CLINICAL TRIAL

Acceptance and Commitment Therapy for Moral Injury (ACT-MI) for Moral Injury

Refractory
Recruiting · 18+ · All Sexes · Aurora, CO

This study is evaluating whether a new treatment approach may help individuals with moral injury.

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About the trial for Moral Injury

Eligible Conditions
Stress Disorders, Post-Traumatic · Wounds and Injuries · Moral Injury

Treatment Groups

This trial involves 2 different treatments. Acceptance And Commitment Therapy For Moral Injury (ACT-MI) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Present Centered Therapy (PCT)
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
My life has been ruined by a morally injurious event that continues to bother me. show original
Eligible for VHA care
Has been deployed to a warzone
I am willing to be randomized into either of the two conditions. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
Screening: ~3 weeks
Treatment: Varies
Reporting: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Acceptance and Commitment Therapy for Moral Injury (ACT-MI) will improve 3 primary outcomes and 5 secondary outcomes in patients with Moral Injury. Measurement will happen over the course of Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up.

PROMIS Short Form v2.0-Satisfaction with Social Roles and Activities 8a
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT), POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION) AND 1- AND 3-MONTH FOLLOW-UP
This is a self-report measure that assesses ability to perform various social activities. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 8 to 40 points on this scale with higher scores associated with greater satisfaction with social roles and activities.
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT), POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION) AND 1- AND 3-MONTH FOLLOW-UP
Outcome Questionnaire-45 (OQ-45)
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT), POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION) AND 1- AND 3-MONTH FOLLOW-UP
The Outcome Questionnaire-45 (OQ-45) is a self-report measure that assesses functioning in the psychosocial domains of symptom distress (0-100 points), social relations (0-44 points), and social role functioning (0-36 points). The OQ-45 will be examined as a candidate outcome measure for a future efficacy trial. Higher scores on the OQ-45 are indicative of more symptom distress, difficulty in social relations, and difficulty in social role functioning.
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT), POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION) AND 1- AND 3-MONTH FOLLOW-UP
Valued Living Questionnaire
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT), POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION) AND 1- AND 3-MONTH FOLLOW-UP
The Valued Living Questionnaire is a self-report measure that assesses participants' values as well as the consistency with which they believe they have been living life according to their values. This scale will be examined as a candidate outcome measure for a future efficacy trial. A possible of 10 to 100 total points for importance of values and 10 to 100 total points for consistency of action with values is demonstrated on the Valued Living Questionnaire (VLQ). Higher scores on the VLQ are indicative of greater importance of values and greater consistency in acting on values.
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT), POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION) AND 1- AND 3-MONTH FOLLOW-UP
Reasons for Termination (Client and Therapist Versions)
POST-TREATMENT (0-7 DAYS AFTER TERMINATING TREATMENT)
The Reasons for Termination scale is a self-report measure which assesses the impact of common reasons patients terminate therapy. The scale will be used to assess treatment acceptability. Participants who terminate treatment early and their therapists will be asked to independently rate their reasons for termination in 19 domains. Possible total scores on this scale range from 10 to 190-points. Higher scores indicate that the reason for termination had a very great influence on the participant's termination of therapy.
POST-TREATMENT (0-7 DAYS AFTER TERMINATING TREATMENT)
Client Satisfaction Questionnaire
POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION)
The investigators will assess the proportion of participants who find ACT-MI acceptable, defined as 70% of participants scoring 24 on the Client Satisfaction Questionnaire (CSQ). The total for the CSQ can range from 8- to 32-points. Higher scores on the CSQ indicate greater treatment acceptability.
POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION)
Ecological Momentary Assessment
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT FOR A 1-WEEK PERIOD) AND POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION FOR A 1-WEEK PERIOD)
Self-report ecological momentary assessment via a smart phone application was developed to assess in the moment experiential avoidance (1 to 5 point rating for experiential avoidance during the assessment period [7 possible items with 2 to 3 administered during each assessment period], higher scores indicate more experiential avoidance), emotions (1 to 5 point rating for each emotion during the assessment period [13 possible items with 2 administered from each category-negative self-directed emotions, negative other-directed emotions, and positive emotions-during each assessment period], higher scores indicate feeling the emotion at an extreme level), and engagement in valued behavior (identify the number of domains from 0 to 10 areas in which they have engaged in the assessment period; qualitative information gathered via audio recording).
PRE-TREATMENT (UP TO 30-DAYS BEFORE STARTING TREATMENT FOR A 1-WEEK PERIOD) AND POST-TREATMENT (0-7 DAYS AFTER TREATMENT COMPLETION FOR A 1-WEEK PERIOD)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can moral injury be?

M&I is a significant health issue that may have severe consequences for health and for the family and the community. The effects of M&I are not limited to physical aspects only; they include mental distress, and the emotional consequences are often long-lasting.

Anonymous Patient Answer

What causes moral injury?

moral injury is caused primarily by moral dilemmas, which involve decisions about values, justice, and fairness, as well as moral virtues. moral injury represents a form of moral distress and is distinct from suicide, which is a choice rather than a response. Results from a recent clinical trial from this study help to understand moral injury in adolescents in more detail and can inform future research into moral injury more broadly.

Anonymous Patient Answer

Can moral injury be cured?

Although this is a difficult study, it was possible to identify two main themes from the data. First, those people who were dissatisfied with the way the team treated them were less optimistic, and secondly, these people were more likely to feel responsible for their predicament. Both of these aspects reflect the 'cure' of the 'wrong' treatment by the 'right' treatment. It can be argued that a'moral injury' is a 'treatment' of itself.

Anonymous Patient Answer

What are common treatments for moral injury?

Recent findings found that one tenth of respondents were hospitalized and 9% had a prolonged hospital stay. Some treatments were frequently implemented, such as medication and intensive counseling.

Anonymous Patient Answer

What is moral injury?

There is, according to some, a need to discuss this term more widely as many professionals seem to use it to justify all sorts of 'bad work' whilst refusing to accept others are suffering similar harms, in effect using it to justify immoral conduct.

Anonymous Patient Answer

How many people get moral injury a year in the United States?

These data reveal that the proportion of civilians who are affected by a moral injury in a one-year period averages about 5%, even within major cities. The distribution of incidence among age groups, gender, and race/ethnicity are similar to data already compiled. This information is important because it highlights that the current distribution of public policy toward moral injury may not sufficiently serve the needs of all people.

Anonymous Patient Answer

What are the signs of moral injury?

The most common symptom of moral injury is anger. Other signs include guilt, shame, and loss of feeling. All of these signs of moral injury can be described by the term victimization. Moral injuries are common among those with and at risk for posttraumatic stress disorder. Moral injury in the context of posttraumatic stress disorder is not discussed in much detail in the research literature. Further research is needed to examine whether treating moral injury enhances recovery from posttraumatic stress disorder.

Anonymous Patient Answer

Who should consider clinical trials for moral injury?

Patients of varying demographics, ages, and abilities were found to be more open to clinical trials for moral injury and were more likely than controls to take time to discuss treatment options. Overall, patients were willing to try new drugs that had no previous record of effectiveness and did not consider themselves to be 'experts' about treatment. Therefore, clinicians can expect to recruit and incorporate patients and caregivers with varying knowledge and beliefs in treatment plans.

Anonymous Patient Answer

What are the latest developments in acceptance and commitment therapy for moral injury (act-mi) for therapeutic use?

ACT-M is a promising technique for use in therapeutic contexts. Results from a recent paper are in accordance with research showing that MT/M can have beneficial effects on multiple domains of functioning and that the core ACT-M principles apply across multiple domains of functioning. However, as the results suggest, ACT-M needs further development and testing in a more comprehensive clinical context.

Anonymous Patient Answer

What are the common side effects of acceptance and commitment therapy for moral injury (act-mi)?

ACBT can be highly effective in treating moral injury and should be considered for this patient population. Participants also reported various positive outcomes from the treatment process including, (a) improved moral functioning; (b) better relational functioning and interpersonal adjustment; (c) improved cognitive restructuring/thought-process skills; and (d) improvement in the treatment of suicidal ideation. The ACBT methodology used in this study lends itself well to being translated into a manual.

Anonymous Patient Answer

How does acceptance and commitment therapy for moral injury (act-mi) work?

Act-mi may decrease avoidance and improve coping, and may be useful in addressing guilt. Recent findings should be replicated in a randomized controlled design, with larger sample sizes, and using more diverse treatment samples.

Anonymous Patient Answer

Have there been any new discoveries for treating moral injury?

In a recent study, findings suggest that current interventions aimed at enhancing a person's moral development may actually be more effective when delivered at an earlier age. Moreover, these findings are the first indication that older adults can be effectively treated to reduce their moral injury.

Anonymous Patient Answer
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