Adapting the Manage Emotions to Reduce Aggression Therapy to Reduce Intimate Partner Violence and Promote Psychosocial Recovery in Veteran Couples (MERA-C)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Manage Emotions to Reduce Aggression- Couples, Manage Emotions to Reduce Aggression.
- Who it may be relevant to
- Registry conditions: Intimate Partner Violence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will address a pressing unmet need for effective and accessible treatment for Veteran couples with intimate partner violence (IPV). The primary objective is to adapt a brief intervention originally developed to reduce general aggression among individual Veterans with PTSD symptoms (Manage Emotions to Reduce Aggression; MERA) to reduce IPV among Veteran couples. First, the investigators will conduct stakeholder interviews to inform the content, dose, and timing of the adapted MERA-Couples manual (MERA-C). Second, the investigators will examine the preliminary feasibility and acceptability of MERA-C through a single-arm feasibility trial among 10 Veteran couples with IPV. Finally, the investigators will conduct a pilot randomized controlled trial (N= 60 couples) to examine the preliminary within- and between-couple effects of MERA-C versus MERA on (1) participant acceptability and retention and (2) physical and psychological IPV occurrence; emotion regulation; relationship functioning; and psychosocial functioning from pre- to post-treatment and at 1-month follow-up.
Detailed description
SPECIFIC AIMS Intimate partner violence (IPV), which includes a wide spectrum of physical and non-physical behaviors, is a serious and prevalent public health problem that disproportionately affects the Veteran population. IPV is most commonly bidirectional, meaning that both partners in a couple use aggression towards one another at both the couple and the event levels. It is also characterized by lower severity, a high degree of frequency and severity symmetry between partners, and reactive rather than premeditated aggression. IPV directly impacts Veterans Health Administration (VHA) operations: Up to 49% of Veterans who used VHA health care in the past year reported using IPV and similar proportions report experiencing victimization. IPV is associated with myriad detrimental outcomes, including significant physical and mental health problems, housing instability, suicidality, and reduced quality of life and psychosocial functioning. Unsurprisingly, Veterans who experience IPV are more likely to subsequently utilize VHA services compared to those who do not.
While VHA has greatly improved reliable trauma-informed IPV victimization screening and referral practices there is substantial room to improve intervention options to reduce IPV use. Despite the widely varying nature of IPV experiences and treatment preferences among Veterans, only one IPV intervention program is currently available at select VHA facilities. Strength at Home consists of 12 x 1 hour group therapy sessions for individual Veterans, most of whom are men (81%) involved in the criminal justice system (62%). Just as more than one treatment option is available to Veterans for common presenting problems in the psychosocial health arena, a one-size-fits-all approach is insufficient to address the complex and inherently dyadic problem of IPV among Veterans4. A brief dyadic approach is safe, feasible, and acceptable for couples engaging in less severe and bidirectional forms of "situational" or "common" couple violence16 and consistent with Veterans' IPV-focused treatment preferences as compared to lengthier individual or group modalities.
The existing literature agrees that posttraumatic stress disorder (PTSD), a common mental health concern among Veterans seeking VHA services, exacerbates risk for IPV use. This salient link is commonly explained by social information processing theory, which suggests that individuals with PTSD incur heightened risk for IPV use as a result of hostile attribution bias, excessive perception of threat, chronic emotional and physiological hyperarousal, and impaired emotion regulation capabilities. Indeed, difficulty with emotion regulation, or the process through which people manage their emotional experiences and emotional expression, is common among Veterans, a central feature of PTSD, a known risk factor for IPV, and a promising IPV intervention target. Notably, recent empirical literature among couples has highlighted the role of emotional co-regulation in mediating both adaptive and maladaptive couple conflict behaviors including IPV.
The purpose of the proposed Stage 1a/1b study is to create a novel dyadic adaptation of the Manage Emotions to Reduce Aggression (MERA) therapy protocol (i.e., MERA-Couples or MERA-C). In its current form, the MERA treatment is a brief trauma-informed cognitive behavioral modality designed to reduce impulsive general aggression among individual Veterans with PTSD symptoms. Findings from a published single arm clinical trial of MERA among male Veterans (N=27, CX001337, PI: Miles) indicated strong feasibility and acceptability and substantial reductions in aggression with medium-to-large effect sizes and medium effect sizes in emotion regulation improvement. Dr. Miles (MPI) is currently testing MERA's efficacy in a VA-sponsored two-site Stage II trial (N=204, CX002135). Retention in the treatment phase is 96% to date, with 76% of participants being partnered. Importantly, MERA was developed specifically for Veterans with PTSD symptoms within VHA and is presently available to any VA provider to administer with their patients. Thus, adapting MERA to address IPV among Veteran couples (MERA-C) is one promising pathway to better address the rehabilitation and recovery needs of Veteran couples experiencing IPV.
Specific Aim 1: Conduct semi-structured stakeholder interviews with Veteran couples (N= 10 couples) and VHA mental health treatment providers (N= 10 providers) to adapt the MERA manual into MERA-C.
Specific Aim 2: Conduct a single-arm pilot test of the MERA-C intervention among Veteran couples (N= 10 couples) to further refine the adapted treatment manual.
Specific Aim 3: Conduct a pilot randomized controlled trial (N= 60 couples) to compare the effects of MERA-C to MERA on (a) participant acceptability and retention and (b) IPV occurrence; emotion regulation; relationship functioning; and psychosocial functioning from pre- to post-treatment and at 1-month follow-up.
This study is directly responsive to several VHA priorities. The investigators will translate a transdiagnostic mechanism of behavior change (i.e., emotion regulation) into urgently needed and more accessible clinical intervention for Veterans with IPV. This study addresses a high priority comorbidity of PTSD and IPV and does so among couples to create sustainable change. The MERA-C treatment manual will be immediately available to providers and the study team is ideally positioned to disseminate and implement MERA-C among Veterans in the long-term.
Interventions
- Behavioral Manage Emotions to Reduce Aggression- Couples
4 weekly dyadic/couples therapy sessions of 45-60 minutes each. - Behavioral Manage Emotions to Reduce Aggression
4 weekly individual therapy sessions of 45-60 minutes each.
Primary outcome measures
- Time Line Follow Back [Time frame: 2 months]
- Difficulties in Emotion Regulation Scale [Time frame: 2 months]
- Dyadic Adjustment Scale-7 [Time frame: 2 months]
- Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
Veteran and Partner Inclusion criteria
- At least one partner in each couple must be a U.S. military Veteran
- Married, cohabiting, or in a committed relationship for at least 6 months
- Cognitive functioning sufficient to provide informed consent and participate accurately (≥ 23 on the Mini-Mental Status Exam \[MMSE\])
- Veteran meets criteria for subthreshold PTSD or greater (Criterion A plus scoring 2 or higher on at least one symptom from each of clusters B, C, D, and E as measured by the PCL-5)
- At least 1 instance of mild or moderate physical intimate partner violence (IPV) in the current relationship in the past year (as defined by the Revised Conflict Tactics Scale \[CTS-2\])
- Not currently enrolled in couple therapy
- Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results
Exclusion criteria
Veteran and Partner Exclusion criteria
- Any severe physical or sexual IPV (as measured by the CTS-2) at any time in the current relationship
- Having a psychiatric condition requiring a higher level of care as assessed by the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID), such as psychotic or bipolar disorders. Those participants will be referred clinically.
- Severe substance use disorder. Nicotine dependence is allowed. Participants requiring specialty care for substance use disorders or smoking cessation aid will be referred clinically.
- Current suicidal, self-harm behavior, or homicidal ideation and intent requiring a higher level of care or who are likely to require hospitalization during the study. Those participants will be referred clinically.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston
Identifiers
NCT: NCT07749755 · RRD4-006-25W · 194392