Adapting the Manage Emotions to Reduce Aggression Therapy to Reduce Intimate Partner Violence and Promote Psychosocial Recovery in Veteran Couples (MERA-C) (MERA-C)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: Manage Emotions to Reduce Aggression- Couples; Behavioral: Manage Emotions to Reduce Aggression

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey S Sellers, MS; Phone Number: 206703 (843) 789-6703; Email: Stacey.Sellers@va.gov
• Study Contact Backup: Name: Julianne C Flanagan, PhD; Phone Number: (843) 577-5011; Email: julianne.flanagan@va.gov

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5703
      • Ralph H. Johnson VA Medical Center, Charleston, SC
      • Principal Investigator: Julianne Christina Flanagan, PhD
      • Contact: Stacey S Sellers, MS; Phone Number: 206703 (843) 789-6703; Email: Stacey.Sellers@va.gov
      • Contact: Julianne C Flanagan, PhD; Phone Number: (843) 577-5011; Email: julianne.flanagan@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Veteran and Partner Inclusion criteria

1. At least one partner in each couple must be a U.S. military Veteran
2. Married, cohabiting, or in a committed relationship for at least 6 months
3. Cognitive functioning sufficient to provide informed consent and participate accurately (≥ 23 on the Mini-Mental Status Exam [MMSE])
4. 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)
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])
6. Not currently enrolled in couple therapy
7. 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

1. Any severe physical or sexual IPV (as measured by the CTS-2) at any time in the current relationship
2. 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.
3. Severe substance use disorder. Nicotine dependence is allowed. Participants requiring specialty care for substance use disorders or smoking cessation aid will be referred clinically.
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MERA-C; Phase 3/Aim 3 of this study involves a behavioral intervention. Manage Emotions to Reduce Aggression-Couples (MERA-C). Although the exact duration and timing of MERA-C will be established in Aim 1, the investigators anticipate that MERA-C will be the same duration as individual MERA: 4 weekly couples/dyadic therapy sessions of 45-60 minutes each.	Behavioral: Manage Emotions to Reduce Aggression- Couples; 4 weekly dyadic/couples therapy sessions of 45-60 minutes each.; Other Names: MERA-C
Active Comparator: MERA; Manage Emotions to Reduce Aggression (MERA). 4 weekly individual therapy sessions of 45-60 minutes each.	Behavioral: Manage Emotions to Reduce Aggression; 4 weekly individual therapy sessions of 45-60 minutes each.; Other Names: MERA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Line Follow Back	The Time Line Follow-Back (TLFB) will be used as the primary IPV assessment given the need for a count variable to compare time points at varying intervals. The TLFB is a calendar-assisted, semi-structured interview assessing daily quantity and frequency of alcohol and drug consumption (e.g., cannabis) and IPV use and victimization. Participants report the total number of days substances are used and the amount of substance used (e.g., standard drink units for alcohol) and the days on which IPV use and/or victimization occurred as well as each partner's specific IPV behaviors. The TLBF will be administered at baseline to study participation and at each subsequent time point.	2 months
Difficulties in Emotion Regulation Scale	The Difficulties in Emotion Regulation Scale (DERS-16) is a 36-item self-report measure that assesses 6 facets of emotion regulation: nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Respondents are asked to indicate how frequently each item applies to them, from 1 ("almost never, 0-10% of the time") to 5 ("almost always, 91-100% of the time"). Higher scores indicate greater difficulties with emotion regulation. The DERS has demonstrated strong internal consistency and good construct validity among treatment-seeking adults.	2 months
Dyadic Adjustment Scale-7	The Dyadic Adjustment Scale-7 (DAS-7) is a psychometrically sound alternative to the original 32-item measure. The DAS-7 assesses domains of relationship functioning. Six items are rated on a 6-point Likert scale and 1 item is rated on a 7-point scale, for a total score ranging from 0-36 (higher scores indicate more positive relationship adjustment and less distress). The DAS-7 has demonstrated good internal consistency and construct validity and effectively discriminates between distressed and non-distressed couples.	2 months
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form	The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16-item self-report measure assessing overall enjoyment and satisfaction with life domains. Responses range from 1 ("not at all or never") to 5 ("frequently or all the time"). Fourteen items are summed to create a total score of 14-70, with higher scores indicating greater life satisfaction. There is no specific clinical cutoff score for this measure. The two items that are not included in the total score assess medications and overall life satisfaction. The Q-LES-Q-SF has demonstrated strong psychometric properties, is sensitive to change over time, and is suitable for assessing treatment outcomes.	2 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Julianne Christina Flanagan, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: July 31, 2026
• First Submitted That Met QC Criteria: July 31, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Couples
• Other Study ID Numbers: RRD4-006-25W; 194392 (Other Identifier: VA IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No