An interventional study of Eye Movement Desensitization and Reprocessing (EMDR) Therapy and Cognitive Behavioral Therapy (CBT) in Post-Traumatic Stress Disorder, Depression and Anxiety, sponsored by Khushal Khan Khattak Univeristy, Karak, Pakistan. Completed at 3 sites in Pakistan. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Khushal Khan Khattak Univeristy, Karak, Pakistan · Not applicable, Interventional, and Treatment
This randomized controlled trial compares Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) in Pakistan. The study examines whether EMDR is at least as effective as CBT in reducing PTSD symptoms over time. It also assesses changes in symptoms of depression and anxiety that commonly occur alongside PTSD. Participants are randomly assigned to receive either EMDR or CBT, and their symptoms are assessed at different stages of treatment and follow-up.
This study is a multi-center, single-blind, two-group randomized controlled trial designed to compare Eye Movement Desensitization and Reprocessing (EMDR) therapy with Cognitive Behavioral Therapy (CBT) for the treatment of post-traumatic stress disorder (PTSD) and associated symptoms of depression and anxiety.
The study is conducted in sequential phases. During the initial phase, the psychometric properties of the assessment measures are examined and treatment fidelity is evaluated to determine whether EMDR and CBT are delivered consistently and in accordance with their respective treatment protocols. The subsequent phase focuses on the comparative clinical effectiveness of EMDR and CBT.
Eligible participants with PTSD are randomly allocated to either the EMDR or CBT treatment condition using a covariate-adaptive stratified randomization procedure with a 1:1 allocation ratio. Treatment is delivered face-to-face by clinical psychologists trained in the respective psychotherapeutic approaches. The number of treatment sessions varies according to participants' clinical needs and symptom severity.
The primary objective is to examine whether EMDR is non-inferior to CBT in reducing PTSD symptoms. Additional objectives are to examine changes in PTSD symptoms over the course of treatment and follow-up, assess changes in associated depressive and anxiety symptoms, and explore the relationship between changes in PTSD symptoms and changes in these comorbid symptoms.
PTSD symptoms are assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Depressive symptoms are assessed using the Hamilton Depression Rating Scale (HDRS), and anxiety symptoms are assessed using the State-Trait Anxiety Inventory (STAI). Assessments are conducted at baseline, during treatment, at the end of treatment, and at follow-up.
Treatment fidelity is also evaluated by assessing therapists' adherence to the EMDR and CBT protocols and their competence in delivering the interventions.
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This study's enrollment of 80 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
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Participants assigned to this arm received face-to-face Eye Movement Desensitization and Reprocessing (EMDR) therapy delivered by clinical psychologists trained in EMDR. Treatment followed an eight-stage EMDR protocol for PTSD, with culturally adapted procedures used where appropriate. The number of sessions varied according to symptom severity and clinical need, generally ranging from 6 to 14 sessions, typically delivered once per week. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment, at the end of treatment, and at follow-up
Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) Therapy
Participants assigned to this arm received face-to-face Cognitive Behavioral Therapy (CBT) delivered by clinical psychologists trained in CBT. Treatment followed a structured trauma-focused CBT protocol, with culturally adapted procedures used where appropriate. The number of sessions varied according to symptom severity and clinical need, generally ranging from 6 to 14 sessions, typically delivered once per week. PTSD, depressive, and anxiety symptoms were assessed at baseline, during treatment, at the end of treatment, and at follow-up.
Behavioral: Cognitive Behavioral Therapy (CBT)
Eye Movement Desensitization and Reprocessing (EMDR) therapy was delivered face-to-face by clinical psychologists trained and certified in EMDR. Treatment followed an eight-stage EMDR protocol for post-traumatic stress disorder (PTSD), incorporating culturally adapted procedures where appropriate for the Pakistani clinical context. Treatment included history-taking and treatment planning, preparation, assessment, desensitization using bilateral stimulation, installation of adaptive cognitions, body scan, closure, and reevaluation. The number of sessions was determined according to participants' symptom severity and clinical needs and generally ranged from 6 to 14 sessions, typically delivered once per week.
Cognitive Behavioral Therapy (CBT) was delivered face-to-face by clinical psychologists trained and certified in CBT. Treatment followed a structured trauma-focused CBT protocol for post-traumatic stress disorder (PTSD), with culturally adapted procedures used where appropriate for the Pakistani clinical context. Treatment included assessment and engagement, psychoeducation, relaxation, affective modulation, cognitive coping and restructuring, trauma narrative work, exposure-based procedures, caregiver involvement where appropriate, and enhancement of safety. The number of sessions was determined according to participants' symptom severity and clinical needs and generally ranged from 6 to 14 sessions, typically delivered once per week.
Post-traumatic stress disorder symptoms
PTSD symptom severity was assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in PTSD symptoms over time and to compare the EMDR and CBT treatment groups.
Time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Depressive symptoms
Depressive symptoms were assessed using the Hamilton Depression Rating Scale (HDRS). Scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in depressive symptoms over time in the EMDR and CBT treatment groups.
Time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Anxiety symptoms
Anxiety symptoms were assessed using the State-Trait Anxiety Inventory (STAI). Scores were collected at baseline, during treatment, at the end of treatment, and at follow-up to evaluate changes in anxiety symptoms over time in the EMDR and CBT treatment groups.
Time frame: Baseline (before treatment), mid-treatment (approximately halfway through the treatment course), end of treatment (following completion of treatment), and follow-up (approximately 1 to 3 months after treatment completion)
Plan to share: No — Individual participant data (IPD) will not be shared. The study involves sensitive mental health, trauma-related, and clinical information, and the consent and ethical framework for the study did not provide for public or external sharing of individual-level participant data. Aggregate study findings may be reported in publications and other research outputs.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
Khushal Khan Khattak Univeristy, Karak, Pakistan