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

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.