Reconsolidation of Traumatic Memories (RTM) for Moral Injury

Phase-Based Estimates
1
Effectiveness
2
Safety
Uniformed Services University of Health Sciences (USUHS), Bethesda, MD
Moral Injury+6 More
Reconsolidation of Traumatic Memories (RTM) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Moral Injury

Study Summary

RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

See full description

Eligible Conditions

  • Moral Injury
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic
  • Brain Injuries
  • Brain Injuries, Traumatic
  • Disease
  • Traumatic Brain Injury (TBI)
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Reconsolidation of Traumatic Memories (RTM) will improve 1 primary outcome, 5 secondary outcomes, and 4 other outcomes in patients with Moral Injury. Measurement will happen over the course of week 10, compared to baseline.

week 10
Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)
Month 12
Change in Neurobehavioral Symptom Inventory (NSI) Score
Change in PTSD Checklist for DSM5 (PCL5) Score
Change in Patient Health Questionnaire (PHQ-9) Score
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Change in World Health Organization Quality of Life Inventory (WHOQOL-100) Score
Week 10
Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score
Change in plasma interleukin-10 level
Change in plasma interleukin-6 level
Change in plasma tumor necrosis factor-alpha level

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Prolonged Exposure (PE)
Reconsolidation of Traumatic Memories (RTM)

This trial requires 108 total participants across 2 different treatment groups

This trial involves 2 different treatments. Reconsolidation Of Traumatic Memories (RTM) 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 2 & 3 and have had some early promising results.

Reconsolidation of Traumatic Memories (RTM)
Behavioral
Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. RTM will follow a manual developed by the Research and Recognition Project, who will also train and supervise the therapists. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 <34, can decide with their therapist whether early cessation of therapy is appropriate.
Prolonged Exposure (PE)
Behavioral
Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. PE will follow a manual written by the Foa and colleagues, and the therapists will be trained by expert trainers from the Center for Deployment Psychology. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 <34, can decide with their therapist whether early cessation of therapy is appropriate.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 10, and 2, 6 and 12 months later, compared to baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 10, and 2, 6 and 12 months later, compared to baseline for reporting.

Closest Location

Uniformed Services University of Health Sciences (USUHS) - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Meets criteria for PTSD on the CAPS5, with past month nightmares or flashbacks.
Willing to be randomly assigned to one of the two interventions and to complete all study measures.
Able to exhibit capacity to understand the informed consent process, by completion of a corresponding series of questions

Patient Q&A Section

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

Can moral injury be cured?

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Moral injury can be removed through a proper process of healing, but the process of healing always takes time and there is no guarantee that the process will succeed and that the person who has experienced it will not come back with a new moral injury.

Unverified Answer

What is moral injury?

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Moral injury is the process in which people who witness others suffer, perceive others suffer, or learn about others suffer, experience great pain or suffer great fear as a result, suffer from feelings of guilt or remorse, doubt, distress and shame, or suffer from post-traumatic distress. Moral injury occurs when people feel that their actions are insufficiently acceptable, inappropriate, or just are morally incongruent, and it causes distress and shame. It tends to cause people to withdraw from the actions they took. For example, they want to say they are sorry to someone with whom they have worked. However, people may be unaware of their guilt or embarrassment about what they have been feeling about the person they are saying thanks to.

Unverified Answer

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

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Moral injury is significantly prevalent in the United States; at least 1.2% of the U.S population experienced some form of moral injury over a year. In comparison to similar studies in the United Kingdom and Australia, moral injury is more likely to be experienced by men, the less educated, those in the lower socio-economic status, and in the workplace; and by Christians, particularly Catholics and Methodists.

Unverified Answer

What are common treatments for moral injury?

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Moleshed, a treatment for moral injury, was frequently self-medicated by patients, who typically felt better after the procedure. The procedure could be considered as a first step in the development of an effective moral injury management program for clinical psychiatric settings.

Unverified Answer

What causes moral injury?

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In all three types of crimes, an offender used violence to intimidate the public before committing the crime. The offender's motive may include a sense of pride or shame. A community with a high level of social order may be more susceptible to moral injury because of its ability to deter violent behavior.

Unverified Answer

What are the signs of moral injury?

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Moral injury is a new concept and requires further study to be fully understood. Data from a recent study shows the need for a public health approach to the prevention of moral injury.

Unverified Answer

Is reconsolidation of traumatic memories (rtm) typically used in combination with any other treatments?

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rtm could significantly reduce the intensity of traumatic memories with very minimal side effects, with the exception of stress levels. The combination of rtm and exposure therapy was found to reduce the intensity of traumatic memories especially when there were other types of trauma.

Unverified Answer

How does reconsolidation of traumatic memories (rtm) work?

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There is a period of rtm consolidation that follows exposure to traumatic stimuli in animal paradigms of post-traumatic memory consolidation. The question remains how rtm consolidation may function to influence post-traumatic symptomatology. Recent research suggests that rtm consolidation may be essential for maintenance of post-traumatic stress symptoms. There is therefore a strong clinical relevance to understand what constitutes a satisfactory 'therapeutic window' (twee) for rtm consolidation.

Unverified Answer

Does moral injury run in families?

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Moral injury seems common in this sample, yet as a type of traumatic stress is often overlooked and underdiagnosed, our findings underscore the need to consider moral injury as a potential component of trauma assessment and treatment, especially in familial settings and to the extent this is ignored the risks for impaired psychological and physical health and wellbeing.

Unverified Answer

Have there been any new discoveries for treating moral injury?

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A new concept for treating moral injury has been introduced by applying the notion of medical ethics as a clinical science, which brings together research findings from other medical fields. Future studies are needed to examine clinical manifestations and determinants of moral injury.

Unverified Answer

What is reconsolidation of traumatic memories (rtm)?

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rtm can be defined as the retrieval of a previously encoded traumatic memory in the service of trauma-related motivation, and it can have a powerful influence on the person's psychological well-being. To a small degree, this phenomenon occurs every day. Unfortunately, there are often various risks and hazards involved in the process, including emotional distress and the introduction of untoward outcomes. rtm was originally designed to investigate a potential treatment intervention for posttraumatic stress disorder (PTSD), but this particular intervention has since been integrated into various other treatments for a wide spectrum of psychological disorders and psychiatric disorders.

Unverified Answer

Does reconsolidation of traumatic memories (rtm) improve quality of life for those with moral injury?

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The incorporation of a single-session rtm paradigm in an established treatment protocol for MII patients was effective in inducing long-term and maintenance memory reconsolidation. Participants who had presented with traumatic memories reported significant improvement in QoL over time.

Unverified Answer
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