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Completed
NCT04021329
Efficacy of EMDR Versus CBT for Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study
Conditions: Post-Traumatic Stress Disorder, Depressive Symptoms, Anxiety Symptoms
Sex: All
Ages: 15 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Khushal Khan Khattak Univeristy, Karak, Pakistan
Location: Psychiatry Unit & Rehabilitation Center, Lady Reading Hospital Peshawar KPK
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT04021329). StuddyBuddy aggregates publicly available trial information.