Cognitive Processing Therapy for Moral Injury

Phase-Based Estimates
1
Effectiveness
1
Safety
Fort Belvoir Community Hospital, Fort Belvoir, VA
+2 More
Cognitive Processing Therapy - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Moral Injury

Study Summary

This study is evaluating whether a new treatment for PTSD is as effective as the current treatment.

See full description

Eligible Conditions

  • Moral Injury
  • Stress Disorders, Traumatic
  • Stress Disorders, Post-Traumatic
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cognitive Processing Therapy will improve 2 primary outcomes and 8 secondary outcomes in patients with Moral Injury. Measurement will happen over the course of Baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) and weekly or daily during treatment.

Month 4
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
Change in sleep disturbance as measured by the Insomnia Severity Index (ISI)
Change in somatic symptoms as measured by the Patient Health Questionnaire - 15 (PHQ-15)
Changes in alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Changes in anger as measured by the Dimensions of Anger Reactions-5 (DAR-5)
Changes in functioning as measured by the Well-Being Inventory (WBI)
Changes in health functioning as measured by the Veterans Rand 12-Item Health Survey (VR-12)
Month 4
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Change in suicidality as measured by the Depressive Symptom Index - Suicidality Subscale (DSI-SS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Standard Cognitive Processing Therapy
Massed Cognitive Processing Therapy (MCPT)

This trial requires 140 total participants across 2 different treatment groups

This trial involves 2 different treatments. 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.

Massed Cognitive Processing Therapy (MCPT)
Behavioral
Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions.
Standard Cognitive Processing Therapy
Behavioral
Cognitive Processing Therapy is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Standard CPT will be delivered in 12 one-hour sessions over 6 weeks and involves only individual sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Processing Therapy
2016
N/A
~2080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, one-month posttreatment, 4 months posttreatment (weeks 0, 5, 10, 17, 22, depending on tx condition) for reporting.

Who is running the study

Principal Investigator
J. S. W. P.
Jennifer Schuster Wachen Ph.D., Principal Investigator
VA Boston Healthcare System

Closest Location

Fort Belvoir Community Hospital - Fort Belvoir, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals who are 18 years of age or older and who are currently active duty military personnel and who are seeking treatment for PTSD are welcome at our center. show original
The PTSD diagnosis is determined by a clinician using the Posttraumatic Stress Scale (CAPS-5). show original
To be able to speak and read English fluently, you must practice a lot show original

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 stress disorders, traumatic a year in the United States?

Add answer

About 1.8 million and 5.4 million people suffer from stress disorders and traumatic life events respectively in the US a year. In the same period, around 7,000 people die from these conditions. Results from a recent clinical trial are significant in everyday life, since they highlight social stigma of mental illnesses.

Unverified Answer

What is stress disorders, traumatic?

Add answer

Stress disorders are often traumatic experiences in the context of a dysfunctional attachment relationship with one or more parents (see attachment disorder) and/or stressful events in childhood. (See attachment theory).

Unverified Answer

Can stress disorders, traumatic be cured?

Add answer

Stress counseling can reduce stress-related symptoms. There is a risk of overdiagnosis in some groups, but stress counseling can help to make appropriate decisions about intervention.

Unverified Answer

What are the signs of stress disorders, traumatic?

Add answer

Signs of stress disorders have been discussed previously. However, there is a large body of literature that suggests the development of stress disorders may be accompanied by physical symptoms such as somatic complaints, depression, anxiety and insomnia. For example, a review of research suggests the link between somatosensory (pain) sensitivity, depression and sleep disturbances. The link between stress-related changes in sleep patterns have also been explored (for review, see, ). The same review also suggested that women with stress-related sleep disturbances were shown to have more somatic symptom complaints than men.

Unverified Answer

What causes stress disorders, traumatic?

Add answer

Stress arises when the body does not receive the right amount or combination of stressors. This imbalance can be caused by a number of factors, including a stressful stimulus, a failure of the organism to effectively cope with stress, a change in environmental factors such as temperature, and psychological factors such as psychological pain which in turn will cause a release of hormones from the hypothalamus which in turn will cause an increase in the release of corticotropin-releasing hormone. The presence of stress disorders can lead to stress-related psychological distress such as burnout as well as emotional and physical disorders.

Unverified Answer

What are common treatments for stress disorders, traumatic?

Add answer

Cognitive behavioral therapy (CBT) is used to treat stress disorder patients. Patients with PTSD are often prescribed multiple medications over the course of their treatment. Treatment plans are often created by team members in the treatment plan. CBT can be quite useful in treating stress related disorders. CBT is also an extremely efficient approach in controlling stress induced by traumatic events, including PTSD.

Unverified Answer

Does cognitive processing therapy improve quality of life for those with stress disorders, traumatic?

Add answer

Results from a recent clinical trial suggest that a single-session of CBT, for 8 weeks, may be effective in improving QoL among individuals with stress and traumatic brain injury.

Unverified Answer

Have there been other clinical trials involving cognitive processing therapy?

Add answer

There were few major limitations in this trial; however, the sample size was relatively small and the primary test was only of moderate sensitivity. Results from a recent paper of this preliminary study will be valuable in supporting the design of future trials. Although the results from this study do not seem to indicate that CPT may be an effective treatment, as yet, there is a need for further research using adequate power to assess its effectiveness.

Unverified Answer

How serious can stress disorders, traumatic be?

Add answer

Data from a recent study of the present study can be explained by two factors: (1) most patients with stress disorders suffer from multiple, comorbid mental and physical health problems, and (2) patients can perceive stress to be a major problem and seek treatment, although clinicians should be more alert to the potential psychological consequences and the need for more aggressive and interdisciplinary treatment.

Unverified Answer

Is cognitive processing therapy safe for people?

Add answer

A CBT intervention in which people work with their own processing information in therapy was not associated with increased risk of PTSD. This approach may be safely embraced by those experiencing high trauma stress and their carers. This therapy may reduce the risk of the development of PTSD and is a novel intervention to help treat the symptoms of stress-related anxiety and depression.

Unverified Answer

Who should consider clinical trials for stress disorders, traumatic?

Add answer

The following 3 predictors of a high-risk score for PTSD should be considered in order to increase the chances of receiving a diagnostic evaluation for PTSD following a traumatic event: female gender, a history of substance abuse, and witnessing interpersonal violence.

Unverified Answer

Have there been any new discoveries for treating stress disorders, traumatic?

Add answer

Stress-related medical conditions are becoming more prevalent in the health care system in recent years. It has been found that one of the most alarming conditions faced by trauma patients is their increased incidence of the psychological disease of stress. Even as these medical conditions have been well recognized in the modern environment of trauma care it is clear that their optimal therapeutic treatment and management have yet to be found. This is most likely due to a lack of basic scientific knowledge. This information is presented herein for medical readers alike in order to better assess and treat medical conditions related to stress from the perspective of psychological medicine.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Moral Injury by sharing your contact details with the study coordinator.