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Clinical Trials/NCT06435052
NCT06435052
Recruiting
Not Applicable

Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Full-fledged Randomized Controlled Trial

Khushal Khan Khattak Univeristy, Karak, Pakistan1 site in 1 country200 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
Khushal Khan Khattak Univeristy, Karak, Pakistan
Enrollment
200
Locations
1
Primary Endpoint
Post-traumatic stress disorder
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

Detailed Description

This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan. It will be a single blind multi-center RCT with two arms (EMDR and CBT). This study will broadly work on following aims: 1. Initially the comparative efficacy of EMDR and CBT (i.e., standard face-to-face protcols) will be determined on large scale in Pakistan by: 1. Examining whether EMDR is non-inferior to CBT in the treatment of PTSD and its two comorbidities in Pakistan. 2. Studying changes in the symptoms (i.e., reduction in the PTSD and comorbid symptoms with the passage of time) after administering EMDR and CBT. The level of change in the symptoms will ultimately help in determining the extent of effectiveness of both therapies. 3. Examine the reciprocal relationship between PTSD and comorbid symptoms for knowing whether any reduction in the PTSD symptoms can help in reducing the comorbid symptoms after administering EMDR and CBT. 2. At the mean time work on the design and development of virtual EMDR and CBT therapies (i.e., Web-based and Mobile Applications) will also be started. The initial prototypes will be tested for its comparative efficacy. Later once the final versions will be developed then it will be also tested for its comparative efficacy on large scale in Pakistan.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
August 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Khushal Khan Khattak Univeristy, Karak, Pakistan
Responsible Party
Principal Investigator
Principal Investigator

Dr. Anwar Khan

Dr. Anwar Khan, Assistant Professor of Organizational Psychology

Khushal Khan Khattak Univeristy, Karak, Pakistan

Eligibility Criteria

Inclusion Criteria

  • reverse of the exclusion critera

Exclusion Criteria

  • The following patients will be excluded:
  • Patients below the age of 15 years and above 60 years, since this study is neither on children nor on old aged patients;
  • Patients who can't move their hands and eyes/or can't perform basic movements;
  • Patients who are unconscious for longer periods and unable to recover consciousness;
  • Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;
  • Patients with severe intellectual impairments, since such patients are difficult to communicate

Outcomes

Primary Outcomes

Post-traumatic stress disorder

Time Frame: 2 years

Post-traumatic stress disorder (PTSD) will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 scores will be utilized to determine the severity of PTSD symptoms. Typically, a CAPS-5 score of 40 or above will serve as the cutoff point for diagnosing PTSD.

Secondary Outcomes

  • Depressive and Anxiety Symptoms(2 years)

Study Sites (1)

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