Moral InjuryNCT07710521
Comparing Two Moral Injury Treatments
A study testing Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI) in people with Moral Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Moral Injury
- What is being tested?
- Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2026to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rocky Mountain VA Regional Medical Center
Aurora, Colorado, 80045
About this study
Official title: Comparing Two Moral Injury Treatments: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury
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.
Read more
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.
Read the detailed description
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.
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).
- Conditions
- Moral Injury
- Being tested
- Acceptance and Commitment Therapy for Moral Injury (ACT-MI), Present Centered Therapy for Moral Injury (PCT-MI)
- Keywords
- moral injury, acceptance and commitment therapy for moral injury (ACT-MI), present centered therapy for moral injury (PCT-MI), Veteran, psychosocial functioning
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)Behavioural
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.
Present Centered Therapy for Moral Injury (PCT-MI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT-MI | Experimental | Acceptant and Commitment Therapy for Moral Injury Receives: Behavioral: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) |
| PCT-MI | Active comparator | Present Centered Therapy for Moral Injury Receives: Behavioral: Present Centered Therapy for Moral Injury (PCT-MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, within 1 week post-treatment completion
Secondary outcomes (1)
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.
Measured: Baseline, 1-month follow up, 3-months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start28 Sep 2026
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (78)Papers the sponsor has linked to this study.
- Other trials for Moral InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to Acceptance and Commitment Therapy for Moral Injury (ACT-MI) or Present Centered Therapy for Moral Injury (PCT-MI)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Denver Research Institute, Northern California Institute of Research and Education, Henry M. Jackson Foundation for the Advancement of Military Medicine, Palo Alto Veterans Institute for Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710521
- Sponsor's protocol ID
- COMIRB 25-2255
- Other IDs
- HT94252510981
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A final Limited Data Set will be made available, in accordance with VA policy and regulations and per compliance with current IRB and VA R\&D approvals in place for this project. A study-specific DUA will be required. Data requests must be made in writing. Requests for access to data obtained from this project will be considered and responded to. Data will be provided electronically, only with a DUA in place, and per VA regulations for transferring data.
Publications
Todd DM, Deane FP, Bragdon RA. Client and therapist reasons for termination: a conceptualization and preliminary validation. J Clin Psychol. 2003 Jan;59(1):133-47. doi: 10.1002/jclp.10123.
PubMed 1250833780. Hasson-Ohayon I, Roe D, Kravetz, S. A qualitative approach to the evaluation of psychosocial interventions for persons with severe mental illness. Psychological Services. 2006;3(4):262-273.
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.
PubMed 3476761778. 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
Jensen AC, Amundson EC, Brown C, Cochrane J, Daly D, Glenn R, Hope K, Hawkins J, Oakley JW, Sacra E, Walker J, Westmoreland WC Sr. "Not all groups come together, but this one just clicks": Ten Tips for Sustaining an Engagement Panel. J Gen Intern Med. 2022 Apr;37(Suppl 1):80-82. doi: 10.1007/s11606-021-06985-1. Epub 2022 Mar 29.
PubMed 35349020Borges 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.
PubMed 35756696Palmer BW, Dunn LB, Appelbaum PS, Mudaliar S, Thal L, Henry R, Golshan S, Jeste DV. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry. 2005 Jul;62(7):726-33. doi: 10.1001/archpsyc.62.7.726.
PubMed 15997013Taub 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.
PubMed 23520237Forster JE, MaWhinney S, Ball EL, Fairclough D. A varying-coefficient method for analyzing longitudinal clinical trials data with nonignorable dropout. Contemp Clin Trials. 2012 Mar;33(2):378-85. doi: 10.1016/j.cct.2011.11.009. Epub 2011 Nov 12.
PubMed 22101223Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med. 2012 Feb 20;31(4):328-40. doi: 10.1002/sim.4431. Epub 2011 Dec 4.
PubMed 22139891Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19-26. doi: 10.1016/s0895-4356(98)00138-3.
PubMed 9973070Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC Med Res Methodol. 2014 Feb 10;14:20. doi: 10.1186/1471-2288-14-20.
PubMed 24512175Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5.
PubMed 34215286Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018 Oct 8;8(10):e019993. doi: 10.1136/bmjopen-2017-019993.
PubMed 30297341Vindrola-Padros C, Johnson GA. Rapid Techniques in Qualitative Research: A Critical Review of the Literature. Qual Health Res. 2020 Aug;30(10):1596-1604. doi: 10.1177/1049732320921835.
PubMed 32667277
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Moral Injury Treatments: Acceptance and Commitment Therapy for Moral Injury and Present Centered Therapy for Moral Injury
- ClinicalTrials.gov ID
- NCT07710521
- Acronym / sponsor ID
- COMIRB 25-2255
- Conditions
- Moral Injury
- Keywords
- moral injury, acceptance and commitment therapy for moral injury (ACT-MI), present centered therapy for moral injury (PCT-MI), Veteran, psychosocial functioning
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- Denver Research Institute, Northern California Institute of Research and Education, Henry M. Jackson Foundation for the Advancement of Military Medicine, Palo Alto Veterans Institute for Research
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to Acceptance and Commitment Therapy for Moral Injury (ACT-MI) or Present Centered Therapy for Moral Injury (PCT-MI)
| Arm | Type | Receives |
|---|---|---|
| ACT-MI | Experimental | Behavioral: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)Acceptant and Commitment Therapy for Moral Injury |
| PCT-MI | Active comparator | Behavioral: Present Centered Therapy for Moral Injury (PCT-MI)Present Centered Therapy for Moral Injury |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ACT-MI |
| 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 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. | Behavioural | PCT-MI |
Primary outcome
Change from Baseline to post-treatment on Outcome Questionnaire - 45.2
Time frame: 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.
1 secondary outcome
Change from Baseline on Outcome Questionnaire - 45.2 to (a) one- and (b) three-months post-treatment
Time frame: Baseline, 1-month follow up, 3-months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 12508337Todd DM, Deane FP, Bragdon RA. Client and therapist reasons for termination: a conceptualization and preliminary validation. J Clin Psychol. 2003 Jan;59(1):133-47. doi: 10.1002/jclp.10123.
- Background80. Hasson-Ohayon I, Roe D, Kravetz, S. A qualitative approach to the evaluation of psychosocial interventions for persons with severe mental illness. Psychological Services. 2006;3(4):262-273.
- Background: PubMed 34767617Borges 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.
- Background78. 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
- Background: PubMed 35349020Jensen AC, Amundson EC, Brown C, Cochrane J, Daly D, Glenn R, Hope K, Hawkins J, Oakley JW, Sacra E, Walker J, Westmoreland WC Sr. "Not all groups come together, but this one just clicks": Ten Tips for Sustaining an Engagement Panel. J Gen Intern Med. 2022 Apr;37(Suppl 1):80-82. doi: 10.1007/s11606-021-06985-1. Epub 2022 Mar 29.
- Background: PubMed 35756696Borges 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.
- Background: PubMed 15997013Palmer BW, Dunn LB, Appelbaum PS, Mudaliar S, Thal L, Henry R, Golshan S, Jeste DV. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry. 2005 Jul;62(7):726-33. doi: 10.1001/archpsyc.62.7.726.
- Background: PubMed 23520237Taub 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.
- Background: PubMed 22101223Forster JE, MaWhinney S, Ball EL, Fairclough D. A varying-coefficient method for analyzing longitudinal clinical trials data with nonignorable dropout. Contemp Clin Trials. 2012 Mar;33(2):378-85. doi: 10.1016/j.cct.2011.11.009. Epub 2011 Nov 12.
- Background: PubMed 22139891Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med. 2012 Feb 20;31(4):328-40. doi: 10.1002/sim.4431. Epub 2011 Dec 4.
- Background: PubMed 9973070Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19-26. doi: 10.1016/s0895-4356(98)00138-3.
- Background: PubMed 24512175Kahan BC. Accounting for centre-effects in multicentre trials with a binary outcome - when, why, and how? BMC Med Res Methodol. 2014 Feb 10;14:20. doi: 10.1186/1471-2288-14-20.
- Individual participant dataSharing planned: Yes. A final Limited Data Set will be made available, in accordance with VA policy and regulations and per compliance with current IRB and VA R\&D approvals in place for this project. A study-specific DUA will be required. Data requests must be made in writing. Requests for access to data obtained from this project will be considered and responded to. Data will be provided electronically, only with a DUA in place, and per VA regulations for transferring data.
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Moral Injury, Moral Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI) in people with Moral Injury, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to post-treatment on Outcome Questionnaire - 45.2 (time frame: Baseline, within 1 week post-treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07710521, which also lists 78 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.