Efficacy of Eye Movement Desensitization and Reprocessing Versus Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder and Comorbid Disorders in Pakistan: A Full-Fledged Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Post-traumatic stress disorder symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to participants' treatment allocation. The clinicians delivering EMDR and CBT were not blinded because they administered the assigned psychotherapy, and participants were aware of the treatment they received.
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 15 to 60 years.
- •Confirmed diagnosis of post-traumatic stress disorder (PTSD), with PTSD identified as the primary clinical condition.
- •Associated symptoms of depression and anxiety at screening.
- •Able to participate in face-to-face psychotherapy and perform the basic eye and hand movements required for the treatment procedures.
- •Able to provide informed consent and communicate sufficiently to participate meaningfully in assessment and psychotherapy.
排除标准
- •Younger than 15 years or older than 60 years.
- •Significant limitations in eye or hand movement, or inability to perform the basic movements required for participation in the treatment procedures.
- •Prolonged unconsciousness or otherwise unable to maintain sufficient consciousness to participate meaningfully in assessment or psychotherapy.
- •Does not meet the screening criteria for PTSD, or PTSD is not the primary clinical condition.
- •Severe intellectual impairment that substantially limits the ability to understand, communicate, or participate in the assessment and psychotherapy procedures.
研究组 & 干预措施
Eye Movement Desensitization and Reprocessing (EMDR) Therapy
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
干预措施: Eye Movement Desensitization and Reprocessing (EMDR) Therapy (Behavioral)
Cognitive Behavioral Therapy (CBT)
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.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
结局指标
主要结局
Post-traumatic stress disorder symptoms
时间窗: 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)
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.
Post-traumatic stress disorder
时间窗: 2 years
Post-traumatic stress disorder (PTSD) will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 scores will be utilized to determine the severity of PTSD symptoms. Typically, a CAPS-5 score of 40 or above will serve as the cutoff point for diagnosing PTSD.
次要结局
- Depressive symptoms(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(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 and Anxiety Symptoms(2 years)
研究者
Dr. Anwar Khan
Dr. Anwar Khan, Assistant Professor of Organizational Psychology
Khushal Khan Khattak Univeristy, Karak, Pakistan