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临床试验/NCT06019767
NCT06019767已完成不适用

Peer-led Trauma Therapy for Re-entry

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2023年11月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Feasibility: Compliance through participation

研究概览

简要总结

The purpose of the research is to learn more about how to treat PTSD for people directly impacted by incarceration (i.e., have spent time in prison or jail). This research will help identify if a PTSD treatment group that is used in community settings, and led by individuals with lived experience, is helpful in reducing PTSD symptoms among people who have been directly impacted by incarceration.

Participants will complete an interview to determine whether they are experiencing PTSD, and if so, will participate in a 6-week therapy group treatment.

详细描述

Two community Certified Peer Specialists (CPSs) who have experienced incarceration and re-entry from prison, and who have experienced trauma will be trained on delivering group Cognitive Processing Therapy (CPT).

Working with the Wisconsin Department of Health Services (DHS) and community organizations serving formerly incarcerated individuals, researchers will screen individuals for PTSD treatment need, and invite 48 eligible individuals to participate in group CPT co-led by one of the trained CPSs and a trained community therapist or provider.

Eligible participants who are enrolled in the study will be invited to complete a 6-week (12 sessions total) group CPT therapy treatment for PTSD. Participants will also complete pre-, mid-, and post-treatment mental health surveys. Participants will also complete a post-treatment focus group or post-treatment individual interview where they are asked about their experience in the therapy and to provide feedback on the study as a whole.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • 18 years of age or older
  • completed a prison or jail sentence
  • no current psychosis symptoms
  • no active self-harm or active suicidal intent
  • able and willing to participate in group therapy
  • meet criteria for PTSD treatment need

排除标准

  • current and active psychosis
  • current and active self-harm and suicidality
  • no PTSD diagnosis
  • current substance use dependence (not including those used as prescribed for medical reasons) on alcohol, cocaine, amphetamines, inhalants, sedatives or sleeping pills, hallucinogens, or opioids

研究组 & 干预措施

Cognitive Processing Therapy (CPT)

Experimental

Groups of 6-8 receive CPT to treat PTSD

干预措施: Cognitive Processing Therapy (Behavioral)

结局指标

主要结局

Feasibility: Compliance through participation

时间窗: Study duration (up to 2 years)

Will be measured by percentage of participants performing intervention activities during session, such as contributing to the discussion.

Ratings 1-7 by clinical supervisors on quality of session elements delivered by therapist

时间窗: Study duration (up to 2 years)

Higher ratings indicate higher-quality session element (scores 1-7; 1=not satisfactory, 4= satisfactory, 7=excellent) by the clinical supervisor. Assesses for therapist compliance as secondary measure of intervention efficacy.

Ratings from 0-5 by clinical supervisors on therapist adherence to five session elements

时间窗: Study duration (up to 2 years)

Higher ratings indicate better adherence to session elements. Assesses for therapist adherence to CPT guidelines as secondary measure of intervention efficacy.

Feasibility: Compliance through homework

时间窗: Study duration (up to 2 years)

Will be measured by percentage of participants completing homework assignments each week.

Feasibility: Rate of retention

时间窗: Study duration (up to 2 years)

Will be measured by percentage of participants who complete at least 9 of the 12 study sessions

Feasibility: Compliance through completing assessments

时间窗: Study duration (up to 2 years)

Will be measured by percentage of participants completing the pre-, mid-, and post-intervention assessment batteries.

Feasibility: Participation

时间窗: Study duration (up to 2 years)

Will be measured as the percentage of invited, eligible individuals who elect to participate.

Participant satisfaction

时间窗: One week post-treatment (up to 7 weeks)

Using the 8 item Client Satisfaction Questionnaire (CSQ-8), participants will rate their satisfaction with their experience. Scale ranges from 1-4, with total potential scores of 8 to 32 with higher scores indicating greater satisfaction.

Change in suicide and self-harm ideation

时间窗: Baseline to end of follow-up (up to 4.5 months)

Beck Depression Inventory-II (BDI-II), item 9. Participants will answer the item on a scale of 0-3, where a score of 2 or 3 indicates higher ideation.

Change in PTSD symptom severity

时间窗: Baseline to end of follow-up (up to 4.5 months)

Using the PTSD Checklist for DSM-5 (PCL-5), which is a 20-item self-report measure, symptoms of PTSD will be assessed. Participants will answer items on a scale of 0-4, where 0=Not at all and 4=Extremely. Higher scores indicate higher symptom severity.

次要结局

  • Change in trauma related thoughts and beliefs(Baseline to end of follow-up (up to 4.5 months))
  • Change in anxiety symptom severity(Baseline to end of follow-up (up to 4.5 months))
  • Change in depression symptom severity(Baseline to end of follow-up (up to 4.5 months))
  • Change in aspects of hopelessness(Baseline to end of follow-up (up to 4.5 months))
  • Change in substance use(Baseline to end of follow-up (up to 4.5 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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