跳至主要内容
临床试验/NCT03469128
NCT03469128已完成1 期

Cognitive Processing Therapy Versus Sertraline for the Treatment of Post-traumatic Stress Disorder & Substance Use Disorder Egyptian Patients

British University In Egypt0 个研究点目标入组 150 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
150
主要终点
Questionnaire

研究概览

简要总结

The present research was aimed at comparing the effects of Cognitive Processing Therapy (CPT) with the effects of Sertraline in treating patients who have dual diagnosis PTSD & SUD. The present study examines the extent to which CPT is effective in treating PTSD symptoms for patients with PTSD and SUD.

详细描述

Patients with co-occurrence PTSD & SUD disorders were grouped into 3 groups: first: Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT. Second: were treated by Sertraline. Third: a placebo control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

This is a three-group, repeated-measure, parallel-group, Randomized Control Trial design. Patients, study psychiatrists, and assessors were blind to treatment condition assignment. Randomization blocks of three were used to maintain equal group size. The 3-month assessment serves as the post-treatment. Outcome assessments were PTSD severity, substance use severity, and depression. The pharmacy of Ain Shams Hospital created sertraline and matching placebo kits with single-identifier numbers based on a random code that was provided to an unblinded statistician who will instruct the psychiatrist how to distribute kits to patients.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with SUD

排除标准

  • Patients diagnosed with other psychotic disorders

研究组 & 干预措施

Cognitive processing therapy

Active Comparator

Cognitive Processing Therapy (CPT) in which participants completed 12 sessions of CPT

干预措施: Cognitive processing therapy (Behavioral)

Sertraline

Active Comparator

Patients with co-occurrence PTSD & SUD disorders were treated by Sertraline.

干预措施: Sertraline (Drug)

Control group

Placebo Comparator

Placebo Control group

干预措施: Placebo Control (Other)

结局指标

主要结局

Questionnaire

时间窗: 3 Months

A psychological parameter will be measured to check the efficacy of CPT against medication for the treatment for co-current PTSD \& SUD. The groups will be examined to show if any significant reductions in PTSD and SUD symptoms was obtained over time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amani Safwat Albrazi

Principal Investigator

British University In Egypt

相似试验