AzTrials
AzTrials

Intimate Partner ViolenceMERA-CNCT07749755

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

A study testing Manage Emotions to Reduce Aggression- Couples and Manage Emotions to Reduce Aggression in people with Intimate Partner Violence, run by VA Office of Research and Development at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intimate Partner Violence
What is being tested?
Manage Emotions to Reduce Aggression- Couples and Manage Emotions to Reduce Aggression
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Jan 2027to 30 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julianne C Flanagan, PhD contact

(843) 577-5011

julianne.flanagan@va.gov

United States1 site
  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5703

    Julianne C Flanagan, PhD, (843) 577-5011, julianne.flanagan@va.gov

    Stacey S Sellers, MS, (843) 789-6703 ext. 206703, Stacey.Sellers@va.gov

Other trials in United States

About this study

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.

Read the 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.

Being tested
Manage Emotions to Reduce Aggression- Couples, Manage Emotions to Reduce Aggression
Keywords
Couples

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manage Emotions to Reduce Aggression- CouplesBehavioural

    Also called MERA-C

    4 weekly dyadic/couples therapy sessions of 45-60 minutes each.

  • Manage Emotions to Reduce AggressionBehavioural

    Also called MERA

    4 weekly individual therapy sessions of 45-60 minutes each.

Study groups in NCT07749755
Study groupRoleWhat they receive
MERA-CExperimentalPhase 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.
Receives: Behavioral: Manage Emotions to Reduce Aggression- Couples
MERAActive comparatorManage Emotions to Reduce Aggression (MERA). 4 weekly individual therapy sessions of 45-60 minutes each.
Receives: Behavioral: Manage Emotions to Reduce Aggression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 months

  2. 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.

    Measured: 2 months

  3. 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.

    Measured: 2 months

  4. 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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 3/Aim 3 of this study involves a behavioral intervention. MERA-C. The investigators anticipate that MERA-C will include 3 weekly sessions of 45-60 minutes each. Sessions will be delivered either in-person or via telehealth. Each partner will receive a client workbook that will contain session content, practice worksheets to complete between sessions, and weekly tracking forms to monitor progress. The investigators plan for MERA-C to begin with goal setting, psychoeducation about the adaptive nature of emotions, and how adverse childhood, military, and life experiences influence emotion regulation. MERA-C will adapt the existing MERA psychoeducation content to include relationship functioning and partner-directed thoughts, emotions, and behavior, and how partners' emotional expression influences one another.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749755
Sponsor's protocol ID
RRD4-006-25W
Other IDs
194392
Acronym
MERA-C
Status last verified
Jul 2026
First submitted
31 Jul 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Manage Emotions to Reduce Aggression- Couples and Manage Emotions to Reduce Aggression in people with Intimate Partner Violence, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julianne C Flanagan, PhD ((843) 577-5011, julianne.flanagan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Line Follow Back (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in