Comparing Two Moral Injury Treatments

Официальное название

Comparing Two Moral Injury Treatments: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury

Обзор

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: 1. Determine the efficacy of ACT-MI for building functional recovery among 180 warzone deployed Veterans. 2. 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.

Подробное описание

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:

1. 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. 2. 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.

At the end of the initial assessment session participants will be randomly assigned to participate in one of the two treatments: (1) ACT for Moral Injury or (2) Present Centered Therapy for Moral Injury. Randomization is a method that is similar to tossing a coin. Treatment groups will be held online using videoconferencing. Treatment groups will be small, consisting of about 8 Veterans in each cohort who also experience moral injury.

The participants in both Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury will meet in a therapy group through videoconferencing over 15- weeks. Both treatments will include 12 90-minute group therapy sessions and 3 30-minute individual therapy sessions. Treatment will take place once a week.

At the end of the 15-weeks participants will be asked to participate in a post-treatment assessment session within one week of treatment completion. During which, participants will be asked questions about their experience of participating in treatment and complete some additional questionnaires. Participants will also complete a qualitative interview about their experience of treatment, and their responses will be audio/video-recorded.

All participants will be asked to complete two additional follow-up assessment sessions (one month and three months after treatment) that can occur via phone or VA REDCap survey link. These surveys take approximately one hour.

This research study is expected to take approximately 4 years. Individual participation in the project will take around 7.5 months (around 4 and a half months of treatment and 3 additional months for follow-up assessment sessions).

Вмешательства

• Поведенческое Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
  ACT-MI is a 15-week hybrid group (12, 90-minute group sessions) and individual (3, 30-minute case conceptualization sessions) psychotherapy offered over telehealth. The primary goal of the clinician delivering ACT-MI is to help individuals impacted by moral injury live meaningful lives even in the presence of moral pain. This means learning to experience moral pain and connecting with values simultaneously.
• Поведенческое Present Centered Therapy for Moral Injury (PCT-MI)
  PCT-MI is a 15-week hybrid group (12, 90-min sessions) and individual (3, 30-min sessions) psychotherapy offered over telehealth. PCT was developed as an active control in a PTSD Prolonged Exposure trial, including psychoeducation and problem-solving as the primary interventions. PCT has been used in multiple clinical trials as an active control condition for PTSD. Additionally, PCT has been used as a control condition in moral injury efficacy trials for interventions like Adaptive Disclosure an

Первичные конечные точки

• Change from Baseline to post-treatment on Outcome Questionnaire - 45.2 [Срок оценки: Baseline, within 1 week post-treatment completion]

Вторичные конечные точки (1)

• Change from Baseline on Outcome Questionnaire - 45.2 to (a) one- and (b) three-months post-treatment [Срок оценки: Baseline, 1-month follow up, 3-months follow up]

Критерии участия

Критерии включения

• Eligible for VHA care
• Age 18-89
• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rocky Mountain VA Regional Medical Center — Aurora

Публикации

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• Borges LM, Holliday R, Barnes SM, Bahraini NH, Kinney A, Forster JE, Brenner LA. A longitudinal analysis of the role of potentially morally injurious events on COVID-19-related psychosocial functioning among healthcare providers. PLoS One. 2021 Nov 12;16(11):e0260033. doi: 10.1371/journal.pone.0260033. eCollection 2021. PMID 34767617
• 78. Defense Health Agency. Defense Health Agency Strategic Research Plan: Psychological Health. February 2024. Accessed September 22, 2024. https://www.health.mil/Reference-Center/Publications/2024/04/25/DHA-SRP_Psychological_Health_508_Compliant
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• Borges LM, Desai A, Barnes SM, Johnson JPS. The Role of Social Determinants of Health in Moral Injury: Implications and Future Directions. Curr Treat Options Psychiatry. 2022;9(3):202-214. doi: 10.1007/s40501-022-00272-4. Epub 2022 Jun 20. PMID 35756696
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• Taub E, Uswatte G, Mark VW, Morris DM, Barman J, Bowman MH, Bryson C, Delgado A, Bishop-McKay S. Method for enhancing real-world use of a more affected arm in chronic stroke: transfer package of constraint-induced movement therapy. Stroke. 2013 May;44(5):1383-8. doi: 10.1161/STROKEAHA.111.000559. Epub 2013 Mar 21. PMID 23520237

Идентификаторы

NCT: NCT07710521 · COMIRB 25-2255 · HT94252510981

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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