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临床试验/NCT06723834
NCT06723834Enrolling By Invitation不适用

Psychiatric Service Dogs and Prolonged Exposure Therapy for Military-Connected PTSD: A Randomized Clinical Trial

University of Arizona1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
216
试验地点
1
主要终点
PTSD Symptom Severity (Self-report)

研究概览

简要总结

This study investigates the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy. We will learn whether Service Dog partnership in combination with Prolonged Exposure Therapy treatment can help Veterans with PTSD.

详细描述

Posttraumatic stress disorder (PTSD) is common among military Service Members and Veterans (hereafter, "Veterans"). Symptoms of flashbacks, nightmares, and panic attacks can have devastating impacts on Veterans and their families. Suicide and suicidality are also closely linked to PTSD, and the rate of death by suicide among Veterans is nearly double that of the civilian population. PTSD is also difficult to treat. Many Veterans either do not seek treatment at all, or if they start treatment, do not finish. Even if treatment is completed, many Veterans still suffer symptoms and even retain their PTSD diagnosis. There is a critical need to find ways to reduce dropout rates, thus improving the effectiveness of existing, gold-standard treatments and promoting positive outcomes for Veterans and their families.

In their search for effective treatments, some Veterans are turning to add-on interventions for PTSD, such as partnership with a Service Dog. Under the Americans with Disabilities Act (ADA), service dogs are defined as dogs trained to perform specific tasks to mitigate a disability. Service dogs for PTSD are trained in tasks including detecting and alerting to signs of distress to interrupt anxiety and panic attacks and retrieving medication. In addition to trained tasks, service dogs live with the Veterans to provide emotional value as a source of comfort and companionship. Under the ADA guidance, Veterans with PTSD have the legal right to be accompanied by their service dog in public places such as grocery stores, workplaces, and schools. In this study, service dogs will be sourced from participating service dog organizations.

Service Dogs for Veterans are not only increasingly in demand, but a growing body of evidence demonstrates that Service Dogs can significantly improve the lives of Veterans with PTSD. Unfortunately, there is currently no research exploring whether adding a Service Dog will impact the effectiveness of evidence-based PTSD treatments, such as Prolonged Exposure Therapy (PE). Prolonged Exposure Therapy is a gold-standard, frontline treatment for PTSD that is highly effective, but has high rates of dropout.

PE teaches individuals with PTSD to gradually approach trauma-related memories, feelings, and situations that they have been avoiding since their trauma. By confronting these challenges, participants can decrease their PTSD symptoms. PE treatment typically last 12 weeks for 75-90 minutes, once per week.

Initial findings suggest that Service Dogs may help Veterans stay in Prolonged Exposure Therapy resulting in better treatment outcomes. However, some mental health professionals worry that Service Dogs may in fact interfere with treatment goals. This novel study is designed to help understand the impact of Service Dog partnership on the effectiveness of Prolonged Exposure Therapy.

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

(Secondary outcome) PTSD Severity and symptoms via blinded clinician rating, employing the Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5-R, Range 0-80, Lower scores indicate a better outcome)

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

  • Applied for and approved to receive a psychiatric service dog from a service dog organization participating in the study
  • Diagnosis of PTSD on the CAPS-5-R

排除标准

  • Current service dog
  • Current participation in Prolonged Exposure Therapy

研究组 & 干预措施

Prolonged Exposure Therapy Alone

Active Comparator

Participants will receive 12 weeks of Prolonged Exposure once per week

干预措施: Prolonged Exposure Therapy (Behavioral)

PTSD Service Dog + Prolonged Exposure Therapy

Experimental

Participants will receive 12 weeks of Prolonged Exposure once per week with the addition of a service dog

干预措施: Psychiatric Service Dog (Other)

PTSD Service Dog + Prolonged Exposure Therapy

Experimental

Participants will receive 12 weeks of Prolonged Exposure once per week with the addition of a service dog

干预措施: Prolonged Exposure Therapy (Behavioral)

结局指标

主要结局

PTSD Symptom Severity (Self-report)

时间窗: 3 months after start of PE

PTSD Checklist for DSM-5 (PCL-5) Total Score; range 0-80; higher scores indicate worse outcome.

次要结局

  • Depression(3 months after start of PE)
  • Anxiety(3 months after start of PE)
  • Emotional affect(3 months after start of PE)
  • Satisfaction with life(3 months after start of PE)
  • Mental health(3 months after start of PE)
  • PTSD Symptom Severity (Clinician-assessed)(3 months after start of PE)
  • PTSD Diagnosis(3 months after start of PE)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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