innovation and Commercialization

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kushal Khan University

Lakki, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Facility Contacts

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Anwar Khan, PhD

Role: primary

+92334560433

Other Identifiers

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12321

Identifier Type: -

Identifier Source: org_study_id

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