Efficacy of a Guided Internet-based Trauma-focused CBT Intervention 'Spring' for ICD-11 Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change in International Trauma Interview (ITI) PTSD score post-treatment
研究概览
简要总结
The main aim of the study is to evaluate the efficacy of the Lithuanian version of the internet-based guided self-help programme (Spring) in reducing ICD-11 PTSD symptoms.
详细描述
Spring is an online guided self-help programme for the reduction of posttraumatic stress disorder symptoms. It is based on the principles of trauma-focused cognitive behavioral therapy and consists of 8 steps covering psychoeducation, grounding techniques, management of anxiety, behavioral activation, imaginal exposure, cognitive restructuring, in vivo exposure, and prevention of relapse. The user of the programme also receives up to 3 hours of therapist guidance. Originally Spring was developed by the research team at Cardiff University. In the current study, the most recent second version of the Spring programme adapted to the Lithuanian population will be used. The main aim of the study is to evaluate the efficacy of the Lithuanian version of the Spring programme in reducing ICD-11 posttraumatic stress disorder symptoms.
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
Semi-structured interviews will be administered by researchers blind to randomization allocation at baseline, 10 and 22 weeks after randomization. Self-report data will be collected via a secure online platform, so it will help avoid ascertainment bias in the measurement of outcomes.
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
- •Aged 18 years or over
- •Ability to read and write fluently in Lithuanian
- •Have regular access to a device with an internet connection to use the programme
- •Provide informed consent for participation
- •Experience PTSD symptoms followed by a non-prolonged and non-repetitive traumatic experience as measured by the ITI
排除标准
- •Regularly seeing a therapist or counsellor for mental health issues
- •Change in psychotropic medication in the last month
- •CPTSD diagnosis
- •Psychosis
- •Severe suicide risk
- •Substance dependence
- •Experiencing ongoing threat
结局指标
主要结局
Change in International Trauma Interview (ITI) PTSD score post-treatment
时间窗: baseline; 10 weeks after randomization
The ITI is a semi-structured clinical interview for the assessment of symptoms of ICD-11 posttraumatic stress disorder. The total ITI score measuring symptoms of PTSD may range from 0 to 24. Higher scores indicate greater symptom severity.
次要结局
- Change in Trauma Related Shame Inventory - Short Form (TRSI-SF)(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Readiness for Therapy Questionnaire (RTQ)(Baseline (before start using the intervention programme))
- Change in Brief Version of the Posttraumatic Cognitions Inventory (PTCI-9)(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Change in International Anxiety Questionnaire (IAQ) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Working Alliance Inventory for guided Internet Interventions (WAI-I)(5 and 10 weeks after randomization (immediate treatment group only); 27 and 32 weeks after randomization (delayed treatment group only))
- Change in International Trauma Interview (ITI) DSO score(baseline; 10 weeks after randomization; 22 weeks after randomization)
- Change in World Health Organization Well-Being Index (WHO-5) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Change in International Trauma Interview (ITI) PTSD score at a three-month follow-up(baseline; 22 weeks after randomization)
- Change in International Trauma Questionnaire (ITQ) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Change in International Depression Questionnaire (IDQ) score(baseline; 10 weeks after randomization; 22 weeks after randomization; 32 weeks after randomization (delayed treatment group only))
- Patient satisfaction questionnaire (ZUF-8)(10 weeks after randomization (immediate treatment group only); 32 weeks after randomization (delayed treatment group only))
- The Treatment Expectation Questionnaire (TEX-Q)(Baseline (before start using the intervention programme))