NCT05785312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 1, 2023

Last Update Submit

March 24, 2023

Conditions

Generalized Anxiety DisorderMajor Depressive DisorderSocial Anxiety DisorderSomatic SymptomPanic AttacksObsessive-Compulsive Disorder and Symptoms

Keywords

EMDROnline EMDRDepressionAnxietyPakistanPilot Study

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Assessing changes in Panic symptoms with time (i.e., treatment course)

    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

    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)

    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)

Study Arms (2)

Face to Face Eye Movement Desensitization & Reprocessing Therapy

EXPERIMENTAL

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

Online Eye Movement Desensitization & Reprocessing Therapy

ACTIVE COMPARATOR

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

Interventions

Online EMDR Therapy SystemDEVICE

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

Online Eye Movement Desensitization & Reprocessing Therapy
Face to Face Eye Movement Desensitization & Reprocessing TherapyOTHER

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

Face to Face Eye Movement Desensitization & Reprocessing Therapy

Eligibility Criteria

Age18 Months - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsboth males and females within the age range of 18 to 50 years
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kushal Khan University

Lakki, Khyber Pakhtunkhwa, 28420, Pakistan

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderDepressive Disorder, MajorPhobia, SocialMedically Unexplained SymptomsPanic DisorderObsessive-Compulsive DisorderDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental DisordersDepressive DisorderMood DisordersPhobic DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Anwar Khan, Director and Principal Investigator, Office of Research, Innovation and Commercialization

Study Record Dates

First Submitted

February 1, 2023

First Posted

March 27, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

will only be shared after placing valid request

Locations

PA(1)