An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a Two-step Feasibility Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of intrusion of the traumatic memory
研究概览
简要总结
The primary objective with this study is to investigate the feasibility of an internet-delivered cognitive-behavioral (CBT) intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.
详细描述
Objective The primary objective with this study is to investigate the feasibility of an internet-delivered psychological intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.
Trial design We will first pre-pilot test the intervention- and assessment procedures in five participants (no randomization) which will be followed by a randomized controlled trial with waitlist control. The wait list control group will also receive treatment after the first group has finished.
SAMPLE SIZE 5 plus 30 participants.
ENDPOINTS Self-report assessment of daily intrusions at baseline and post-treatment
SECONDARY ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at baseline (and post-treatment Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) at baseline and post-treatment.
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
盲法说明
Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks.
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 according to criterium A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence) the past two months.
- •Ongoing intrusive memories from this traumatic event
- •≥ 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 MINI)
- •Not fluent speaking in Swedish
- •Receiving CBT for trauma
- •Ongoing trauma-related threat (e.g. living with a violent spouse)
研究组 & 干预措施
Internet-based exposure therapy
The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.
干预措施: Internet-based exposure therapy (Behavioral)
Wait list control
Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks.
结局指标
主要结局
Number of intrusion of the traumatic memory
时间窗: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Change in self-report assessment of daily intrusions at baseline (day 0-7) and post-treatment (day 28-35). The participants are each day asked to report number of intrusive memories during morning, afternoon, evening and night through a smart phone app. If the participants don't have access to a smart phone, pen and stencil will be used.
次要结局
- The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months)
- Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)(Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months)
- Euroqol, EQ-5D(Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months)
研究者
Erik Andersson
PhD
Karolinska Institutet