Comparing Two Moral Injury Treatments: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from Baseline to post-treatment on Outcome Questionnaire - 45.2
研究概览
简要总结
Purpose of this study: The purpose of this study is to evaluate the effectiveness of two psychological treatments for moral injury: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury. The main questions it aims to answer are:
- Determine the efficacy of ACT-MI for building functional recovery among 180 warzone deployed Veterans.
- Identify barriers and facilitators to implementing ACT-MI in VA mental health clinics or a national telehealth hub in preparation for future dissemination efforts.
Participants will be asked to:
- Complete a two to two and a half hour initial assessment session online using videoconferencing. Participants will be asked to complete surveys and questionnaires.
- Be randomized to either ACT-MI or PCT-MI
- Meet with the study clinicians for 15 virtual outpatient sessions (12-group and 3-individual sessions).
- Complete a post-treatment assessment session offered online using videoconferencing within one week of treatment completion to complete surveys and questionnaires.
- Complete one- and three-month follow-up assessments offered online using videoconferencing to complete surveys and questionnaires.
详细描述
This study plans to learn more about two psychological treatments for moral injury: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury. These therapies are designed to help Veterans recover after their morals are violated in the warzone.
The main questions it aims to answer are:
- Determine the efficacy of ACT-MI for building functional recovery among 180 warzone deployed Veterans. Primary Hypothesis: The investigators hypothesize that ACT-MI participants will report significantly greater improvements in psychosocial functioning on the Outcome Questionnaire-45 (OQ-45) at post-treatment relative to pre-treatment compared to participants who receive PCT-MI. Secondary Hypothesis a and b: The investigators hypothesize that Veterans receiving ACT-MI will report significantly greater improvements in psychosocial functioning on the OQ-45 at (a) one- and (b) three-months post-treatment relative to pre-treatment compared to Veterans who receive PCT-MI.
- Identify barriers and facilitators to implementing ACT-MI in VA mental health clinics or a national telehealth hub in preparation for future dissemination efforts. The investigators' approach to identifying barriers and facilitators for future dissemination as well as informing ongoing decision making for the proposed trial involves community engagement at three levels including (1) development of a Veterans Engagement Group (VEG) to identify barriers and facilitators to recruitment and engagement of underrepresented Veterans, (2) facilitation of a VA Community Advisory Board (CAB) of VA mental health leadership to support recruitment, implementation, and dissemination efforts and, (3) conduct VA mental health provider focus groups for feedback on recruitment and engagement of Veterans and feedback on ACT-MI training materials.
Up to 436 people across the country will participate in the study.
Participants who join the study, will be asked to complete a two to two and a half hour initial assessment session online using videoconferencing and VA REDCap, in which the participants would answer questionnaires and interviews about mental health and mental health related behaviors.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Everyone except for the biostatistician will be blind to condition until randomization at the end of the pre-treatment assessment session. Outcome assessors will remain blind to condition for the duration of the study.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for VHA care
- •Has been deployed to a warzone
- •Has experienced moral injury from a morally injurious event in war that is impacting psychosocial functioning
- •Willing to be randomized to either of the two conditions (ACT-MI or PCT-MI)
排除标准
- •Inability to provide informed consent (operationalized as inability to answer 7 questions about the study and research participants' rights)
- •Inability to complete study measures (e.g., due to significant acute intoxication/withdrawal symptoms, mania, psychosis, aggression, catatonia, cognitive impairment)
- •Imminent suicide risk
- •Participation in another interventional mental health research study
- •Membership in a vulnerable population (e.g., cognitively impaired)
- •Current participation in an EBP for a condition related to moral injury
- •Past participation in ACT (based on medical record review and Veteran self-report)
结局指标
主要结局
Change from Baseline to post-treatment on Outcome Questionnaire - 45.2
时间窗: Baseline, within 1 week post-treatment completion
The Outcome Questionnaire-45.2 (OQ-45) is widely considered the gold standard of patient-reported outcome measures. Functioning is assessed within the last week across three psychosocial domains of symptom distress (e.g., "I feel nervous"), interpersonal relationships (e.g., "I have frequent arguments"), and social role functioning (e.g., "I find my work/school satisfying") on a scale of 0(Never) to 4(Always) generating a total score between 0 and 180. Higher scores denote greater psychological distress.
次要结局
- Change from Baseline on Outcome Questionnaire - 45.2 to (a) one- and (b) three-months post-treatment(Baseline, 1-month follow up, 3-months follow up)