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

Trial Summary

What is the purpose of this 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. The study will be done on active duty military service members and veterans aged 18 or older. The main questions it aims to answer are: * Will participants be satisfied with the treatment, and is the treatment feasible to do in a military outpatient setting * Will the treatment help with anger and aggression issues. Researchers will compare differences in groups that have different wait times (2-, 3-, or 4-weeks). Participants will complete surveys before, during and after the treatment. The treatment will be 14 modules given twice a week. About 1 month after treatment ends, surveys will be taken again.

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 data supports the effectiveness of the treatment CART for Anger Issues?

Research on similar treatments, like Trauma Affect Regulation: Guide for Education and Therapy (TARGET), shows promise in reducing anger and improving emotion regulation in people with PTSD and anger issues, suggesting that CART might also be effective. ^{1 2 3 4 5}

Is MDMA-assisted therapy safe for humans?

MDMA-assisted therapy has been shown to be safe and well-tolerated in clinical trials for severe PTSD, with no significant adverse events related to abuse potential, suicidality, or heart issues. ^{6 7 8 9 10}

How is the CART treatment for anger issues different from other treatments?

CART is unique because it specifically targets chronic anger and aggression related to trauma and transgressions, which is not commonly addressed by existing treatments. Unlike other therapies, it may incorporate elements from treatments like TARGET, which have shown promise in improving emotion regulation and reducing PTSD symptoms in military veterans with anger issues. ^{1 2 11 12 13}

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Moderating Effect of State Anger on Treatment Outcome in Female Adolescents With PTSD. [2020]

2. England 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for severe anger in posttraumatic stress disorder. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Childhood trauma and anger in adults with and without depressive and anxiety disorders. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of anger and treatment outcome in combat veterans with posttraumatic stress disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Open trial of citalopram in adults with post-traumatic stress disorder. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacological prevention and early treatment of post-traumatic stress disorder and acute stress disorder: a systematic review and meta-analysis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

MDMA-Assisted Therapy for Severe PTSD: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an Anger Intervention for Military Members with PTSD: A Clinical Case Series. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Perceived friendships protect against the development of anger following childhood adversities in UK military veteran men residing in Northern Ireland. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Doing anger differently: a group percussion therapy for angry adolescent boys. [2010]