What is the mechanism of action of this treatment?

Common treatments for Moral Injury, particularly in veterans, often involve culturally responsive and user-centered design approaches. These treatments focus on addressing the unique experiences and needs of patients by integrating multiple therapeutic techniques, such as cognitive-behavioral therapy (CBT), group therapy, and trauma-focused interventions. The mechanisms of action include altering maladaptive thought patterns, fostering emotional expression, and promoting social support within a culturally sensitive framework. This approach is crucial for Moral Injury patients as it ensures that the treatment is relevant and respectful of their experiences, thereby enhancing engagement and effectiveness.

What side effects are associated with this type of intervention?

Common treatments for Moral Injury, particularly those involving group therapy and culturally responsive, user-centered designs, often include cognitive-behavioral therapy (CBT) and exposure therapy. Known side effects of these treatments can include temporary increases in distress or anxiety as individuals confront traumatic memories. Some patients may experience emotional discomfort or fatigue due to the intensity of the sessions. However, these side effects are generally manageable with proper therapeutic support and are outweighed by the long-term benefits of reduced PTSD symptoms and improved emotional functioning.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Moral Injury. However, treatments for PTSD, which is closely related, include medications such as sertraline and paroxetine, and therapies like cognitive-behavioral therapy (CBT) and prolonged exposure therapy. The trial Group Therapy Manual emphasizes culturally responsive and user-centered design, which aligns with the need for personalized and culturally sensitive approaches in PTSD treatment. These approaches are crucial for addressing the unique experiences and needs of individuals suffering from Moral Injury.

What other types of research exist?

Promising alternatives to Group Therapy Manual for PTSD treatment in moral injury patients include: 1) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which has shown feasibility in diverse populations; 2) Culturally responsive therapies like Buddhist-Informed Therapy for Bhutan (BT-B), which integrates local cultural beliefs with evidence-based practices; and 3) Mentalization-Based Treatment (MBT), which focuses on improving patients' ability to understand their own and others' mental states. These approaches offer tailored, effective treatment options that consider the unique cultural and psychological needs of moral injury patients.

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Group Therapy for PTSD After Combat (CAC Trial)

Phase < 1

Recruiting

Led By Sheila Frankfurt, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help combat veterans with PTSD from morally injurious events by using group therapy. Veterans will talk about their experiences with others who understand, helping them make sense of their feelings and improve their mental health.

Who is the study for?

This trial is for English-speaking Veterans, aged 18 or older, enrolled in Central Texas Veterans Healthcare System who have combat experience and are struggling with reintegration due to moral injury. They must recognize their worst trauma as a morally injurious event, show significant functional impairment, and agree to the study's terms.

What is being tested?

The trial is testing a new group therapy manual designed specifically for combat veterans. It aims to address unique challenges faced by these individuals when reintegrating into civilian life after experiencing traumatic events during service.

What are the potential side effects?

Since this is a psychological intervention involving group therapy sessions rather than medication or medical procedures, side effects may include emotional discomfort or distress related to discussing traumatic experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre intervention (baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Acceptability of Intervention Measure (AIM)

Change in Feasibility of Intervention Measure (FIM)

Change in Implementation Appropriateness Measure (IAM)

+1 more

Secondary study objectives

Change in Beck Depression Inventory-II (BDI-II)

Change in Beck Scale for Suicide Ideation (BSS)

Change in Brief Expressions of Moral Injury Scale (EMIS)

+6 more

Other study objectives

Columbia Suicide Severity Rating Scale (C-SSRS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open Pilot TrialExperimental Treatment1 Intervention

Open pilot trial of a group therapy manual.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Moral Injury, particularly in veterans, often involve culturally responsive and user-centered design approaches. These treatments focus on addressing the unique experiences and needs of patients by integrating multiple therapeutic techniques, such as cognitive-behavioral therapy (CBT), group therapy, and trauma-focused interventions. The mechanisms of action include altering maladaptive thought patterns, fostering emotional expression, and promoting social support within a culturally sensitive framework. This approach is crucial for Moral Injury patients as it ensures that the treatment is relevant and respectful of their experiences, thereby enhancing engagement and effectiveness.

Assessment and treatment approaches for survivors of torture.Solution Focused Brief Therapy Telemental Health Suicide Intervention.Participants' perspectives of feasibility of a novel group treatment for people with cognitive communication difficulties following acquired brain injury.