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

NCT04021329 | Completed

• 1 other identifier: KhushalKhanKhattakU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder; Depressive Symptoms; Anxiety Symptoms

Keywords

Eye Movement Desensitization and Reprocessing; Cognitive Behavioral Therapy; Post-Traumatic Stress Disorder; Depressive Symptoms; Anxiety Symptoms; Feasibility Study; Pilot Study; Pakistan

Outcome Measures

Primary Outcomes (1)

• Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5

  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 Outcomes (2)

• Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HDRS-17)

  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)

  Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).

Study Arms (2)

Eye Movement Desensitization and Reprocessing Therapy

EXPERIMENTAL

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

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Interventions

Eye Movement Desensitization and Reprocessing Therapy BEHAVIORAL

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.

Also known as: EMDR Therapy

Eye Movement Desensitization and Reprocessing Therapy

Trauma-Focused Cognitive Behavioral Therapy BEHAVIORAL

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.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khushal Khan Khattak Univeristy, Karak, Pakistan: lead

Study Sites (2)

Psychiatry Unit & Rehabilitation Center, Lady Reading Hospital

Peshawar, KPK, 25000, Pakistan

Location

Paraplegic Center Peshawar

Peshawar, 25000, Pakistan

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to treatment allocation. Participants and treating therapists were aware of the assigned psychotherapy because masking of treatment condition was not practically feasible for EMDR and CBT delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective, two-arm, randomized controlled feasibility-pilot study with repeated assessments. Eligible participants were randomly allocated in a 1:1 ratio to either EMDR or CBT and remained in their assigned treatment group throughout the study. Assessments were conducted at baseline, during treatment, post-treatment, and at two-month follow-up.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: August 5, 2020
• Primary Completion: November 22, 2021
• Study Completion: December 5, 2021
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)