Towards Evidence-based PTSD Care in Norwegian Specialist Health Services - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Changes in PTSD-symptoms
研究概览
简要总结
Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients.
The main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.
详细描述
Participants will be recruited from Asker DPS, Bærum DPS, Drammen DPS, and Ringerike DPS. They were referred to DPS for PTSD treatment, either by general practitioners, other primary health care services in their municipality, or psychiatric hospitals. This study is a longitudinal multi-assessment 2-arm RCT and does not include a treatment as usual group. The standard treatment protocol includes up to 24 weekly sessions. Conversely, if no discernible improvement is seen after 10 sessions, it is recommended to terminate treatment. The clinical assessment consists of self-administered questionnaires collected through CheckWare, which is a digital platform developed for healthcare services. They will be asked to report symptoms of PTSD, depression, anxiety, psychosis, alcohol/drug use, functional outcomes, working alliance. Before treatment starts, patients will complete baseline assessments. Throughout the treatment phase, all patients will be requested to fill out self-administered questionnaires after each session.
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
The Investigator will be blinded to the random allocation of patients, but will have knowledge of the interventions when treatment begins.
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
- •age ≥18 years
- •meeting criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score ≥23
排除标准
- •insufficient mastery of the Norwegian language
- •severe intellectual impairment (estimated IQ of 70 or less)
- •comorbid psychiatric illnesses in an acute phase where other types of treatment need to be prioritized (e.g. hospitalization)
- •history of EMDR or CT-PTSD treatment
研究组 & 干预措施
Eye Movement Desensitization and Reprocessing
Patients will receive EMDR as their main treatment method of PTSD. EMDR processes trauma memories while engaging in bilateral stimulation to help rewire the brain's response to trauma and decrease emotional distress.
干预措施: Eye movement desensitization and reprocessing (Behavioral)
Cognitive Therapy for PTSD
Patients will receive CT-PTSD as their main treatment method of PTSD. CT-PTSD focuses on techniques such as cognitive restructuring and exposure therapy to help individuals reframe trauma and reduce intrusive memories and emotional distress.
干预措施: Cognitive therapy for PTSD (Behavioral)
结局指标
主要结局
Changes in PTSD-symptoms
时间窗: From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months
Changes in PTSD checklist for DSM-V (PCL-5) scores. The PCL-5 consists of 20 items on a 5-point Likert scale ranging from 0-4. Total scores range from 0-80, where a higher score signifies a worse outcome.
次要结局
- Changes in comorbid illnesses(From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months)
- Changes in functional outcomes(From enrollment to the end of treatment at 24 weeks. Follow up at 3, 6 and 12 months)