Deep Brain Reorienting for Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Initial Assessment in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the CAPS-5
研究概览
简要总结
The goal of this clinical trial is to learn if Deep Brain Reorienting (DBR) works to treat posttraumatic stress disorder (PTSD) symptoms in military members and veterans. The main questions it aims to answer are:
- Does DBR lower PTSD symptoms compared with treatment as usual?
- Do PTSD symptoms stay lower three months after treatment?
Researchers will compare waitlist to see if DBR works to treat PTSD.
Participants will:
- Receive eight DBR sessions, each lasting about 50 minutes
- Answer questions before and after treatment and 3 months later
- Complete short questionnaires before and after each session
- Complete an interview about their experience of DBR
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stream 1: Military members and Veterans receiving the DBR Intervention:
- •Inclusion Criteria
- •18 to 65 years old
- •Current or former military member / Veteran (for Stream 1 only)
- •DSM-5 PTSD diagnosis determined via the CAPS-5
- •If on psychiatric medications: stable ≥ 4 weeks
- •Fluent in English
- •Ability to provide informed consent and participate in therapy sessions
- •Able to benefit from short-term therapy, as determined by study assessment
排除标准
- •High-risk clinical state (e.g., suicidal or homicidal intent; substance withdrawal) requiring acute intervention.
- •History of moderate to severe head or brain injury leading to impaired functioning (e.g., a Glasgow Coma Scale Score < 15 at the time of incident assessed retrospectively by participant; sustained loss of consciousness leading to impaired functioning)
- •Cognitive impairment limiting informed consent
- •Significant untreated medical illness
- •History of neurological disorder, pervasive developmental disorder, bipolar or psychotic disorder
- •Alcohol/substance use problems within the last 3 months requiring medical withdrawal or likely to interfere with therapy.
- •Degree of mental distress that is unlikely to benefit from a short-term therapy (for our participant's well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions).
- •Any condition that, in the clinical opinion of study psychiatrists or clinicians, would make psychotherapy ineffective or unsafe, or that would interfere with study engagement and completion (e.g., homeless, ongoing psychosocial crisis, etc).
- •Other considerations:
- •Participants will be asked not to start any new PTSD treatments (medications or psychotherapy) 4 weeks prior to study enrollment and until study participation is complete.
- •If already taking psychiatric medications, doses must be stable for at least 4 weeks prior to enrolling in the study, and remain stable until study completion.
- •Participants in DBR stream must be able and willing to pause other trauma-focused psychotherapies (e.g., CPT, EMDR, exposure therapy) while receiving DBR in the study. Non-trauma focused therapies (e.g. CBT) or supportive talk with a therapist may continue.
- •Stream 2: Civilian and other TAPs receiving the DBR Intervention:
- •Inclusion Criteria
- •≥ 18 years old
- •Trauma-related disorder, moral injury, another post-traumatic mental health condition (e.g., Post traumatic stress injury (PTSI)), or a mental health condition arising as a consequence of a trauma or extreme stress.
- •If on psychiatric medications: stable ≥ 4 weeks
- •Fluent in English
- •Ability to provide informed consent and participate in therapy sessions
- •Exclusion Criteria
- •Active psychosis or mania.
- •High-risk suicidal intent requiring acute intervention
- •Substance use disorder requiring medical withdrawal, or likely interfering with therapy engagement
- •Cognitive impairment limiting informed consent
- •Current participation in trauma-focused psychotherapy
- •Currently involved in litigation
- •The participant's condition is unlikely to benefit from short-term therapy. For our participant's well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions. It is likely that some potential participants will not be ready for trauma therapy.
- •Any condition that, in the clinical opinion of study psychiatrists or clinicians would make psychotherapy ineffective or unsafe, or that would interfere with study engagement and completion (e.g., homelessness, ongoing psychosocial crisis, etc).
- •Participants will be asked to refrain from starting any new treatment for PTSD until study participation is complete and pause other trauma-focused therapy.
- •Stream 3: Clinicians Receiving the DBR Training and Clinical Consultation:
- •Inclusion Criteria
- •Mental Health Clinicians licensed to provide psychotherapy interventions in Canada
- •Fluent in English
- •Willing to provide informed consent for the study procedures
- •Confidence and experience treating trauma and dissociation, including previous training in trauma-focused psychotherapies.
研究组 & 干预措施
Stream 1: Military Members and Veterans - DBR Group
Canadian Armed Forces members and Veterans randomized to receive eight weekly sessions of Deep Brain Reorienting (DBR).
干预措施: Deep Brain Reorienting (Behavioral)
Stream 2: Trauma-Affected Civilians - DBR
Trauma-affected civilian participants will receive eight sessions of DBR in an open-label study. Treatment may be extended to a maximum of 20 sessions when clinically indicated.
干预措施: Deep Brain Reorienting (Behavioral)
Stream 1: Military Members and Veterans - Waitlist/Treatment as Usual
Canadian Armed Forces members and Veterans randomized to continue treatment as usual during an eight-week waiting period. Following completion of the waitlist and follow-up assessments, eligible participants may be offered DBR.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Change From Initial Assessment in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the CAPS-5
时间窗: From initial assessment to post-treatment at 8 weeks and the 3-month follow-up
The Clinician-Administered PTSD Scale-5 (CAPS-5) is a clinician-rated measure of PTSD symptom severity. Each item is rated from 0 (absent) to 4 (extreme/incapacitating) and summed to produce a total score ranging from 0 to 80. Higher scores indicate more severe PTSD symptoms.
Change From Baseline in PTSD Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the PCL-5
时间窗: From baseline to post-treatment at 8 weeks and the 3-month follow-up
The PTSD Checklist for DSM-5 (PCL-5) is a self-reported measure of PTSD symptom severity. Each item is rated from 0 (not at all) to 4 (extremely). The total score ranges from 0 to 80, with higher scores indicating more severe PTSD symptoms.
Themes Related to Mental Health Professionals' Experiences of Learning Deep Brain Reorienting (DBR), as Identified Through Qualitative Interviews
时间窗: Post DBR training
Mental health professionals' experiences of learning DBR will be explored through qualitative interviews. This interview will take about 30 to 60 minutes. No numerical score will be generated.
次要结局
- Change from Baseline in Dissociation Symptoms at 8 Weeks and 3-Month Follow-Up as Assessed by the DES(From baseline to post-treatment at 8 weeks, and the 3-month follow-up)
- Change From Initial Assessment in Depression Symptom Severity at 8 Weeks and 3-Month Follow-Up as Assessed by the BDI-II(From initial assessment to post-treatment at 8 weeks and the 3-month follow-up)
- Change From Baseline in Trauma-related Shame at 8 Weeks and 3-Month Follow-Up as Assessed by the TRSI(From baseline to post-treatment at 8 weeks and the 3-month follow-up)
- Change From Baseline in Interoceptive Awareness at 8 Weeks and 3-Month Follow-Up as Assessed by the MAIA-Version 2(From baseline to post-treatment at 8 weeks and the 3-month follow-up)
- Change From Baseline in Physical Symptoms at 8 Weeks and 3-Month Follow-Up as Assessed by the PSS(From baseline to post-treatment at 8 weeks and the 3-month follow-up)
- Change From Baseline in Emotion Regulation at 8 Weeks and 3-Month Follow-Up as Assessed by the DERS-16(From baseline to post-treatment at 8 weeks and the 3-month follow-up)