Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Change in Moral Injury and Distress Scale
研究概览
简要总结
Moral Injury Syndrome (MIS) affects up to 35-60% of Veterans managing combat-related PTSD; it results from experiences that challenge deeply held values or spiritual beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of spiritual beliefs, difficulty with forgiveness, loss of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger.
Veterans managing MIS have difficulty responding to mental health treatment, and are at increased risk for suicide ideation or attempts. To date evidence-based interventions for MIS are not widely available in VA. This study will implement an evidence-based intervention for MIS in four VA facilities, collect data on the effectiveness of the intervention, and develop an implementation toolkit. This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service.
详细描述
Background: Moral injury syndrome (MIS) consists of the psychological and behavioral sequelae of experiences that challenge moral, spiritual, or values related beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of previously held spiritual beliefs, struggle with a Higher Power, difficulty with forgiveness, lack of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide, and derive less benefit from psychotherapy. There are few evidence-based interventions for moral injury; one such intervention is a manualized, group intervention called "Building Spiritual Strength (BSS)." In previous randomized controlled trials BSS has been shown to reduce both symptoms of PTSD and spiritual distress.
This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome. Hypotheses are:
- Compared to Present Centered Group Therapy (PCGT), BSS will significantly decrease symptoms of MIS.
- Compared to PCGT, BSS will significantly decrease symptoms of PTSD, depression, and suicidal ideation.
Significance: To date there are not standard procedures for assessing and treating MIS, so it is likely that untreated MIS is contributing to poor outcomes, including suicides. Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans' mental health.
Innovation and Impact: To date there have not been funded implementation studies on treatments for MIS in Veterans, and very few VA facilities provide evidence-based care for MIS. This study can clear the way to make evidence-based care for MIS more accessible in the VA system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will not have access to shared files, and will not be at any team meetings in which individual participants are discussed, so she will not know to what condition the participants have been assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran status and:
- •(a) validation of any of the first three items on the Moral Injury and Distress Scale, which is consistent with probable MIS
- •(b) willingness to be randomized to either treatment condition
- •(c) stability on mental health medications for at least 8 weeks
- •(d) age of 18 years or older
排除标准
- •(a) insufficient capacity to consent
- •(b) active psychosis or substance use at levels that would interfere with treatment, assessed via chart review, the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) score, and the Mini International Neuropsychiatric Interview (MINI)
- •(c) currently involved in evidence-based psychotherapy for MIS, or evidence-based psychotherapy for PTSD, assessed via chart review and intake interview
- •(d) managing any severe psychopathology that, in the opinion of the investigative team, requires immediate clinical attention, such as imminent suicide risk, assessed via the MINI and supplemental homicide risk questions.
研究组 & 干预措施
Building Spiritual Strength
Spiritually integrated group intervention for moral injury.
干预措施: Building Spiritual Strength (Behavioral)
Present Centered Group Therapy
Coping strategies group intervention addressing broad spectrum trauma symptoms
干预措施: Present Centered Group Therapy (Behavioral)
结局指标
主要结局
Change in Moral Injury and Distress Scale
时间窗: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Full Scale Name: Moral Injury and Distress Scale Score Range: 0-90, with higher scores indicating more symptoms.
Change in Moral Injury Outcomes Scale
时间窗: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Full Scale Name: Moral Injury and Distress Scale Score Range: 0-56, with higher scores indicating more symptoms.
Change in Religious and Spiritual Struggles Scale
时间窗: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Full Scale Name: Religions and Spiritual Struggles Scale Score Range: 0=4 with higher scores indicating more symptoms
次要结局
- Change in Sheehan Disability Scale(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- Change in Patient Health Questionnaire-9(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- Change in Beck Scale for Suicide Ideation(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- Change in Reasons for Living Inventory(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- PTSD Checklist for DSM-5(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- Psychospiritual Development Scale(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- Spiritual Fortitude Questionnaire(8 weeks (end of treatment) and 20 weeks (long-term follow-up))
- Client Satisfaction Questionnaire-8(8 weeks (end of treatment))