CLINICAL TRIAL

Exposure, Relaxation, and Rescripting Therapy for Moral Injury

Recruiting · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether a specific type of therapy may help reduce nightmares in veterans.

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About the trial for Moral Injury

Eligible Conditions
Arrhythmia, Sinus · Stress Disorders, Post-Traumatic · Respiratory Sinus Arrhythmia · Veterans · Nightmares · Actigraphy

Treatment Groups

This trial involves 2 different treatments. Exposure, Relaxation, And Rescripting Therapy 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.
Exposure, Relaxation, and Rescripting Therapy
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sleep and Nightmare Management
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Have stable housing for the duration of the study period
Have experienced any traumatic event meeting Criterion A for PTSD at least three months before the baseline assessment
Self-report experiencing trauma-related nightmares at least once per week for the past month, that are mostly-remembered and that cause awakening
Self-report global sleep disturbance indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI)
Be stable on any psychoactive medications for a minimum of two weeks before the baseline assessment
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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, 1-week post-treatment, 3-month follow-up
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 1-week post-treatment, 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 Exposure, Relaxation, and Rescripting Therapy will improve 3 primary outcomes, 2 secondary outcomes, and 6 other outcomes in patients with Moral Injury. Measurement will happen over the course of Nightly (Baseline until 1-week post treatment assessment; 7 weeks).

Change in Actigraphy-derived respiratory sinus arrhythmia (RSA)
NIGHTLY (BASELINE UNTIL 1-WEEK POST TREATMENT ASSESSMENT; 7 WEEKS)
Mattress actigraphy will be continuously recorded during the study period. RSA is the high frequency powers of heart period variability (0.15-0.4 Hz). Lower RSA indicates more cardiac vagal withdrawal.
Change in Actigraphy-derived sleep efficiency (SE)
NIGHTLY UP TO 7 WEEKS (BASELINE THROUGH 1-WEEK POST TREATMENT ASSESSMENT)
Mattress actigraphy will be continuously recorded during the study period. Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period. Lower sleep efficiency indicates worse sleep.
Home-based overnight polysomnography
BASELINE
Nox A1 portable polysomnography system (Nox Medical, Reykjavik, Iceland) used to record sleep stage measures and patterns of arousals, to calibrate sleep efficiency derived from the mattress system, and to detect sleep apnea.
Change in Nightmare Frequency
BASELINE PAST WEEK; NIGHTLY DURING BASELINE; 1-WEEK POST-TREATMENT; 3-MONTH FOLLOW-UP TREATMENT PERIOD
This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Nightly reports will be collected from daily sleep diaries and pushes to event markers during the night.
Change in Nightmare Severity
BASELINE; NIGHTLY DURING BASELINE; 1-WEEK POST-TREATMENT; 3-MONTH FOLLOW-UP TREATMENT PERIOD
The variable from the Trauma-Related Nightmare Survey assesses the severity of the nightmares experienced in the past week (range = 0 - 4) at each assessment (baseline, one week following treatment, and three months following treatment). Nightly reports of nightmare severity will be collected from daily sleep diaries. Higher scores indicate greater nightmare-related severity.
Change in Global Sleep Quality
BASELINE, 1-WEEK POST-TREATMENT, 3-MONTH FOLLOW-UP
Change in sleep Quality will be assessed using the Pittsburgh Sleep Quality Index, a 19-item self-report measure assessing qualities and problems associated with sleep in the past month. A global sleep quality score is obtained by summing seven component scores. Higher scores reflect poorer sleep quality. The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers. The addendum is used in conjunction with the PSQI for use with trauma-exposed participants and assesses the presence of seven trauma-related sleep disturbances.
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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.

Does moral injury run in families?

The present study demonstrates a clustering of both MD, MA, and PD in relatives. Because it is a common experience for patients to be confronted with the shocking news of their spouse's death and to be reminded of their own death many years later, it is important to discuss with dying patients the personal burden and stresses they perceive their impending death imposes upon them.

Anonymous Patient Answer

What is exposure, relaxation, and rescripting therapy?

Exposure, relaxation and rescripting therapy is a safe, practical method of helping family members and friends become better able to cope with a loved one's traumatic experience, and of helping that loved one work through troubling thoughts and emotions.

Anonymous Patient Answer

What is the latest research for moral injury?

Moral injury is a significant concept and needs to be further defined and researched to provide the best support for its identification and its treatment.

Anonymous Patient Answer

What are common treatments for moral injury?

A survey of patients with moral injury provides the opportunity to discuss current treatments and ascertain patients' perceptions of the benefits of therapies. To help clinicians to understand patients' perceptions and current perceptions regarding potential treatment options, future studies should evaluate treatment as a means to manage moral injury. There is also an opportunity to create a treatment-specific questionnaire to evaluate the possible value of moral injury in the context of treatment.

Anonymous Patient Answer

What is moral injury?

Moral injury is a common and significant concept in the healthcare field. In this article it is reported on the impact that the concept has had on nursing practice as well as on patient and nurse-career development. moral injury was defined by a nurse's decision that she or he no longer wanted to provide caring or palliative care for another on their unit. Moral injury is a major phenomenon with many effects on patient and nurse outcomes as well as the quality of nursing work. It is also a common phenomenon and has many negative consequences for society as a whole.

Anonymous Patient Answer

What causes moral injury?

The use of alcohol and drugs is also associated with moral injury in an individual, but is not the sole or dominant cause. Moral injury is also associated with other factors. Some people do not have these other factors, so it remains a mystery why some people continue a harmful lifestyle. Moral injury may lead to social isolation or social alienation. At the level of the social organization, moral injury has the potential to create a pervasive and sustained disruption to the social-legal-political-economic systems that supports our communities.

Anonymous Patient Answer

What are the signs of moral injury?

Moral injury affects women and girls in particular: they are highly associated with victim of violence and harassment. They also report the most intense signs of moral injury in comparison with those suffering from other types of physical and psychological trauma. In order to offer adequate care to these patients, we must be sensitive and attentive to this specific clinical situation that is very difficult to detect.

Anonymous Patient Answer

Can moral injury be cured?

The process of learning to define, resist and resist the influences of moral injury is the only process by which to achieve a state of being, and the only course of action to protect the person and family who has acted out of moral injury, or the only way through which to live with this damage internally and externally.

Anonymous Patient Answer

Have there been other clinical trials involving exposure, relaxation, and rescripting therapy?

There have been a limited number of studies using exposure, relaxation, and rescripting therapy. However, results of the studies indicate the feasibility of the therapy. Some studies suggest that there may be a placebo effect.

Anonymous Patient Answer

Is exposure, relaxation, and rescripting therapy safe for people?

Exposure- relaxation-rescripting therapy is safe and effective in the treatment of posttraumatic stress disorder and is equivalent to the treatment received by untreated controls. There is a need for rigorous clinical trials to establish the role of these interventions in managing traumatic events.

Anonymous Patient Answer

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

Maintaining a sense of self in the process of healing from a moral injury can be challenging and may ultimately add to the difficulty in adjusting to life after suffering such a devastating experience. For some, those suffering such a harm may only feel that they can cope if the recovery is facilitated by medical professionals.

Anonymous Patient Answer

Is exposure, relaxation, and rescripting therapy typically used in combination with any other treatments?

Exposure Therapy was significantly associated with an improvement of depressive, anxious, and somatic symptoms during the course of treatment, although in general only weak relationships between exposure measures were found. Relaxation therapy was additionally used in combination with exposure, relaxation with therapy, relaxation alone, and no treatment. In the case of anxiety and somatic symptoms only relaxation with therapy had a significant positive effect. Relaxation in combination with therapy, relaxation alone and no therapy were not beneficial. In the case of depression, only relaxation with therapy and relaxation alone were effective. Relaxation in combination with exposure was not effective. In the case of negative symptoms only relaxation with therapy and relaxation alone were effective.

Anonymous Patient Answer
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