跳至主要内容
临床试验/NCT05267665
NCT05267665招募中不适用

Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement

VA Office of Research and Development3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
3
主要终点
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

研究概览

简要总结

Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention.

Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.

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

Outcomes assessors are blind to the condition of the family member/Veteran

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

  • Inclusion criteria for Veterans will include:
  • a current DSM-5 diagnosis of PTSD
  • Veteran status
  • willing to have a family member involved in the study
  • has recently begun or is currently initiating individual CPT or PE (completed no more than 3 sessions of the protocol at the time of the baseline assessment)
  • If taking psychotropic medication, the Veteran must be on a stable dose for at least 30 days.
  • Inclusion criteria for family members will include:
  • age 18 or older, family member of the Veteran (significant other, parent, adult child, sibling, etc.)
  • currently having frequent contact with the Veteran (three or more times per week)

排除标准

  • Exclusion criteria for Veterans will include:
  • current engagement in couple/family treatment with the identified family member participant
  • current severe substance use disorder (mild/moderate use disorders will not be excluded; any level of nicotine or caffeine use disorder accepted)
  • current psychosis or unstable bipolar disorder diagnosis
  • high suicidal risk
  • significant cognitive impairment
  • Exclusion criteria for family members will include:
  • same as listed for Veterans. Additionally
  • family members will NOT be permitted to participate if they meet criteria for current PTSD

结局指标

主要结局

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

时间窗: Week 26

Severity of PTSD symptoms. Minimum score is 0 (best possible, no symptoms) and maximum score is 80 (worst possible, highest symptoms).

Adequate treatment dose

时间窗: Week 26

Categorical evaluation of whether the participant received 8 or more on-protocol sessions of CPT or PE during their 26-week study participation period. Possible scores are 0 (meaning \<8 sessions received; this is considered a poor outcome) or 1 (meaning 8 or more sessions received; this is considered a good outcome).

Treatment dropout

时间窗: Week 26

Categorical evaluation of whether the participant dropped out of treatment early. Possible scores are 0 (meaning participant did not drop out of treatment early; this is considered a good outcome) or 1 (meaning participant did drop out of treatment early; this is considered a poor outcome).

次要结局

  • Homework compliance(Week 26)
  • Quality of Life Inventory (QOLI)(Week 26)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (3)

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