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COMPLETED
NCT04021329
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Efficacy of EMDR Versus CBT for Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study

Sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

15 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-08-05

Completion Date

2021-12-05

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

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.

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.

Locations (2)

Psychiatry Unit & Rehabilitation Center, Lady Reading Hospital

Peshawar, KPK, Pakistan

Paraplegic Center Peshawar

Peshawar, Pakistan