CLINICAL TRIAL

Safety Aid Reduction Treatment for PTSD for Moral Injury

Waitlist Available · 18+ · All Sexes · New Orleans, LA

This study is evaluating whether a treatment program may help reduce symptoms of posttraumatic stress disorder.

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About the trial for Moral Injury

Eligible Conditions
Stress Disorders, Traumatic · Stress Disorders, Post-Traumatic

Treatment Groups

This trial involves 2 different treatments. Safety Aid Reduction Treatment For PTSD is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Safety Aid Reduction Treatment for PTSD
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Veterans who have been diagnosed with PTSD and decline trauma-focused treatment are more likely to experience negative consequences such as poorer physical health, increased drinking or drug use, and violence. show original
hospital speak out Veterans who are receiving care at the VA hospital in New Orleans are speaking out about the conditions there 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: Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, post-intervention or wait-list (10-weeks), and one-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 Safety Aid Reduction Treatment for PTSD will improve 4 primary outcomes and 4 secondary outcomes in patients with Moral Injury. Measurement will happen over the course of Post-intervention or wait-list (10-weeks).

Client Satisfaction Questionnaire-8 (CSQ-8)
POST-INTERVENTION OR WAIT-LIST (10-WEEKS)
The CSQ-8 is an 8-item self-report questionnaire designed to assess overall satisfaction with treatment services. Although response options differ from item-to-item, all questions are rated on a 4-point Likert-type scale ranging from 1 to 4 with higher scores indicating higher treatment satisfaction. The CSQ-8 will be administered immediately following the 10-week group or wait-list period to assess treatment acceptability.
POST-INTERVENTION OR WAIT-LIST (10-WEEKS)
Changes in safety aid usage as measured by the Safety Behavior Assessment Form (SBAF)
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
The SBAF is a 41-item self-report questionnaire designed to assess safety behavior usage. Veterans will be asked to read a list of behaviors and rate how often they engage in each behavior using a 4-point Likert-type scale ranging from 0 (Never) to 3 (Always) with higher scores reflecting increased symptom severity. The SBAF will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in safety behavior usage.
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
Changes in anxiety as measured by the Beck Anxiety Inventory (BAI)
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
The BAI is a 21-item self-report questionnaire designed to assess the experience of anxiety symptoms. Veterans will be asked to rate how often they experience each symptom using a 4-point Likert-type scale ranging from 0 (Not at all) to 3 (Severely) with higher scores reflecting increased symptom severity. The BAI will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in anxiety symptoms.
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
Changes in funtional impairment as measured by the Sheehan Disability Scale (SDS)
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
The SDS is a 3-item self-report questionnaire designed to assess functional impairment functional impairment in work/school, social, and family life. For each domain, Veterans will be asked to provide an impairment rating ranging from 0 (Not at all) to 10 (Extremely) with higher scores reflecting increased impairment. The SDS will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in functional impairment.
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
The PCL-5 is a 20-item self-report questionnaire designed to assess each of the 20 DSM-5 PTSD symptoms. Veterans will be asked to read a list of symptoms and indicate their level of distress as it relates to each within the past month using a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores reflecting increased symptom severity. The PCL-5 will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in PTSD symptom severity.
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
Changes in PTSD cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
The PTCI is a 33-item self-report questionnaire designed to assess trauma-related thoughts and beliefs including negative cognitions regarding the self, others, and the world. Veterans will be asked to read a list of statements and indicate the degree to which they agree or disagree with each statement using a 7-point Likert-type scale ranging from 1(totally disagree) to 7 (totally agree) with higher scores reflecting increased symptom severity. The PTCI will be administered at baseline, immediately following the 10-week group or wait-list period, and at a one-month follow-up to assess changes in PTSD cognitions.
BASELINE, POST-INTERVENTION OR WAIT-LIST (10-WEEKS), AND ONE-MONTH FOLLOW-UP
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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 many people get moral injury a year in the United States?

Approximately 1.2 million Americans are injured by the actions or omissions of another person. The health care system's potential to treat those individuals is severely limited. Improving care for injured patients, both those injured by other people as well as by physical objects, could significantly improve both the quality of life for severely injured patients and the cost of their care.

Anonymous Patient Answer

What are common treatments for moral injury?

In a recent study, findings of this study suggest further research into the use of EMDR for the treatment of moral injury, and highlight the importance of helping patients understand and accept the severity and consequences of the event to help alleviate distress and promote resilience.

Anonymous Patient Answer

What are the signs of moral injury?

The patient usually shows the signs of moral injury because moral injury is a psychological emergency. Those who are more emotionally stable are more likely to demonstrate signs of moral injury as opposed to less psychologically stable persons. We have found that patients are willing to tell about moral injury if there were more effective ways available to communicate with such patients. Those who perceive their role as being fundamentally responsible and who believe that they could do more to help people in moral injury crisis derive higher levels of satisfaction from being honest in their communications. Patient empowerment is a significant factor in the success of communicating with someone in moral injury crisis.

Anonymous Patient Answer

Can moral injury be cured?

Moral injury cannot be cured. With treatment, many victims of moral injury can live a normal life. But the pain and grief from lost children and wives may be a persistent problem if moral injury is not treated.

Anonymous Patient Answer

What is moral injury?

A moral injury is a serious and persistent emotional, social or behavioral problem arising from a moral obligation or ethical commitment that exceeds the capacity of the subject to act on it. It is a profound emotional toll that most often ensues from attempting to uphold a moral code when it is impossible to fulfill it fully. Moral injury may lead to a loss of self-worth, reduced self-esteem and the perception of having lost a loved one, or a moral obligation, such as duty, that the subject cannot meet. Moral injuries are often characterized by extreme shame and/or remorse, loss of the sense of personal integrity or the desire to regain it, as well as feelings such as guilt, hopelessness, or despair.

Anonymous Patient Answer

What causes moral injury?

Moral injury is a more complex phenomenon than a simple shift from the good to the evil, but instead it's the perception that one can make a difference in the world by helping others. Those with a sense of responsibility and commitment to the world are most likely to experience moral injury.

Anonymous Patient Answer

How does safety aid reduction treatment for ptsd work?

These preliminary analyses suggest that the use of SAFER treatments and in particular SAFER PTSD is beneficial and deserves further investigation. The study is currently registered on clinicaltrials.gov as NCT02292594.

Anonymous Patient Answer

How serious can moral injury be?

Moral injury is associated with significant psychological harm. The study provides further evidence that psychological injury is serious enough to warrant an independent category in the International Classification of Diseases.

Anonymous Patient Answer

What are the common side effects of safety aid reduction treatment for ptsd?

Based on self-reported results, there were no statistically significant differences for the common side effects, except for itch. Because of the wide variety of side effects, it is essential to consider the benefits of using safety aid reduction when deciding whether to use safety aid reduction to treat PTSD.

Anonymous Patient Answer

Have there been any new discoveries for treating moral injury?

moral injury can be treated with several types of psychological therapies. In a meta-analysis study of four therapeutic trials, three used Cognitive Behavioral Therapy (CBT) and one used a Moral Skills Training (MST) approach. A meta-analysis of all four trials showed that the mean MST improvements in a moral injury group were consistently greater than those in a No Control Comparison (NC) group, and that the mean MST Improvement was consistently greater in every treatment group when compared to the NC group, [all four trials had at least one of the following: treatment effect > 2 SD and/or significant.comparison: NC > treatment group on at least one criterion].

Anonymous Patient Answer

What is safety aid reduction treatment for ptsd?

Many people were using TA to manage their own traumatic memories, and while they were not using TA to treat PTSD, a number of patients told therapists that TA helped them manage their traumatic memories. In a number of cases, TA would not address the traumatic memory directly but, rather, would simply ease the transition to accepting the traumatic memory. With TA, therapists may be not only treating patients suffering from PTSD but also treating patients who could be classified as emotionally vulnerable or emotionally vulnerable due to trauma.

Anonymous Patient Answer

What is the average age someone gets moral injury?

When using normative data from two independent populations (general population and psychiatric inpatient samples) to construct a normative sample of age of onset, it is not reasonable to expect that the average age of onset falls at an average of 50 years. It is much more likely that there will be differences in average age by the nature of the community from which the participants originate. Because there are no normative samples defined by country of birth (as in US data), this could change if more samples are available from other countries.

Anonymous Patient Answer
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