Efficacy of EMDR Versus CBT for Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study

September 21, 2026 updated by: Dr. Anwar Khan, Khushal Khan Khattak Univeristy, Karak, Pakistan

Efficacy of Eye Movement Desensitization and Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study

Post-Traumatic Stress Disorder (PTSD) is commonly accompanied by symptoms of depression and anxiety. Eye Movement Desensitization and Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT) are evidence-based psychological treatments for PTSD, but there has been limited research on their feasibility, cultural applicability, and comparative effects in Pakistan.

This study was conducted as a randomized controlled feasibility-pilot study before undertaking a larger definitive randomized controlled trial. The study was carried out in two main phases. In the first phase, selected diagnostic measures for PTSD, depression, and anxiety were translated into Urdu and evaluated for their psychometric and cross-language properties in a Pakistani clinical population. The measures included the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI).

The study also included cultural adaptation and feasibility assessment of the EMDR and trauma-focused CBT treatment protocols, together with assessment of treatment fidelity and therapist competence.

In the randomized pilot phase, patients with PTSD and related depressive and anxiety symptoms were recruited from two rehabilitation centres in Peshawar, Pakistan. Forty eligible patients were randomly allocated in a 1:1 ratio to either EMDR (n=20) or CBT (n=20). Participants remained in their assigned treatment group.

PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment at approximately six weeks, at the end of treatment at approximately 12 weeks, and at a two-month follow-up. Treatment was delivered by trained clinical psychologists using the selected EMDR and CBT protocols.

The main purpose of this feasibility-pilot study was to determine whether the assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and comparative evaluation of EMDR and CBT were feasible for a subsequent larger randomized controlled trial in Pakistan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Rationale and Development

This study originated from an earlier planned randomized controlled trial comparing Eye Movement Desensitization and Reprocessing (EMDR) with Cognitive Behavioral Therapy (CBT) for Post-Traumatic Stress Disorder (PTSD) and associated symptoms in Pakistan. Following further methodological development, the project was implemented as a feasibility-pilot study to establish the suitability of assessment procedures, culturally adapted treatment protocols, recruitment procedures, treatment delivery, and study methods before undertaking a subsequent larger randomized controlled trial.

Phase One: Assessment-Tool Translation and Psychometric Evaluation

The first phase focused on preparation and evaluation of the assessment instruments that would subsequently be used in the randomized pilot phase. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), Hamilton Depression Rating Scale (HDRS), and State-Trait Anxiety Inventory (STAI) were used to assess PTSD, depressive symptoms, and anxiety symptoms, respectively. The instruments were translated into Urdu and their psychometric and cross-language properties were examined in a Pakistani clinical population.

During July and August 2020, patients attending two rehabilitation centres were screened for this preliminary phase. An initial sample of 50 patients was selected using consecutive sampling. Twenty-five participants were assessed using the English versions of the diagnostic tools and 25 using the Urdu versions. An additional 15 consecutive patients were later included for further English-Urdu cross-language analyses. No EMDR or CBT psychotherapy was delivered as part of this assessment-tool validation phase.

Cultural Adaptation and Treatment Feasibility

The broader feasibility programme also included translation and cultural adaptation of the EMDR and trauma-focused CBT treatment protocols. Adaptation work incorporated review of relevant literature and expert input. Treatment fidelity was subsequently examined through assessment of adherence to the treatment protocols and therapist competence.

Randomized Pilot Phase

The clinical intervention component used a prospective, single-blinded randomized controlled pilot design. It was conducted at the Paraplegic Center and the Psychiatry Unit and Rehabilitation Center at Lady Reading Hospital in Peshawar, Pakistan. The second centre was added because the COVID-19 pandemic reduced patient attendance at the initially selected centre.

Patients were recruited using consecutive sampling with rolling recruitment. A total of 108 individuals were screened for eligibility; 48 were ineligible and 20 did not proceed further. Forty eligible patients were randomized in a 1:1 ratio to either EMDR (n=20) or CBT (n=20) using a concealed computer-generated random allocation procedure. Participants remained in their assigned treatment condition; the study did not use a crossover design.

Interventions and Assessments

Psychotherapy was delivered by three clinical psychologists trained in EMDR and CBT. Treatment generally ranged from 6 to 12 sessions, usually delivered once per week, with two additional follow-up sessions approximately two months later. The EMDR intervention followed an eight-stage PTSD-focused protocol, while the CBT intervention followed a ten-stage trauma-focused CBT protocol.

PTSD, depressive, and anxiety symptoms were assessed at four time points: baseline/pre-treatment (T1), during treatment at approximately six weeks (T2), post-treatment at approximately 12 weeks (T3), and approximately two months after treatment at follow-up (T4). CAPS-5 was used for PTSD symptoms, HDRS for depressive symptoms, and STAI for anxiety symptoms.

Analysis and Purpose of the Pilot Study

The study examined changes in PTSD, depressive, and anxiety symptoms over time and explored the comparative performance of EMDR and CBT. Analyses included descriptive statistics, repeated-measures analyses, non-inferiority analyses, effect-size estimation, and longitudinal analyses examining associations between PTSD and comorbid symptoms. The final report also assessed treatment fidelity and therapist competence.

The primary purpose of this feasibility-pilot study was to generate preliminary evidence on whether the assessment procedures, culturally adapted interventions, treatment delivery, recruitment strategy, follow-up procedures, and analytic framework were suitable for a later larger randomized controlled trial in Pakistan. The final report specifically recommended subsequent testing with a substantially larger sample.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Peshawar, Pakistan, 25000
        • Paraplegic Center Peshawar
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Psychiatry Unit & Rehabilitation Center, Lady Reading Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 15-60 years. Met screening criteria for PTSD, with PTSD as the primary clinical problem. Able to participate in the required assessments and psychotherapeutic procedures.

Exclusion Criteria:

Patients below the age of 15 years and above 60 years. Patients who were unable to move their hands or eyes and/or unable to perform basic movements.

Patients who were unconscious for prolonged periods and unable to recover consciousness.

Patients who did not meet the screening criteria for PTSD, or for whom PTSD was not the primary problem.

Patients with severe intellectual impairments that would substantially limit communication and participation in psychotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eye Movement Desensitization and Reprocessing Therapy

Participants assigned to this arm received Eye Movement Desensitization and Reprocessing (EMDR) therapy for PTSD and comorbid depressive and anxiety symptoms using the culturally adapted EMDR protocol. Treatment was delivered individually by trained clinical psychologists. Sessions ranged from approximately 6 to 12 sessions, generally once per week, with additional follow-up sessions as clinically indicated.
Behavioral: Eye Movement Desensitization and Reprocessing Therapy

Eye Movement Desensitization and Reprocessing (EMDR) therapy was delivered using an eight-stage protocol for PTSD and comorbid symptoms. Treatment was delivered individually by trained clinical psychologists and included approximately 6 to 12 sessions, generally once weekly, with follow-up sessions as required.

Other Names:
  • EMDR Therapy
Active Comparator: Cognitive Behavioral Therapy

Participants assigned to this arm received trauma-focused Cognitive Behavioral Therapy (CBT) for PTSD and comorbid depressive and anxiety symptoms using the culturally adapted CBT protocol. Treatment was delivered individually by trained clinical psychologists. Sessions ranged from approximately 6 to 12 sessions, generally once per week, with additional follow-up sessions as clinically indicated.
Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Trauma-focused Cognitive Behavioral Therapy was delivered using a ten-stage CBT protocol for PTSD and comorbid symptoms. Treatment was delivered individually by trained clinical psychologists and included approximately 6 to 12 sessions, generally once weekly, with follow-up sessions as required.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5
Time Frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).

Post-traumatic stress disorder symptom severity was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 assesses the severity of DSM-5 PTSD symptoms. Symptom severity ratings range from 0 (absent) to 4 (extreme/incapacitating), with higher scores indicating greater PTSD symptom severity. Changes in CAPS-5 scores were assessed across the treatment and follow-up periods to examine change in PTSD symptoms over time and differences between the EMDR and CBT treatment groups.
Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HDRS-17)
Time Frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).

Depressive symptoms were assessed using the 17-item Hamilton Depression Rating Scale (HDRS-17). The instrument assesses the severity of depressive symptoms including depressed mood, guilt, suicidality, sleep disturbance, psychomotor symptoms, anxiety-related symptoms and somatic symptoms. Higher scores indicate greater depressive symptom severity. Changes in HDRS scores were assessed across treatment and follow-up to examine changes in depressive symptoms and differences between the EMDR and CBT treatment groups.
Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Change in Anxiety Symptoms Assessed by the State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).

Anxiety symptoms were assessed using the State-Trait Anxiety Inventory (STAI). The STAI contains 40 items comprising State Anxiety and Trait Anxiety components. Items are rated on a 4-point scale, with higher scores indicating greater anxiety symptom severity after appropriate scoring. Changes in STAI scores were assessed across treatment and follow-up to examine change in anxiety symptoms and differences between the EMDR and CBT treatment groups.
Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Khushal Khan Khattak Univeristy, Karak, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KhushalKhanKhattakU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant-level data will not be shared publicly because the study involves sensitive clinical and psychotherapy data. Aggregate findings may be reported in peer-reviewed publications and scientific presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings