Imagery Rescripting for Childhood Trauma related PTSD: A Multiple baseline study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PTSD Symptom severity as assessed by PCL-5
研究概览
简要总结
The protocol aims to study the efficacy of Imagery Rescripting as a standalone treatment for individuals with PTSD with a history of childhood trauma. Participants will be recruited after screening based on inclusion-exclusion criteria, screening tools, and those who consent to participate in the study. The study follows a multiple baseline design so they will be randomly assigned to any of the 4 baseline periods; 5 weeks, 6 weeks, 7 weeks, and 8 weeks. Upon completion of the respective baselines, participants will enter the exploration phase, which will consist of 5 weekly sessions and then the intervention phase which will consist of 12-16 twice-a-week sessions. The protocol by Arntz (2019) will be used in the intervention phase. The assessments for all primary and secondary outcomes will occur at 5 time points- before baseline, after baseline, before exploration, before intervention, after intervention, and at 3 months follow-up. Assessments using PCL-5 and VAS will take place weekly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with a primary diagnosis of PTSD (according to DSM-5 criteria) as assessed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and those who obtain a score of 33 and above on Post Traumatic Stress Disorder Checklist (PCL-5) or Individuals with a primary diagnosis of CPTSD (according to ICD 11 criteria) Individuals having experienced the worst traumatic event (defined according to the DSM-5) before the age of 16 and agree that this trauma will be the focus of treatment.
- •Individuals belonging to the age group of 18-60 years Individuals who have undergone psychological interventions for PTSD but continue to fulfill the criteria for the diagnosis of PTSD (Score of 33 and above on PCL-5) Individuals who can read and write English.
排除标准
- •Individuals with schizophrenia, bipolar disorder with current episode mania/ severe depression, current substance use/substance dependence/harmful use not in remission for at least 3 months except nicotine use Individuals with an organic brain disorder, neurodevelopmental disorders, or intelligence below the average category Individuals with severe symptoms of axis I disorders that might interfere with their engagement in therapy Individuals with acute suicidal risk or self-harm Individuals with ongoing trauma.
结局指标
主要结局
PTSD Symptom severity as assessed by PCL-5
时间窗: 5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.
次要结局
- PTSD related cognitions(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Emotional regulation(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Anger(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Guilt(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Shame(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Anxiety(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Depression(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
- Well-being(5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase.)
研究者
Anju S Nair
National Institute of Mental Health and Neurosciences