CLINICAL TRIAL

CPT-Text for Moral Injury

Recruiting · 18+ · All Sexes · Palo Alto, CA

This study is evaluating whether a texting-based intervention can increase engagement in a PTSD treatment.

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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 6 different treatments. CPT-Text is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
CPT-Text
BEHAVIORAL
+
Retention Incentive
BEHAVIORAL
Experimental Group 2
CPT-Text
BEHAVIORAL
+
Reminder as Usual
BEHAVIORAL
Control Group 3
Reminder as Usual
BEHAVIORAL
+
Texting as Usual
BEHAVIORAL
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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:
Over the age of 18 residing in the United States; Criterion A event measured by the Life Events Checklist for DSM-5 (LEC-5); and significant symptoms of PTSD as evidenced by a score of 33 or above on the PCL-5; PTSD symptoms that began or increased during the COVID pandemic (per self-report); registered/registering on Talkspace for messaging-based therapy and ownership of a personal device for texting. In a state with therapist capacity on the Talkspace platform
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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 through 24 weeks at 3 timepoints
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline through 24 weeks at 3 timepoints.
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 CPT-Text will improve 1 primary outcome and 7 secondary outcomes in patients with Moral Injury. Measurement will happen over the course of Baseline through week 8.

Behavioral Intention
BASELINE THROUGH WEEK 8
Behavioral Intention (BI; which captures motivation to engage in a behavior) will be measured to examine patterns of motivation in our treatment conditions and to investigate BI as the hypothesized mechanism of change in engagement. BI measures are created based on recommendations for constructing a very brief BI measure, a frequent approach to measuring this construct, which has demonstrated reliability [119-123] . Participants will be asked, "How likely or unlikely are you to complete (baseline) or continue (mid-treatment) treatment?" on a 7-item Likert scale ranging from "Extremely Unlikely" to "Extremely Likely" at the baseline and both mid-treatment assessments.
Patient Health Questionnaire (PHQ-9)
BASELINE THROUGH 24 WEEKS
The PHQ-9 [115,116] is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders that will be administered on the schedule outlined in the table. The PHQ-9 is the 9-item depression module and is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
The Client Satisfaction Questionnaire (CSQ)
BASELINE THROUGH 24 WEEKS
The Client Satisfaction Questionnaire (CSQ; [118] ) is an 8-item measure of participant satisfaction with treatment.
PTSD Checklist for DSM-5 (PCL-5)
BASELINE THROUGH 24 WEEKS
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that evaluates the degree to which individuals have been bothered by PTSD symptoms tied to their most currently distressing event [114] . The monthly version will be administered at baseline and the weekly version thereafter.
The Brief Inventory of Psychosocial Functioning (B-IPF)
BASELINE THROUGH 24 WEEKS
The Brief Inventory of Psychosocial Functioning (B-IPF; [117] ) is a 7-item self-report instrument measuring respondents' level of functioning over the past 30 days in seven life domains including: romantic, family, parenting, friendship, work, education, and self-care.
Working Alliance Inventory, Short Form (WAI-SF)
WEEK 1 THROUGH WEEK 12
The Working Alliance Inventory, Short Form (WAI-SF, [125] ) is a measure to index the degree of therapeutic cohesion between the client and the therapist.
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Who is running the study

Principal Investigator
S. W. S.
Prof. Shannon Wiltsey Stirman, PhD
Stanford University

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?

About 2.0 million people in the United States are estimated to experience moral injury in 2008. However, in this study, it is difficult to determine how many of those are hospitalized since most persons with moral injury are discharged after one hospital stay, with one or two visits to physicians who are most likely not aware of them and of their underlying problems.

Anonymous Patient Answer

What are common treatments for moral injury?

The most common treatment for moral injury is psychotherapy, especially cognitive behavioral therapy; in one study in Sweden, it was found that 81 percent of respondents had tried psychotherapy. In addition, about half of the study group also reported having been given medication. It is crucial to take the patient's case history to find out about the patient's past experiences as well as their present or future symptoms so as to decide on the most effective treatment.

Anonymous Patient Answer

Can moral injury be cured?

Moral injury is very hard to cure as a group, particularly if the groups that experience the problem are also the ones who have traditionally been considered to possess a propensity towards morally injurious behavior. At a family unit level, however, a degree of success is possible. This may be one potential option for treating moral child discipline problems.

Anonymous Patient Answer

What are the signs of moral injury?

Moral injury is likely to occur when one person abuses the rights of another by forcing them into an unacceptable position or by inciting them to behave deceptively. It can manifest itself in the form of a range of psychological and emotional symptoms including depression, shame, guilt, self-hatred and a loss of agency and identity. The symptoms of moral injury present themselves in a variety of ways and manifest themselves for as long as they will. Some moral injury-affected people are aware of their situation but do not dare confront it, preferring to go through with life in a way whereby they can claim to be a "normal" person rather than a moral loser. This is a personal choice rather than an inevitable development.

Anonymous Patient Answer

What causes moral injury?

The present study demonstrates the complexity of causal identification because of many confounding variables impacting on the development of moral injury. The analysis in the first instance identified two causal variables that account for a considerable portion of the variation in moral injury: a lack of awareness of a risk factor and perceived likelihood of exposure to a risk factor. The lack of awareness variable provides insight into how the attitude of those exposed to the risk factor may affect the attitude of those not exposed to the risk factor. Perceived likelihood of exposure to a risk factor provides a significant factor for the development of the second type of moral injury; i.e., that individuals may not want to admit that they are considering the likelihood of exposure to a potential risk factor.

Anonymous Patient Answer

What is moral injury?

Moral injury (MI) occurs in a variety of settings and people of any age. It is characterized by feelings of guilt, shame, and/or disgust after an act of harm that comes as a result of a moral obligation to the self and/or others. MI is not limited to medical encounters or medical professionals, and in fact affects people from a variety of social and moral backgrounds.

Anonymous Patient Answer

Have there been other clinical trials involving cpt-text?

This article presents the first use of a clinical trial. The development of the clinic was a result of our interest in the field of [liver cancer](https://www.withpower.com/clinical-trials/liver-cancer) and chronic liver injury; we wanted to see whether we could use our experiences and the knowledge already available to develop a clinical trial. It was not until the publication of the cpt-text that the clinical trial became a reality. We present a case report with pictures illustrating the history of the development of the clinic. Because of the many challenges we faced in creating the clinic, our experience will help other cancer and liver-related clinics in their approaches to the issue of clinical research ethics.

Anonymous Patient Answer

What is the average age someone gets moral injury?

There is variability in which people are at highest risk. Given the complexity and seriousness of moral injury, it is essential to identify and target those particularly vulnerable.

Anonymous Patient Answer

How serious can moral injury be?

Morbimax, PVS, and MCI are associated with serious injuries and death from motor vehicle crashes. The PVS is associated with the highest risk of fatality and is a better predictor of injury severity than other models.

Anonymous Patient Answer

Has cpt-text proven to be more effective than a placebo?

CPT-text has demonstrated statistically significant decreases in psychological distress among veterans at all 9 assessment visits. The treatment effect size of the CPT-text intervention in reducing psychological distress was 0.49 (p<.001), comparable to that of other treatments known to alleviate psychological distress. The effect sizes of the CPT-text intervention were in the same order of magnitude as other therapies known to lower psychological distress. Overall CPT-text had clinically meaningful effects.

Anonymous Patient Answer

What is the primary cause of moral injury?

The authors concluded that moral injury is a complex problem that is multifactorial, but may also reflect a failure to appreciate the value of others.

Anonymous Patient Answer

What is cpt-text?

The clinical usefulness of cpt-text has been questioned by a number of commentators. The clinical trials, particularly for lung function improvement, do not give a clear evidence base. There is evidence that there is no effect, that there might be an effect that is small and that the evidence is likely to be underpowered. There is a case that where evidence has been produced to help develop treatments and evidence is in short supply, clinicians should use the technology to its full extent.

Anonymous Patient Answer
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