CLINICAL TRIAL

Case Formulation plus Cognitive Processing Therapy for Moral Injury

Recruiting · 18+ · All Sexes · Houston, TX

A Case Formulation Approach to Cognitive Processing Therapy

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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. Case Formulation Plus Cognitive Processing 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.
Case Formulation plus Cognitive Processing Therapy
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Cognitive Processing Therapy
BEHAVIORAL

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Veterans with posttraumatic stress disorder (PTSD)
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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: Session progress notes will be written by clinician following each weekly treatment session through study completion (an average of three months). This will reflect participant change and progress over the course of the week as well as current status.
Screening: ~3 weeks
Treatment: Varies
Reporting: Session progress notes will be written by clinician following each weekly treatment session through study completion (an average of three months). This will reflect participant change and progress over the course of the week as well as current status.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Session progress notes will be written by clinician following each weekly treatment session through study completion (an average of three months). This will reflect participant change and progress over the course of the week as well as current status..
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether Case Formulation plus Cognitive Processing Therapy will improve 2 primary outcomes and 22 secondary outcomes in patients with Moral Injury. Measurement will happen over the course of Administered at baseline, daily throughout therapy, and two weeks following treatment (post-treatment)..

Daily monitoring diary (assessing change over time)
ADMINISTERED AT BASELINE, DAILY THROUGHOUT THERAPY, AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
This idiosyncratic measures assesses the frequency and severity of any challenges to optimal therapy outcomes described by the participant in the case formulation session. The diaries are locally constructed and assess challenges to optimal therapy outcomes. The frequency and intensity of each challenge is assessed daily on a 0-5 likert scale. Change over time can be calculated using a formula to derive a composite symptom reduction score. This score can be interpreted as a percent improvement over a specified timeframe.
ADMINISTERED AT BASELINE, DAILY THROUGHOUT THERAPY, AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
Brief Addiction Monitor (assessing change over time)
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
This measure assesses alcohol and drug use and craving. The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients in treatment for a substance use disorder (SUD). The BAM includes items that assess risk factors for substance use, protective factors that support sobriety, and drug and alcohol use (items 4-7G). The BAM produces composite scores for the three aforementioned domains. The instrument can be used in treatment planning, progress monitoring, and group or individual psychotherapies for SUD.
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
Veterans Rand Short Form (assessing change over time)
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
This measure assesses health conditions and concerns about health conditions. The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status.
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
Trauma Interview
ADMINISTERED AT BASELINE
This locally constructed interview assesses the participant's trauma history over the course of the lifetime.
ADMINISTERED AT BASELINE
Weekly stress inventory (assessing change over time)
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
This inventory measures minor life events and hassles. The WSI is an 87-item self-report scale used to assess the occurrence of minor stressors over a week's time. Individuals rank items on an 8-point Likert scale, with values ranging from 0 (did not occur) to 7 (extremely stressful). Two scores are obtained, the event score (WSI-E) which is the total number of events endorsed and the impact score (WSI-I), which is the summation of the subjective ratings of distress for the items endorsed.
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
Insomnia Severity Index (ISI) (assessing change over time)
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
This measure assesses the presence and severity of insomnia. Subjective sleep disturbance over the past week was also assessed with the Insomnia Severity Index. A seven item measure that assesses perceived insomnia severity and daytime distress caused by insomnia. The scale yields a total score indicating level of insomnia with clinical cutoffs as follows: 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia, 22-28 = severe clinical insomnia. The ISI has shown good internal consistency (alpha = 0.74) in a clinical sample and high reliability in the current sample (alpha = 0.83).
ADMINISTERED AT BASELINE, MID-TREATMENT (AFTER SESSION 6), AND TWO WEEKS FOLLOWING TREATMENT (POST-TREATMENT).
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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.

What are the signs of moral injury?

As many as three out of four respondents had one or more signs of moral injury. Men showed more signs than women. People in the middle ages group were more likely to show symptoms. Those who experienced more serious crime showed signs of more severe damage.

Anonymous Patient Answer

What causes moral injury?

We conclude that moral injury is an important cause of psychological trauma that occurs in the military setting. Moral distress and trauma represent new approaches to the problems of the combat injured. We discuss the relevance of our findings to the discussion of mental health and trauma care in the military setting.

Anonymous Patient Answer

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

There are an estimated 1% of the population each year that report having been harmed by someone's moral failure or failing of that of another; they suffer 1.5 million cases of moral hurt in a year in the United States.

Anonymous Patient Answer

Can moral injury be cured?

Recent findings of this study are promising and may provide clinical support for the concept of moral injury. Further research should explore the theoretical links between moral injury and moral reasoning and the implications for coping among youth in a variety of settings before this link is fully explored.

Anonymous Patient Answer

What is moral injury?

The concept of moral injury is useful across many disciplines with the aim of understanding and preventing harm across the medical, psychological and social fields. Our work has contributed to a greater understanding of the concept of mental illness. The conceptualization and implementation of our framework of moral injury (MI) may enable clinicians to use the best available evidence more efficiently when assisting individuals of all backgrounds and at all points across the lifespan. Future work to improve our understanding of the concept of MI is needed, in order to optimize the conceptual and practical application of MI as a tool.

Anonymous Patient Answer

What are common treatments for moral injury?

The treatment of moral injury needs to move beyond a focus on immediate physical problems. Instead hospitals and other health care settings should focus on helping survivors understand their moral injuries' sources and on how they have impacted them. Findings from a recent study provides a practical and comprehensive overview of available treatment resources.

Anonymous Patient Answer

Have there been any new discoveries for treating moral injury?

To encourage a greater understanding of this specific field of research, in this work this article highlights the clinical implications of these new findings and the importance of future research.

Anonymous Patient Answer

What is the latest research for moral injury?

Moral injury in healthcare settings is a relatively new phenomenon. Thus, we lacked relevant and updated evidence for moral injury. As there is still a need to increase the knowledge and provide information for moral injury, we must [carry out research on moral injury in healthcare settings]. The data on ethical considerations and other types of knowledge about moral injury are also required to provide further insight into moral injuries in healthcare settings.

Anonymous Patient Answer

How serious can moral injury be?

The definitions of serious injury differ around the world, and in some cases different injuries have similar seriousness profiles. This article is not intended to give specific numerical estimates of the frequency or severity of moral injury. The following definitions and criteria are used to guide the scope of this overview, and should not be applied beyond this scope. Moral injury appears to be an emerging injury. It is not included in official data collection schemes. The injury is not explicitly included in medical injury databases. In the UK, the NHS Inpatient Hospital Discharge Data for 1999–2000 gives the frequency of discharge with a diagnosis of "moral injury.

Anonymous Patient Answer

Have there been other clinical trials involving case formulation plus cognitive processing therapy?

The cognitive processing therapy as part of case formulation has been conducted in a few clinical trials. While these trials demonstrate the positive impact of treatment with case formulation plus cognitive processing therapy on the treatment outcomes of the patients, no randomized clinical trial has been conducted to test the usefulness of this treatment in patients with posttraumatic stress disorder. This finding is relevant to the current interest in this area. In addition, case formulation plus cognitive processing therapy has been used in several clinical trials. However, it is evident that more research is required to verify its efficacy and to demonstrate its long-term effects.

Anonymous Patient Answer

What is the primary cause of moral injury?

Moral injury seems to be a direct cause of moral distress, and moral distress is associated with psychological distress, such as guilt, shame, and sadness. The present study confirms the association between moral injury and depression and other forms of psychological distress, such as hopelessness, anger and guilt after controlling for other factors. However, we did not find any direct association between moral injury and psychological distress. We argue that the primary cause of moral injury is the sense of being the victim of injustice. This sense of injustice is also associated with depression and other forms of psychological distress. For this reason, our results raise the possibility that moral injury directly relates to psychological distress more strongly than other factors.

Anonymous Patient Answer

What are the common side effects of case formulation plus cognitive processing therapy?

The common side effects of CpT were nausea (33% of patients), headache (31%), and dizziness (31%). The most common symptom experienced by patients was fatigue (31% of patients). CpT was generally well tolerated when using only cognitive processing therapy.

Anonymous Patient Answer
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