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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
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.
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 and Building Spiritual Strength. However, these comparison conditions focused on the treatment of PTSD rather than moral injury. The proposed PCT-MI comparison condition has been adapted to focus specifically on moral injury. PCT-MI includes psychoeducation about moral injury and related problems and individual case conceptualization sessions that are theoretically coherent with the process-based framework and nonspecific therapeutic factors central to PCT and present in most psychotherapies.
Rocky Mountain VA Regional Medical Center
Aurora, Colorado, United States
Change from Baseline to post-treatment on Outcome Questionnaire - 45.2
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.
Time frame: Baseline, within 1 week post-treatment completion
Change from Baseline on Outcome Questionnaire - 45.2 to (a) one- and (b) three-months post-treatment
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.
Time frame: Baseline, 1-month follow up, 3-months follow up
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