Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 524
- 试验地点
- 6
- 主要终点
- Change in PTSD symptoms measured by the PTSD checklist (PCL5)
研究概览
简要总结
The purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (PTSD). The information learned by doing this study may help us to develop some target treatments for PTSD symptoms in survivors of stem cell transplant.
Participants in this study will be randomized to a mobile app or usual care. An assessment will be made after 4 weeks and a determination made of adding more intensive treatment. Participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of autologous or allogeneic HCT 1-5 years previously
- •Partial or complete remission (NED), may be receiving chemoprevention
- •Absence of severe psychological impairment (eg hospitalization for suicidality)
- •Approved for contact by oncologist
- •Able and willing to participate in a one-hour baseline interview
- •No prior CBT for PTSD
- •Owns a smart device with internet and email access
- •Able to read and write English
- •Significant PTSD symptoms as indicated by at least one of the following two criteria: probable cancer-related PTSD on the PCL5 by using the symptom cluster criteria; subthreshold or partial PTSD symptoms as determined by endorsement of reexperiencing cluster and less than or equal to 1 other symptom cluster
排除标准
- •If the participant does not fulfill the inclusion criteria
结局指标
主要结局
Change in PTSD symptoms measured by the PTSD checklist (PCL5)
时间窗: baseline, 4 weeks, 12 weeks
PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"
次要结局
- Change in distress measured by the Distress Thermometer v. 2018(baseline, 4 weeks, 12 weeks, and 6 months)
- Change in anxiety as measured by the PROMIS(baseline, 4 weeks, 12 weeks, and 6 months)
- Change in Quality of Life measured by the PROMIS QOL(baseline, 4 weeks, 12 weeks, and 6 months)
- User satisfaction as measured by a survey(baseline, 4 weeks, 12 weeks, and 6 months)
- Change in self-efficacy as measured by the Self-efficacy for Chronic Disease(baseline, 4 weeks, 12 weeks, and 6 months)
- Change in PTSD symptoms measured by the PTSD checklist (PCL5)(baseline, 12 weeks, 6 months)
- Change in depression as measured by the PROMIS(baseline, 4 weeks, 12 weeks, and 6 months)