An interventional study of Eye Movement Desensitization and Reprocessing Therapy and Trauma-Focused Cognitive Behavioral Therapy in Post-Traumatic Stress Disorder, Depressive Symptoms and Anxiety Symptoms, sponsored by Khushal Khan Khattak Univeristy, Karak, Pakistan. Completed at 2 sites in Pakistan. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Khushal Khan Khattak Univeristy, Karak, Pakistan · Not applicable, Interventional, and Treatment
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 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.
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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.
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
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
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
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.
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.
Time frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HDRS-17)
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.
Time frame: 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)
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.
Time frame: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
Plan to share: No — 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.
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Khushal Khan Khattak Univeristy, Karak, Pakistan