Internet-delivered Prolonged Exposure Provided Soon After Traumic Events: An Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
研究概览
简要总结
The primary objective with this study is to investigate the short-term efficacy (primary endpoint at week 3) of Internet-delivered cognitive behavior therapy (ICBT) provided soon after trauma. The secondary objective is to investigate the long-term efficacy (primary endpoint at week 7) of ICBT. 100 participants recently exposed to a potentially traumatic event will be randomised to either ICBT or assessment only.
详细描述
PRIMARY OBJECTIVE
The primary objective with this study is to investigate the short-term efficacy (primary endpoint at week 3) of Internet-delivered cognitive behavior therapy (ICBT) provided soon after trauma.
SECONDARY OBJECTIVES The secondary objective is to investigate the long-term efficacy (primary endpoint at week 7) of ICBT.
Trial design: Randomized trial where participants are allocated to either ICBT (n=50) or control group (assessment only; n=50). Participants randomized to control group are subsequently offered identical ICBT treatment, so that all participants will eventually receive treatment.
All participants are assessed at baseline (W0), post-treatment (primary endpoint; W3) and at one-month follow-up (secondary endpoint; W7). Long-term follow-up assessments are also conducted at 6- and 12-months. The primary outcome measure is also measured weekly from baseline and up to the 1-month follow-up (W7).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Experienced psychological trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
- •At least mild clinical symptoms assessed using the PCL-5
- •≥ 18 years
- •Situated in Sweden
- •Informed consent
排除标准
- •Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the M.I.N.I.)
- •Not fluent speaking in Swedish
- •Receiving CBT for trauma-related symptoms
- •Ongoing trauma-related threat (e.g. living with a violent spouse)
结局指标
主要结局
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
时间窗: Baseline, weekly from baseline up to 1-month follow-up, 6 month follow up and 12 month follow up
Change in symptoms of post traumatic stress from baseline, during treatment to post treatment and follow up (6 and 12 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity.
次要结局
- Euroqol, EQ-5D(Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up)
- Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)(Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up)
- Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)(Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up)
- Adverse Events(Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up)
研究者
Erik Andersson
PhD, licensed psychologist
Karolinska Institutet