Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04793776
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-03-08
Brief Title:
Manage Emotions to Reduce Aggression MERA
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Manage Emotions to Reduce Aggression - MERA A Brief Aggression Treatment for Veterans With PTSD Symptoms
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MERA
Brief Summary:
PTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 911 Veterans with posttraumatic stress disorder PTSD report difficulty controlling impulsive aggression IA An inability to manage ones 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
Detailed Description:
Aggression can have devastating interpersonal and societal consequences including incarceration family violence disruption of treatment-facilitating factors and death About 50 of Veterans with full and subthreshold posttraumatic stress disorder PTSD reported engaging in aggression after returning from deployment This level of aggression is higher than Veterans without PTSD5 and civilians with PTSD Current psychotherapy options to reduce aggression include present centered therapies PCTs anger management and evidence based psychotherapies EBP for PTSD Anger management reduces aggression in civilian samples with small to moderate effect sizes However few anger management treatment studies have examined Veterans with PTSD and measured acts of aggression Consistently VA clinicians also provide PCTs and EBP for PTSD It is unknown how effectively PCTs reduce aggression Unfortunately even with gold standard EBP for PTSD Veterans only experience small to moderate reductions in aggression While any decline is an improvement these treatments leave room for novel methods to help Veterans reduce aggression
Emotion regulation ability may be a key to reducing aggression The team revealed that among Veterans with PTSD and aggression impulsive aggression emotionally charged reactive and uncontrolled is more common than premeditated aggression deliberate instrumental and planned Emotion dysregulation or the inability to detect emotions accept emotions andor engage in content-appropriate regulation is related to impulsive aggression and to PTSD severity The investigators demonstrated that emotion dysregulation fully mediated the relationship between PTSD and impulsive aggression in Veterans
Increasing emotion regulation ability of many emotions is an innovative method to reduce aggression Full-length treatments that incorporate emotion regulation training 8-12 sessions have augmented EBP for PTSD and improved Veterans emotion regulation skills However a brief format is needed for returning Veterans Eight weeks of treatment particularly when offered prior to EBP is an unfeasible commitment for many Veterans who are reintegrating into their communities Additionally most drop outs from EBP for PTSD occur prior to session three making the initial sessions a critical time for skill development Finally Veterans have experienced wait times to receive treatment due to the growing population of returning Veterans To address these challenges the team developed a 3-session emotion regulation treatment called Manage Emotions to Reduce Aggression MERA Male combat Veterans who completed MERA in an open trial N20 endorsed the brief model utilized the skills and found the treatment helpful at the 4-week follow up MERA had a low dropout rate of 8 from active treatment MERA completers demonstrated a medium to large pre- to post-treatment reduction in frequency of aggression Cohens d 073
The goal of the proposed study is to conduct a 2-site randomized clinical trial RCT to test if MERA is efficacious at reducing aggression and emotion dysregulation compared to 3 sessions of PCT which is often the standard of care for Veterans with aggression
Aim 1 Determine if MERA results in reductions in frequency of impulsive aggression compared to PCT in Veterans N 204 with subthreshold or full PTSD who have deployed for combat operations since 911
Hypothesis 1 MERA will demonstrate statistically significant greater reductions in frequency of aggression measured by the Overt Aggression Scale relative to PCT at the 2-month posttreatment assessment
Aim 2 Examine if MERA reduces emotion dysregulation relative to PCT Hypothesis 2 MERA will demonstrate statistically significant greater reductions in emotion dysregulation measured by Difficulties in Emotion Regulation Scale relative to PCT at the posttreatment assessment
Exploratory Aim Veterans who learn to regulate their emotions rather than avoid them may be more likely to engage in EBP for PTSD The investigators will examine if Veterans who complete MERA have higher rates of EBP initiation compared to Veterans who complete PCT Exploratory Hypothesis Veterans who complete MERA will have statistically significant higher rates of EBP initiation than Veterans who complete PCT
If the hypotheses are supported the VA will have a brief treatment that can help Veterans manage their aggression by directly targeting emotion dysregulation MERA may also be applicable to Veterans with emotion dysregulation and other psychological disorders
Emotion regulation ability may be a key to reducing aggression The team revealed that among Veterans with PTSD and aggression impulsive aggression emotionally charged reactive and uncontrolled is more common than premeditated aggression deliberate instrumental and planned Emotion dysregulation or the inability to detect emotions accept emotions andor engage in content-appropriate regulation is related to impulsive aggression and to PTSD severity The investigators demonstrated that emotion dysregulation fully mediated the relationship between PTSD and impulsive aggression in Veterans
Increasing emotion regulation ability of many emotions is an innovative method to reduce aggression Full-length treatments that incorporate emotion regulation training 8-12 sessions have augmented EBP for PTSD and improved Veterans emotion regulation skills However a brief format is needed for returning Veterans Eight weeks of treatment particularly when offered prior to EBP is an unfeasible commitment for many Veterans who are reintegrating into their communities Additionally most drop outs from EBP for PTSD occur prior to session three making the initial sessions a critical time for skill development Finally Veterans have experienced wait times to receive treatment due to the growing population of returning Veterans To address these challenges the team developed a 3-session emotion regulation treatment called Manage Emotions to Reduce Aggression MERA Male combat Veterans who completed MERA in an open trial N20 endorsed the brief model utilized the skills and found the treatment helpful at the 4-week follow up MERA had a low dropout rate of 8 from active treatment MERA completers demonstrated a medium to large pre- to post-treatment reduction in frequency of aggression Cohens d 073
The goal of the proposed study is to conduct a 2-site randomized clinical trial RCT to test if MERA is efficacious at reducing aggression and emotion dysregulation compared to 3 sessions of PCT which is often the standard of care for Veterans with aggression
Aim 1 Determine if MERA results in reductions in frequency of impulsive aggression compared to PCT in Veterans N 204 with subthreshold or full PTSD who have deployed for combat operations since 911
Hypothesis 1 MERA will demonstrate statistically significant greater reductions in frequency of aggression measured by the Overt Aggression Scale relative to PCT at the 2-month posttreatment assessment
Aim 2 Examine if MERA reduces emotion dysregulation relative to PCT Hypothesis 2 MERA will demonstrate statistically significant greater reductions in emotion dysregulation measured by Difficulties in Emotion Regulation Scale relative to PCT at the posttreatment assessment
Exploratory Aim Veterans who learn to regulate their emotions rather than avoid them may be more likely to engage in EBP for PTSD The investigators will examine if Veterans who complete MERA have higher rates of EBP initiation compared to Veterans who complete PCT Exploratory Hypothesis Veterans who complete MERA will have statistically significant higher rates of EBP initiation than Veterans who complete PCT
If the hypotheses are supported the VA will have a brief treatment that can help Veterans manage their aggression by directly targeting emotion dysregulation MERA may also be applicable to Veterans with emotion dysregulation and other psychological disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX002135 | OTHER_GRANT | VA Clinical Science Research Development | None |