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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435052
• Other study ID #: 111
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2024
• Source: Khushal Khan Khattak Univeristy, Karak, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression, Anxiety
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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)

Locations

Country	Name	City	State
Pakistan	Anwar Khan	Karak

Sponsors (1)

Lead Sponsor	Collaborator
Khushal Khan Khattak Univeristy, Karak, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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