CART for Anger Issues

(CART Trial)

Overseen By Alan Peterson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Suicidality, Homicidal, Brain injury, Alcohol, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 7-14 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART), can assist military service members and veterans in managing anger and aggression stemming from past betrayals. Participants will be divided into groups with varying wait times before beginning the 14-module treatment. Surveys will monitor their satisfaction and progress at different stages. The trial seeks active duty military members or veterans who have experienced intense anger and acted aggressively in the past month. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new therapeutic approaches for anger and aggression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CART treatment is safe for military service members and veterans?

Research has shown that CART treatment, which addresses chronic anger and aggression from past traumas, has been tested in earlier studies. These studies focused on military personnel dealing with anger related to feelings of betrayal. Initial findings suggested that CART is generally well-tolerated, as participants did not usually experience serious side effects. While these early results are promising, they do not guarantee the same experience for everyone. Overall, CART appears to be a safe option for managing anger and aggression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CART method for treating anger issues because it specifically targets the roots of chronic anger and aggression linked to past trauma and transgressions. Unlike traditional approaches that might rely heavily on medication or general therapy techniques, CART focuses on addressing the underlying trauma, potentially leading to more effective and lasting changes in behavior. Additionally, by experimenting with different wait times before starting treatment, researchers hope to optimize the timing for interventions, enhancing the effectiveness of the therapy. This personalized approach could pave the way for more tailored and impactful treatments for those struggling with anger management.

What evidence suggests that CART might be an effective treatment for anger issues?

Research has shown that the CART treatment helps people manage anger and aggression, particularly stemming from past betrayals. This approach considers how past traumatic experiences can influence current behavior. Early results suggest that CART is practical, and participants generally find it satisfying. While detailed results on its effectiveness are still being gathered, the focus on culturally relevant methods aims to specifically address ongoing anger and aggression. The treatment includes 14 sessions, providing a structured plan to address these issues step by step. Participants in this trial will be randomized into groups with different wait times before starting the CART treatment, allowing researchers to assess the impact of wait time on treatment outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Vanessa Jacoby, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Alan Peterson, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for active duty military members and veterans aged 18 or older who are dealing with chronic anger and aggression due to past betrayal. Participants must be able to attend treatment sessions in a military outpatient setting.

Inclusion Criteria

Endorses a history of military-related betrayal on the Modified Moral Injury Questionnaire

I am an adult military member or veteran aged 18 or older.

Endorses problematic anger in the past month (as evidenced by a score of 12 or above on the Dimensions of Anger Reactions; DAR-5)

Exclusion Criteria

Experiencing active psychosis or mania as measured by the Prodromal Questionnaire-Brief Version and the Mood Disorders Questionnaire

Participated in an anger management or trauma-focused intervention within the past 3 months as assessed by self-report

Acute suicidality requiring immediate intervention, such as hospitalization as assessed by the Depressive Symptoms Index-Suicidality Subscale (DSI-SS) combined with follow-up clinical interview for elevated scores

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Wait Time

Participants complete assessments and weekly check-ins during a randomized wait time period

2-4 weeks

2 assessments per week, 1 phone call per week

Treatment

Participants undergo 14 modules of CART treatment, with bi-weekly sessions

7-14 weeks

14 sessions (in-person or virtual)

Follow-up

Participants complete a follow-up assessment 4-8 weeks after treatment

4-8 weeks

1 follow-up assessment (online)

What Are the Treatments Tested in This Trial?

Interventions

• Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART)

Trial Overview The study tests the CART program, which includes 14 modules given twice a week aimed at managing anger and aggression from betrayal trauma. The effectiveness will be measured by participant satisfaction and reduction in symptoms, with different groups starting treatment after varying wait times.

How Is the Trial Designed?

Group I: 4-week wait time group Experimental Treatment 1 Intervention

This group is randomized to a 4-week wait time prior to treatment with CART

Group II: 3-week wait time group Experimental Treatment 1 Intervention

This group is randomized to a 3-week wait time prior to treatment with CART

Group III: 2-week wait time group Experimental Treatment 1 Intervention

This group is randomized to a 2-week wait time prior to treatment with CART

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a phase 3 clinical trial with 90 participants suffering from severe PTSD, MDMA-assisted therapy significantly reduced PTSD symptoms compared to placebo, with a large effect size (d = 0.91).

The treatment was found to be safe and well-tolerated, showing no adverse events related to abuse potential or suicidality, suggesting it could be a promising new option for PTSD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Mitchell, JM., Bogenschutz, M., Lilienstein, A., et al.[2023]

In an 8-week trial with 14 adult participants suffering from PTSD, citalopram significantly reduced core symptoms such as re-experiencing, hyperarousal, and avoidance, with 9 out of 11 completers classified as 'responders'.

Citalopram was well-tolerated with no dropouts due to adverse effects, suggesting it is a safe option for treating PTSD, although further confirmation through more rigorous trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open trial of citalopram in adults with post-traumatic stress disorder. Seedat, S., Stein, DJ., Emsley, RA.[2019]

In a study of 61 adolescent girls with PTSD, high levels of state anger at the beginning of treatment were linked to poorer outcomes in client-centered therapy (CCT) compared to prolonged exposure therapy for adolescents (PE-A).

The findings suggest that PE-A may be more effective for adolescents with high anger levels, as it showed less impact of anger on treatment outcomes compared to CCT, indicating the importance of therapy type in managing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Moderating Effect of State Anger on Treatment Outcome in Female Adolescents With PTSD. Kaczkurkin, AN., Asnaani, A., Zhong, J., et al.[2020]

MDMA-assisted psychotherapy has received Breakthrough Therapy Designation from the FDA for treating PTSD, showing a large effect size in studies compared to the small to moderate effects of traditional medications like paroxetine and sertraline.

This treatment approach, which involves MDMA administration during psychotherapy sessions, demonstrated better safety profiles and lower dropout rates than conventional antidepressants, with minimal risk of overdose or withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. Feduccia, AA., Jerome, L., Yazar-Klosinski, B., et al.[2020]

In a phase 3 clinical trial with 90 participants suffering from severe PTSD, MDMA-assisted therapy significantly reduced PTSD symptoms compared to placebo, with a large effect size (d = 0.91) and a mean CAPS-5 score change of -24.4 in the MDMA group.

The treatment was found to be safe and well-tolerated, showing no adverse events related to abuse potential, suicidality, or QT prolongation, even among participants with common comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Mitchell, JM., Bogenschutz, M., Lilienstein, A., et al.[2023]

In a pilot study involving 31 male military veterans with PTSD and severe anger issues, the TARGET therapy showed a significantly lower dropout rate (29%) compared to prolonged exposure therapy (64%), indicating better retention and potential acceptability of TARGET.

Both TARGET and prolonged exposure therapy led to improvements in emotion regulation, hope, and reductions in PTSD symptoms and mental health problems, suggesting that TARGET may be an effective treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial pilot study of prolonged exposure versus present centred affect regulation therapy for PTSD and anger problems with male military combat veterans. Ford, JD., Grasso, DJ., Greene, CA., et al.[2019]

Citations

1. academic.oup.com academic.oup.com/milmed/article/189/Supplement_3/842/7735958

Testing a Novel Trauma-Informed Treatment for Anger and ... This manuscript describes rationale, design, and methodology of a pilot clinical trial examining Countering Chronic Anger and Aggression Related ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39160870/

Testing a Novel Trauma-Informed Treatment for Anger and ... If outcomes show feasibility, acceptability, and initial effectiveness, CART will demonstrate a culturally relevant treatment for chronic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06609330

Treatment of Chronic Anger and Aggression Following ... The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work.

4. scholars.uthscsa.edu scholars.uthscsa.edu/en/publications/testing-a-novel-trauma-informed-treatment-for-anger-and-aggressio/

Testing a Novel Trauma-Informed Treatment for Anger and ... Materials and Methods: This manuscript describes rationale, design, and methodology of a pilot clinical trial examining Countering Chronic Anger ...

5. withpower.com withpower.com/trial/cart-for-anger-issues-b5099

CART for Anger Issues (CART Trial) The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work.

6. strongstar.org strongstar.org/research/strongstar/assessment-and-treatment-of-chronic-anger-and-aggression-following-military-relat/

Assessment and Treatment of Chronic Anger ... A pilot study to test a treatment that directly targets reducing chronic anger and aggression and improving interpersonal relationships.

7. vpr.uthscsa.edu vpr.uthscsa.edu/findastudy/protocol/40075

Assessment and Treatment of Chronic Anger and Aggression ... The purpose of this study is to test the effectiveness of Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CCAARTT), a novel ...