Present Centered Psychotherapy for PTSD

(MERA Trial)

Recruiting at 1 trial location

Overseen By Briana N Chilton

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Suicidal, Homicidal, Bipolar, Psychotic, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help Veterans with PTSD (post-traumatic stress disorder) manage their emotions and reduce impulsive aggression, a common issue. It compares a new emotion regulation treatment, called Manage Emotions to Reduce Aggression (MERA), with a control group to determine if it better prepares Veterans for PTSD treatment. Veterans who have experienced combat since 9/11, have PTSD symptoms, and struggle with impulsive aggressive acts like yelling or hitting, might be a good fit for this study. The goal is to help Veterans improve their emotional coping skills and ultimately recover from PTSD. As an unphased trial, this study offers Veterans the opportunity to contribute to innovative research that could enhance PTSD treatment strategies.

Will I have to stop taking my current medications?

You won't have to stop taking your current medications, but you must agree not to change any psychotropic medications (medications that affect your mind, emotions, and behavior) during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Present Centered Psychotherapy (PCT) is generally safe and well-tolerated for treating PTSD. Studies have found that patients often continue with PCT treatment, possibly more than with some other therapies, suggesting it is manageable for most people.

Manage Emotions to Reduce Aggression (MERA) focuses on teaching skills to control emotions and reduce aggression. While specific safety data for MERA is unavailable, its emphasis on emotional management suggests it is likely low-risk. Both treatments aim to help Veterans better manage their emotions, potentially improving well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Present Centered Psychotherapy (PCT) and Manage Emotions to Reduce Aggression (MERA) for PTSD because these approaches focus on managing emotions and reducing aggression through concise therapy sessions. Unlike traditional PTSD treatments that often require long-term commitment, both PCT and MERA involve just three individual 90-minute sessions over three weeks, making them more accessible and time-efficient. Additionally, these therapies do not rely on medication, which can have side effects, but instead focus on improving emotional regulation and personal coping strategies. This could offer a promising alternative for individuals seeking effective, short-term treatment without the complications of pharmacotherapy.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that the Manage Emotions to Reduce Aggression (MERA) program, one of the treatments in this trial, can help Veterans with PTSD by reducing aggression and improving emotional management. In a small initial study, Veterans who participated in MERA demonstrated a noticeable decrease in aggressive behavior and better emotional control, with a moderate impact measured by Cohen's d = -0.55.

Studies also indicate that Present Centered Psychotherapy (PCT), another treatment option in this trial, effectively reduces the severity of PTSD symptoms. PCT works well for Veterans and is often as effective as other trauma-focused therapies. Overall, both treatments in this trial have strong evidence supporting their ability to help manage PTSD symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Shannon R. Miles, PhD

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Are You a Good Fit for This Trial?

This trial is for Veterans who served since 9/11, have PTSD or subthreshold PTSD, and show impulsive aggression. They must not change their psychotropic medications during the study and need an independent observer to verify aggressive acts.

Inclusion Criteria

I agree not to change my mental health medications during the study.

I am a veteran who served in a combat zone after 9/11.

I have someone over 18 who can report on my aggressive behaviors.

Exclusion Criteria

Currently suicidal with intent of self-harm in the last week

Currently homicidal with plans to hurt a specific person

I have been diagnosed with bipolar disorder or a psychotic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 individual 90-minute sessions of either MERA or PCT over 3 weeks

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

Long-term follow-up

Assessment of Evidence Based Psychotherapy (EBP) initiation at 6 months posttreatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Manage Emotions to Reduce Aggression
• Present Centered Psychotherapy

Trial Overview

The MERA trial compares a new 3-session emotion regulation treatment with a control group to see if it can reduce impulsive aggression in Veterans and prepare them for PTSD treatment.

How Is the Trial Designed?

Group I: Manage Emotions to Reduce Aggression (MERA) Experimental Treatment 1 Intervention

MERA is 3 individual 90-minute sessions delivered over 3 weeks.

Group II: Present Centered Psychotherapy (PCT) Active Control 1 Intervention

PCT delivered in 3 individual 90-minute sessions over 3 weeks.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Michael E. DeBakey VA Medical Center

Collaborator

Trials

68

Recruited

17,200+

Published Research Related to This Trial

In a study of 45 veterans with PTSD related to military sexual trauma, those who underwent cognitive processing therapy showed significantly lower negative cognition scores after treatment compared to those who received present centered therapy.

Negative cognitions were found to be positively correlated with the severity of PTSD, highlighting the importance of addressing these thoughts in treatment for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive processing therapy on PTSD-related negative cognitions in veterans with military sexual trauma. Holliday, R., Link-Malcolm, J., Morris, EE., et al.[2022]

In a study of 70 adult survivors of interpersonal violence undergoing Cognitive Processing Therapy (CPT) for PTSD, factors such as reduced patient fear and avoidance were strong predictors of better treatment outcomes, highlighting the importance of patient engagement in therapy.

Therapist behaviors also played a crucial role, with the use of Socratic dialogue significantly increasing the likelihood of treatment completion, while encouraging patient affect was linked to lower completion rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging observational data to identify in-session patient and therapist predictors of cognitive processing therapy response and completion. Alpert, E., Carpenter, JK., Smith, BN., 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]

Present-centered therapy (PCT) is more effective than control conditions in reducing PTSD severity, with moderate-quality evidence from 12 studies involving 1837 participants.

While PCT showed lower dropout rates compared to trauma-focused cognitive-behavioral therapy (TF-CBT), it did not demonstrate non-inferiority to TF-CBT in alleviating PTSD symptoms, suggesting that while PCT is beneficial, TF-CBT may still be more effective overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Belsher, BE., Beech, E., Evatt, D., et al.[2022]

Emotion dysregulation is a key factor linking PTSD to impulsive aggression in veterans, suggesting that improving emotional regulation could help reduce aggressive behaviors.

An innovative single-session emotion regulation treatment showed promise in two case studies of veterans with PTSD, indicating that such brief interventions may be beneficial, though further research is needed to confirm effectiveness across a broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-session emotion regulation skills training to reduce aggression in combat veterans: A clinical innovation case study. Miles, SR., Thompson, KE., Stanley, MA., et al.[2023]

Present-centered therapy (PCT) has been shown to be as effective as existing evidence-based treatments for PTSD in 3 out of 5 randomized clinical trials, with large effect sizes in cases where no treatment was provided.

PCT also had a significantly lower dropout rate (14.3%) compared to other treatments (31.3%), indicating it may be a more acceptable option for patients with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. Frost, ND., Laska, KM., Wampold, BE.[2022]

Both group cognitive behavioral therapy (CBT) and present-centered therapy (PCT) were effective in reducing anger and PTSD symptoms in a study of 36 combat veterans with PTSD, but no significant differences in effectiveness were found between the two therapies.

The study revealed that PCT may be more beneficial for reducing disability scores over time, and it highlighted a concerning dropout rate for female participants in the CBT group, with all of them leaving the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Group Anger Management Treatments for Combat Veterans With PTSD: Results From a Quasi-Experimental Trial. Van Voorhees, EE., Dillon, KH., Wilson, SM., et al.[2022]

In a study involving 106 PTSD patients undergoing an eight-day treatment program, those who received Prolonged Exposure (PE) therapy first followed by EMDR therapy experienced a significantly greater reduction in PTSD symptoms compared to those who had the reverse sequence.

Patients preferred the PE-first sequence, finding it more helpful, which suggests that the order of trauma-focused treatments can impact both efficacy and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequence matters: Combining Prolonged Exposure and EMDR therapy for PTSD. Van Minnen, A., Voorendonk, EM., Rozendaal, L., et al.[2020]

The trauma affect regulation therapy (TARGET) significantly improved PTSD symptoms and affect regulation in 146 low-income and ethnoracial minority mothers compared to a wait-list group, showing sustained benefits over a 6-month follow-up.

TARGET was more effective than present centered therapy (PCT) in maintaining improvements, with low rates of symptom worsening, suggesting that affect regulation-focused CBT could be a valuable alternative for treating PTSD without directly processing trauma memories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing affect regulation and social problem-solving psychotherapies for mothers with victimization-related PTSD. Ford, JD., Steinberg, KL., Zhang, W.[2011]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04793776

Manage Emotions to Reduce Aggression (MERA)

About 50% of Veterans with full and subthreshold posttraumatic stress disorder (PTSD) reported engaging in aggression after returning from deployment. This ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32947454/

Manage Emotions to Reduce Aggression: A Pilot Study of ...

Veterans in the intent-to-treat sample demonstrated a significant decrease in their frequency of aggression (Cohen's d = -0.55) and emotion dysregulation ( ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02724787

Using Emotion Regulation to Decrease Aggression in ...

The investigators for this study believe that equipping Veterans with emotion regulation skills and knowledge about PTSD treatments may help them initiate, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8966765/

Changes in anger and aggression after treatment for PTSD ...

PTSD treatments reduced anger and aggression with effects similar to anger and aggression treatments; innovative psychotherapies are needed.

5.

researchgate.net

researchgate.net/publication/344314914_Manage_Emotions_to_Reduce_Aggression_A_Pilot_Study_of_a_Brief_Treatment_to_Help_Veterans_Reduce_Impulsive_Aggression

A Pilot Study of a Brief Treatment to Help Veterans Reduce ...

Veterans in the intent-to-treat sample demonstrated a significant decrease in their frequency of aggression (Cohen's d = -0.55) and emotion dysregulation ( ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1359178917300332

Emotion dysregulation as an underlying mechanism of ...

Emotion dysregulation mediates relationship between impulsive aggression and PTSD. Teaching veterans with PTSD emotion regulation skills may reduce aggression.

7.

ptsd.va.gov

ptsd.va.gov/professional/articles/article-pdf/id1548219.pdf

Changes in anger and aggression after treatment for PTSD in ...

Objective: To examine whether treating posttraumatic stress disorder (PTSD) reduces anger and aggression and if changes in PTSD symptoms are associated with ...