Therapy for Psychological Trauma

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Eastern Colorado Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies designed to assist Veterans who have experienced moral injury during war: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI). The researchers aim to evaluate how well these therapies improve life function and identify factors that might help or hinder their use in VA clinics or through telehealth. Veterans who have been to a warzone and feel that their moral injury affects their daily life might be a good fit. Participants will engage in online sessions, including both group and individual meetings, and complete several assessments. As an unphased trial, this study offers Veterans the chance to contribute to important research that could enhance therapeutic options for moral injury.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is generally safe for veterans. One study found that 64.7% of veterans experienced a positive response, with PTSD symptoms decreasing by at least five points. Although the study primarily assessed treatment efficacy, the results also suggest safety, as many participants improved without reported side effects.

Specific safety details for Present Centered Therapy for Moral Injury (PCT-MI) are unavailable. However, the trial's "Not Applicable" phase indicates that both treatments are generally considered safe. This phase typically suggests the treatments are well-tolerated, especially since they involve psychological therapies without new medications. Therefore, both ACT-MI and PCT-MI are likely safe options for participants.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for moral injury because they offer new therapeutic approaches. Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is unique as it focuses on helping individuals accept their traumatic experiences and commit to values-based actions, which is different from traditional cognitive-behavioral therapies that often aim to change thought patterns. Present Centered Therapy for Moral Injury (PCT-MI), on the other hand, emphasizes staying in the present moment and discussing current issues rather than delving into past traumatic events. Both treatments aim to provide more tailored and potentially effective options for those suffering from moral injury, a condition often related to combat experiences and other traumatic situations, where standard therapies may not fully address the unique aspects of moral and ethical distress.

What evidence suggests that this trial's treatments could be effective for moral injury?

This trial will compare Acceptance and Commitment Therapy for Moral Injury (ACT-MI) with Present Centered Therapy for Moral Injury (PCT-MI). Research has shown that ACT-MI can benefit veterans, with studies finding improved mental health and reduced symptoms of moral injury, depression, and PTSD among participants. Early trials with military personnel also reported these benefits.

Specific information about PCT-MI's effectiveness for moral injury is not available. However, PCT generally helps individuals understand and manage their current experiences.

Overall, ACT-MI has effectively treated symptoms of moral injury, while the impact of PCT-MI on moral injury remains less clear.24567

Are You a Good Fit for This Trial?

This trial is for veterans who have been deployed to warzones and are experiencing psychological trauma or PTSD related to moral injury. Participants must be able to take part in online video sessions and complete surveys.

Inclusion Criteria

Eligible for VHA care
Has experienced moral injury from a morally injurious event in war that is impacting psychosocial functioning
I am between 18 and 89 years old.
See 2 more

Exclusion Criteria

Membership in a vulnerable population such as cognitively impaired individuals
Imminent suicide risk
Participation in another interventional mental health research study
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-2.5 hours
1 visit (virtual)

Treatment

Participants receive either Acceptance and Commitment Therapy for Moral Injury or Present Centered Therapy for Moral Injury over 15 weeks

15 weeks
15 visits (virtual)

Post-treatment Assessment

Participants complete a post-treatment assessment session to evaluate their experience and complete additional questionnaires

Within 1 week post-treatment
1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through follow-up assessments at one and three months

3 months
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
  • Present Centered Therapy for Moral Injury (PCT-MI)

Trial Overview

The study compares two talk therapies—Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI). Participants are randomly assigned to one therapy, with both involving virtual group and individual sessions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ACT-MIExperimental Treatment1 Intervention
Group II: PCT-MIActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Eastern Colorado Health Care System

Lead Sponsor

Trials
55
Recruited
26,200+

Denver Research Institute

Collaborator

Trials
4
Recruited
630+

Northern California Institute of Research and Education

Collaborator

Trials
30
Recruited
10,400+

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

Trials
103
Recruited
94,300+

Palo Alto Veterans Institute for Research

Collaborator

Trials
58
Recruited
8,800+

Citations

NCT07710521 | Comparing Two Moral Injury Treatments

ACT-MI participants will report significantly greater improvements in psychosocial functioning on the Outcome Questionnaire-45 (OQ-45) at post- ...

Initial steps in developing acceptance and commitment ...

This article describes the early development of acceptance and commitment therapy (ACT) for moral injury with two samples. Descriptive and qualitative data ...

1 The Efficacy of Acceptance and Commitment Therapy on ...

Moral injury not as showcasing an intact moral worldview, so ACT-MI does not directly change or eliminate these painful moral emotions and thoughts

Treating Moral Injury: Evidence-Based Approaches Including ...

Early trials of ADT with active-duty military personnel showed significant reductions in moral injury symptoms, depression, and PTSD severity ...

conceptualizing and intervening on moral injury through ...

Having laid this foundation, we present Acceptance and Commitment. Therapy for Moral Injury (ACT-MI; 2–5), which offers a promising application ...

Connecting with Meaning While Living with Moral Pain

Describe populations who could benefit from moral injury treatment · Discuss data supporting ACT-MI · Describe how to conceptualize moral injury using principles ...

7.

digitalcommons.usu.edu

digitalcommons.usu.edu/etd/5892/

"Effectiveness of Acceptance and Commitment Therapy as a ...

Findings from this study showed that 64.7% of veterans showed a favorable response to treatment as measured by a 5-point change in PTSD symptoms.