跳至主要内容
临床试验/NCT03302312
NCT03302312已完成不适用

A Randomized, Sham-procedure-controlled, Blinded Study to Evaluate the Effectiveness and Acceptability of Right-sided Stellate Ganglion Block for Treatment of Posttraumatic Stress Disorder Symptoms - Acceptability

RTI International3 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2017年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
3
主要终点
Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of service members or service member/spouse couples.

研究概览

简要总结

This qualitative study will use focus groups, small group interviews, and individual interviews (both in person and over the phone) to compile a range of perspectives on service members' decision-making processes and information needs related to Stellate Ganglion Block (SGB). Participants will include service members, spouses, and providers.

详细描述

The qualitative (acceptability) study will use focus groups, small group interviews, and individual interviews (both in person and telephonic) to compile a range of perspectives on service members' decision-making processes and information needs related to SGB. Participants will include service members, spouses, and providers. Data collection will occur at each study site because attitudes conveyed by leadership and chain of command may vary across installation. Scheduling will be based on the accumulation of ample service members indicating an interest in participating.

All service members enrolled in the clinical effectiveness trial (Study Number: NCT03077919) will be eligible for the qualitative study if they have received at least one SGB study procedure during the three months prior to qualitative data collection. When qualitative data collection is scheduled, the study team will approach service members who indicated initial interest in participating in the acceptability if they still meet the eligibility criteria. Service members will not be contacted for qualitative study participation if the Research Coordinator or treating provider considers that participation would cause undue distress based on their most recent contact with the individual.

Service members who did not participate in the clinical effectiveness trial are eligible for the qualitative study if they have received at least one SGB for PTSD symptoms at a study site in the three months prior to qualitative data collection and if participation would not cause undue distress. These participants will be recruited in the clinic as well as through a medical record search conducted by the Site PI or other clinical staff.

Assignment to specific focus groups will be based on pay grade and subjective assessment of change as reported at the 4-Week assessment or at the time of screening for the qualitative study. In order to maximize homogeneity, lower enlisted service members and non-commissioned officers (NCOs) will be assigned to different groups. These groups will be further divided so that those reporting positive change since the procedure will be assigned to a different group than those reporting no change or feeling worse than at the time of the procedure. Depending on the number of eligible participants by pay grade, officers may be interviewed individually.

Eligible service members, both clinical trial and non-clinical trial participants, may be assigned to a service member/spouse dyad subgroup if they meet the above criteria and their spouse has expressed an interest in participating in the qualitative study. Those service members who participate as part of the dyad subgroup will not be eligible to participate in the service member only focus groups.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Service members will be excluded from the qualitative study if participation would cause them undue distress, in the opinion of the RC or treating clinician.

结局指标

主要结局

Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of service members or service member/spouse couples.

时间窗: Within three month of receiving one SGB study procedure for PTSD symptoms

Discussion topic areas: * Context for mental health and treatment * Advantages and drawbacks of treatment options * Information and decision-making * Experience and expectations

Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of providers

时间窗: Through study completion, approximately six months

Discussion topic areas: * Context for mental health and treatment * Advantages and drawbacks of treatment options * Information and decision-making * Experience and expectations

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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