Efficacy of Eye Movement Desensitization and Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5
研究概览
简要总结
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.
详细描述
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.
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 treatment allocation. Participants and treating therapists were aware of the assigned psychotherapy because masking of treatment condition was not practically feasible for EMDR and CBT delivery.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
Eye Movement Desensitization and Reprocessing Therapy
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.
干预措施: Eye Movement Desensitization and Reprocessing Therapy (Behavioral)
Cognitive Behavioral 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.
干预措施: Trauma-Focused Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Change in Post-Traumatic Stress Disorder Symptom Severity Assessed by CAPS-5
时间窗: Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).
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.
Measurement of Change in the symptoms of Post Traumatic Stress Disorder
时间窗: 1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).
Clinician-Administered Post Traumatic Stress Disorder Scale-5 (Weathers, Blake, et al., 2013) These diagnostic tools will be used to assess the symptoms of Post Traumatic Stress Disorder. Any changes in the level of PTSD will be noted with respect to Pre, Mid and Post treatment stages The total symptom severity score is calculated by summing severity scores for the 20 * Criterion A (items 1-5); (Exposure to actual or threatened death) * Criterion B (items 6-7); (Presence of intrusion symptoms associated with the traumatic events) * Criterion C (items 8-14); (Persistent avoidance of stimuli associated with the traumatic events) * Criterion D (items 15-20). (Negative alterations in cognitions and mood associated with the traumatic events) Severity Rating 0. Absent: 1. Mild / subthreshold:. 2. Moderate / threshold: 3. Severe / markedly elevated: 4. Extreme / incapacitating:
Measurement of Socio Demographic Profile
时间窗: 1st week at start of treatment, i.e, from date of randomization
Socio-demographic characteristics of the patients, like age, gender, marital status, occupation and social background
次要结局
- Change in Depressive Symptom Severity Assessed by the Hamilton Depression Rating Scale (HDRS-17)(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)(Baseline/pre-treatment (T1), 6 weeks during treatment (T2), 12 weeks/end of treatment (T3), and 2 months after treatment completion (T4).)
- Measurement of Change in the symptoms of major depression(1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).)
研究者
Dr. Anwar Khan
Assistant Professor
Khushal Khan Khattak Univeristy, Karak, Pakistan