Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

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

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

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder; Depression, Anxiety
• Intervention / Treatment: Behavioral: Eye Movement Desensitization & Reprocessing Therapy; Behavioral: Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karak, Pakistan, 27200
    • Recruiting
    • Anwar Khan
    • Contact: Anwar Khan; Phone Number: 03345606406; Email: akpashtoon1981@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

reverse of the exclusion critera

Exclusion Criteria:

The following patients will be excluded:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eye Movement Desensitization & Reprocessing Therapy; Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy (CBT) in the treatment of Post-Traumatic Stress Disorder (PTSD) in Pakistan.	Behavioral: Eye Movement Desensitization & Reprocessing Therapy; Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.
Active Comparator: Cognitive Behavioral Therapy; Cognitive Behavioral Therapy (CBT) will be delivered face-to-face by a psychotherapist in a total of 14 sessions, with one session per week. The efficacy of CBT will be compared with Eye Movement Desensitization and Reprocessing therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.	Behavioral: Cognitive Behavioral Therapy; Cognitive Behavioral Therapy will be comparatively checked with Eye Movement Desensitization & Reprocessing Therapy for its efficacy. It will be administered by psychotherapist in 14 sessions (each session per week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-traumatic stress disorder	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive and Anxiety Symptoms	Depressive and anxiety symptoms will be measured using the Hamilton Depression Rating Scale and the State-Trait Anxiety Inventory, respectively. A Hamilton Depression Rating Scale score of 20 or above, and a State-Trait Anxiety Inventory score of 40 or above, will serve as the cutoff points.	2 years

Collaborators and Investigators

• Sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: CBT; Pakistan; Post Traumatic Stress Disorder; EMDR
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 111 (Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: can be shared on 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