CLINICAL TRIAL

Procedure: Acupuncture for Moral Injury

Recruiting · 18 - 65 · All Sexes · Long Beach, CA

This study is evaluating whether acupuncture may help reduce symptoms of post-traumatic stress disorder.

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About the trial for Moral Injury

Eligible Conditions
Stress Disorders, Post-Traumatic · Post Traumatic Stress Disorder (PTSD)

Treatment Groups

This trial involves 2 different treatments. Procedure: Acupuncture is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. 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.
Procedure: Acupuncture
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Procedure: Sham acupuncture
PROCEDURE

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Veterans age 18 to 55
DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
At least moderate PTSD by having a total CAPS-5 score of > 26 and meeting criteria for each of 4 symptom clusters.
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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, 6 weeks, 12 weeks, and 13 weeks (1-month after end of treatment)
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 6 weeks, 12 weeks, and 13 weeks (1-month after end of treatment)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 6 weeks, 12 weeks, and 13 weeks (1-month after end of treatment).
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 Procedure: Acupuncture will improve 1 primary outcome and 1 secondary outcome in patients with Moral Injury. Measurement will happen over the course of Baseline, 12 weeks.

Change in EMG eyeblink startle from before to after treatment
BASELINE, 12 WEEKS
The startle response, measured with electromyography (EMG) of the eyeblink, provides an ideal translational tool to investigate fear conditioning and extinction, since the amygdala is directly connected with the startle circuit. The raw EMG signal will be recorded at a rate of 1000 Hz throughout the experimental session using a 28 Hz high pass and 500 Hz low pass filter (as recommended by guidelines for human eyeblink startle in Blumenthal et al., 2005; Psychophysiology, 42:1-15). Raw signals will be stored and exported for analysis in microvolt ( V) values.
BASELINE, 12 WEEKS
Change in PTSD symptom severity on the Clinician Administered PSTD Scale - CAPS 5 from before to after treatment
BASELINE, 6 WEEKS, 12 WEEKS, AND 13 WEEKS (1-MONTH AFTER END OF TREATMENT)
The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of >2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. A DSM-5 CAPS cutoff score of >26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
BASELINE, 6 WEEKS, 12 WEEKS, AND 13 WEEKS (1-MONTH AFTER END OF TREATMENT)

Patient Q & A Section

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

What is moral injury?

Moral injury is an experience that affects ethical, moral and psychological well-being and is characterized by 'injury' due to 'harm'. The experience of moral injury is associated with distress but with greater benefit, in line with a self-esteem approach to moral functioning. Results from a recent clinical trial call for future work to define the experience of moral injury, its nature and effects, and to examine approaches to treatment and recovery.

Anonymous Patient Answer

Can moral injury be cured?

The findings of this study emphasize the need to consider moral injury as a distinct psychopathological category. As such, it requires the development and refinement of specific interventions and psychoanalytic therapies for moral injury as a dissociated, separate clinical entity of its own.

Anonymous Patient Answer

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

Almost 1 in 10 U.S. adults experienced some form of moral injury in the prior year, with significant gender- and age-related differences, suggesting the need for national priorities in these areas.

Anonymous Patient Answer

What are the signs of moral injury?

Moral injury is characterized by the inability to empathize with others, feeling like one is on the periphery, a sense of betrayal, and an inability to control one's thoughts. For these reasons the clinician should suspect moral injury when patients complain of feelings of isolation or alienation, or when the patient fails to give themselves a high moral value. Moral injury can manifest as avoidance and alienation. These signs may be exacerbated by a loss of social support network. moral injury could be a diagnosis to watch in the future if properly evaluated.

Anonymous Patient Answer

What causes moral injury?

Moral injury can and does impact on people's lives, but a single cause does not necessarily explain how it manifests. It is likely to be a combination of many factors and is not limited to a breakdown in family or social supports.

Anonymous Patient Answer

What are common treatments for moral injury?

It is difficult to give a single, comprehensive treatment for moral injury, a result of the multifaceted nature of moral injury, its complexity as a psychiatric disorder which might not be adequately treated with an a single, definitive treatment. Some treatments seem to be more desirable for some aspects of moral injury than others. Psychotherapy is recommended in most cases to help patients to deal with trauma and other problems that may be responsible for their moral injury.

Anonymous Patient Answer

Have there been any new discoveries for treating moral injury?

Moral injury is [not often recognized, but it may be a problem if it appears or becomes apparent. A 2017 survey found only 29% of practicing clinicians had ever heard of the condition or had ever treated it. Moral injury is a common moral problem that affects people from diverse backgrounds. The condition was not well described in the literature. A 2017 review found only 15 clinical studies on treatments for moral injury. The treatments for moral injury were mostly based on principles from other fields, and therefore had limited acceptance or relevance to patients and clinicians. This review noted that moral injury can occur in many situations and is not [just a condition that is typically encountered only in emergencies.

Anonymous Patient Answer

Does procedure: acupuncture improve quality of life for those with moral injury?

The improvement in QOL seen in acupuncture may be due partly to the effect on psychological, physical, and social well-being. Data from a recent study warrant further study and future trials designed primarily for this group.

Anonymous Patient Answer

Who should consider clinical trials for moral injury?

The majority (97.2%) of our respondents have heard about medical ethics and clinical trial protocols but only 5.9% have ever read one. The participants had not heard about medical trials involving the possibility of receiving money. When asked if they would consider participating in any clinical trial that may help others, 89.3% responded that they would consider. In the event of a hypothetical medical condition like moral injury, there ought to be no moral objections that would prevent patients from volunteering for any research even if the conditions for research were not ethical such.

Anonymous Patient Answer

Have there been other clinical trials involving procedure: acupuncture?

In general, most studies using acupuncture for treatment of patients with chronic pain in China and Europe demonstrate feasibility of acupuncture using a variety of techniques in different types of patients. In few of these trials the acupuncture and/or sham acupuncture were performed by the same or almost the same people in a setting with a high likelihood of contamination. The trials using acupuncture in the context of treatment of noninfectious diseases such as chronic fatigue syndrome in China and Europe also show that acupuncture with a high likelihood of contamination is not necessarily the same as acupuncture without such contamination (or sham + credible non-sham + credible non-sham).

Anonymous Patient Answer

Is procedure: acupuncture safe for people?

Patient and physician satisfaction can be enhanced by using clear expectations and appropriate patient information, and the use of clear procedures of acupuncture for pain relieving effect and preventive effect is safe in terms of serious adverse events and procedural adverse events.

Anonymous Patient Answer

Does moral injury run in families?

The study results are consistent with the model of Moll and colleagues that identifies four distinct types of moral injuries, which are associated with specific psychosocial profiles and can be understood within the perspectives of the Big Five models with an emphasis on the role of family relationships.

Anonymous Patient Answer
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