Present Centered Psychotherapy for PTSD

(MERA Trial)

Recruiting at 1 trial location

Overseen By Deveney Ching, MA

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

Trial Summary

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.

What data supports the effectiveness of the treatment Present Centered Psychotherapy for PTSD?

Research shows that Present Centered Psychotherapy (PCT) is effective for treating PTSD, with some studies finding it as effective as other established treatments. PCT also has lower dropout rates, meaning more people stick with it, which can be important for successful treatment. ^{1 2 3 4 5}

Is Present Centered Psychotherapy (PCT) safe for treating PTSD?

Present Centered Psychotherapy (PCT) is generally considered safe for treating PTSD, with lower dropout rates compared to other treatments and rare instances of symptom worsening. ^{1 6 7 8 9}

How is the treatment Manage Emotions to Reduce Aggression (MERA) for PTSD different from other treatments?

MERA is unique because it focuses on teaching emotion regulation skills to reduce impulsive aggression in PTSD patients, which is different from traditional therapies that may not specifically target emotion regulation. This approach is particularly beneficial for veterans who experience emotionally charged, unplanned aggression. ^{1 2 3 4 10}

What is the purpose of this trial?

PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.

Research Team

Shannon R. Miles, PhD

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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]

References

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

The evidence for present-centered therapy as a treatment for posttraumatic stress disorder. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. [2022]

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

A Comparison of Group Anger Management Treatments for Combat Veterans With PTSD: Results From a Quasi-Experimental Trial. [2022]

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

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing affect regulation and social problem-solving psychotherapies for mothers with victimization-related PTSD. [2011]

7. England pubmed.ncbi.nlm.nih.gov

Effects of cognitive processing therapy on PTSD-related negative cognitions in veterans with military sexual trauma. [2022]

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

Leveraging observational data to identify in-session patient and therapist predictors of cognitive processing therapy response and completion. [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Sequence matters: Combining Prolonged Exposure and EMDR therapy for PTSD. [2020]

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

Single-session emotion regulation skills training to reduce aggression in combat veterans: A clinical innovation case study. [2023]